05 - Rationale for a preliminary operational definition of physical frailty and sarcopenia in the SPRINTT trial.
1. Health and Technology, 2019 1-11 https://doi.org/10.1007/s12553-019-00320-9
1 Using socially assistive robots for monitoring and preventing frailty among older adults: a study on usability and user experience challenges.
Richelle A. C. M. Olde Keizer1 & Lex van Velsen1,2 & Mathieu Moncharmont3 & Brigitte Riche3 & Nadir Ammour3 &
Susanna Del Signore4 & Gianluca Zia5 & Hermie Hermens1,2 & Aurèle N’Dja3
Author information
- eHealth Group Roessingh Research and development Enschede The Netherlands
- Biomedical Signals and Systems Group University of Twente Enschede The Netherlands
- Sanofi R&D, Paris, France
- Bluecompanion ltd, London, UK.
- Caretek s.r.l, Turin, Italy.
Abstract
Socially assistive robots can play an important role in the monitoring and training of health of older adults. But before their benefits can be reaped, proper usability and a positive user experience need to be ensured.
In this study, we tested the usability and user experience of a socially assistive robot (the NAO humanoid robot) to monitor and train the health of frail older adults. They were asked to complete a set of health monitoring and physical training tasks, once provided by the NAO robot, and once provided by a Tablet PC application (as a reference technology). After using each technology, they completed the System Usability Scale for usability, and a set of rating scales for perceived usefulness, enjoyment, and control. Finally, we questioned the participants’ preference for one of the technologies. All interactions were recorded on video and scrutinized for usability issues. Twenty older adults participated. They awarded both technologies ‘average’ usability scores. Perceived usefulness and enjoyment were rated as very positive for both modalities; control was scored positively. Main usability issues for NAO for these tasks were related to speech interaction (e.g., NAO’s limited speech library, NAO’s difficulty to cope with Dutch dialect), older adults’ difficulties with taking their proper role in human-robot interaction, and a lack of affordances of NAO. Seven participants preferred NAO: it was easier to use and more personal.
Social robots have the potential to monitor and train the health of frail older adults, but some critical usability challenges need to be overcome first.
2. BMC Geriatr. 2019 Mar 21;19(1):88. doi: 10.1186/s12877-019-1089-z.
A comparison between an ICT tool and a traditional physical measure for frailty evaluation in older adults.
Mulasso A1, Brustio PR1, Rainoldi A2, Zia G3, Feletti L3, N'dja A4, Del Signore S5, Poggiogalle E6, Luisi F6, Donini LM6.
- NeuroMuscular Function Research Group, School of Exercise and Sport Sciences, Department of Medical Sciences, University of Torino, Torino, Italy.
- NeuroMuscular Function Research Group, School of Exercise and Sport Sciences, Department of Medical Sciences, University of Torino, Torino, Italy.
This email address is being protected from spambots. You need JavaScript enabled to view it. - Caretek s.r.l, Turin, Italy.
- Sanofi-Aventis R&D, Chilly-Mazarin, France.
- Bluecompanion ltd, London, UK.
- Food Science and Human Nutrition Research Unit, Department of Experimental Medicine, Sapienza University, Rome, Italy.
PMID: 30898096 PMCID: PMC6427849 DOI: 10.1186/s12877-019-1089-z
Abstract
BACKGROUND:
METHODS:
Twenty-five community-dwelling older adults (71 ± 6 years; 60% women) wore ADAMO continuously for a week. The time percentage spent in Low, Moderate and Vigorous Activities was assessed using ADAMO system. Walking ability and frailty were measured using the 400 m walk test and the Tilburg Frailty Indicator, respectively.
RESULTS:
Controlling for age and gender, the ANCOVA showed that frail and robust participants were different for Low (frail = 58.8%, robust = 42.0%, p < 0.001), Moderate (frail = 25.5%, robust = 33.8%, p = 0.008), and Vigorous Activity (frail = 15.7%, robust = 24.2%, p = 0.035). Using cluster analysis, participants were divided into two groups, one with higher and one with lower mobility. Controlling for age and gender, linear regression showed that the MI clusters were associated with total (β = 0.571, p = 0.002), physical (β = 0.381, p = 0.031) and social (β = 0.652, p < 0.001) frailty; and the 400 m walk test was just associated with total (β = 0.404, p = 0.043) and physical frailty (β = 0.668, p = 0.002).
CONCLUSION:
ADAMO system seems to be a suitable time tracking that allows to measure mobility levels in a non-intrusive way providing wider information on individual health status and specifically on frailty. For the frail individuals with an important loss of resources in physical domain, this innovative device may represent a considerable help in preventing physical consequences and in monitoring functional status.
KEYWORDS:
Health status; ICT tool; Physical functioning; Physical measure; Sarcopenia
PMID: 30898096 PMCID: PMC6427849 DOI:10.1186/s12877-019-1089-z
3. Stud Health Technol Inform. 2018;247:651-655.
The Reliability of Using Tablet Technology for Screening the Health of Older Adults.
van Velsen L(1), Frazer S(1), N'dja A(2), Ammour N(2), Del Signore S(3), Zia G(4), Hermens H(1).
Author information:
(4) Caretek s.r.l., Italy.
In this study, we assessed the reliability of using a tablet application for collecting health data among older adults, in comparison to using paper surveys for this goal. Test-retest reliability between the two modalities, usability, user experience factors, and older adults' preference were determined. The results show perfect agreement between tablet and paper for the SARC-F and high agreement for the SF-36 physical scale and EQ-5D. Usability and user experience factors were perceived the same for both modalities. The majority of the participants preferred the tablet for health screening purposes, mainly because of its ease of use. This study shows that using tablets for health screenings among older adults does not affect test reliability, and that older adults prefer the tablet to paper for completing these tests.
PMID: 29678041 [Indexed for MEDLINE]
4. J Frailty Aging. 2018;7(1):2-9. doi: 10.14283/jfa.2017.30.
Implications of ICD-10 for Sarcopenia Clinical Practice and Clinical Trials: Report by the International Conference on Frailty and Sarcopenia Research Task Force.
Vellas B(1), Fielding RA, Bens C, Bernabei R, Cawthon PM, Cederholm T, Cruz-Jentoft AJ, Del Signore S, Donahue S, Morley J, Pahor M, Reginster JY, Rodriguez Mañas L, Rolland Y, Roubenoff R, Sinclair A, Cesari M.
Author information:
(1) Bruno Vellas, MD. Gérontopôle, CHU Toulouse, Service de Médecine Interne et Gérontologie, Clinique, 170 Avenue de Casselardit, 31059 Toulouse, France. Phone: +33 (0) 5 6177-6425; Fax: +33 (0) 6177-6475. Email:
Establishment of an ICD-10-CM code for sarcopenia in 2016 was an important step towards reaching international consensus on the need for a nosological framework of age-related skeletal muscle decline. The International Conference on Frailty and Sarcopenia Research Task Force met in April 2017 to discuss the meaning, significance, and barriers to the implementation of the new code as well as strategies to accelerate development of new therapies. Analyses by the Sarcopenia Definitions and Outcomes Consortium are underway to develop quantitative definitions of sarcopenia. A consensus conference is planned to evaluate this analysis. The Task Force also discussed lessons learned from sarcopenia trials that could be applied to future trials, as well as lessons from the osteoporosis field, a clinical condition with many constructs similar to sarcopenia and for which ad hoc treatments have been developed and approved by regulatory agencies.
DOI: 10.14283/jfa.2017.30
PMID: 29412436 [Indexed for MEDLINE]
5. Aging Clin Exp Res. 2017 Feb;29(1):81-88. doi: 10.1007/s40520-016-0716-1. Epub 2017 Feb 10.
Rationale for a preliminary operational definition of physical frailty and sarcopenia in the SPRINTT trial.
Cesari M1,2, Landi F3, Calvani R3, Cherubini A4, Di Bari M5,6, Kortebein P7,8,9, Del Signore S10, Le Lain R11, Vellas B12,13, Pahor M14, Roubenoff R15, Bernabei R3, Marzetti E3; SPRINTT Consortium.
Author information:
- Gérontopôle, Centre Hospitalier Universitaire de Toulouse III, Paul Sabatier, 37 Allées Jules Guesde, 31000, Toulouse, France
- Université de Toulouse III Paul Sabatier, Toulouse, France
- Department of Geriatrics, Neurosciences and Orthopedics, Catholic University of the Sacred Heart School of Medicine, Rome, Italy.
- Geriatrics and Geriatric Emergency Care, IRCCS-INRCA, Ancona, Italy.
- Research Unit of Medicine of Aging, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
- Division of Geriatric Cardiology and Medicine, Department of Geriatrics and Medicine, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
- Physical Medicine and Rehabilitation Service, Sacramento VA Medical Center, Sacramento, CA, USA.
- Department of Physical Medicine and Rehabilitation, University of California Davis, Sacramento, CA, USA.
- Novartis Institutes of Biomedical Research, Cambridge, MA, USA.
- Bluecompanion LTD, London, UK.
- Sanofi R&D, Chilly-Mazarin, France.
- Gérontopôle, Centre Hospitalier Universitaire de Toulouse III, Paul Sabatier, 37 Allées Jules Guesde, 31000, Toulouse, France.
- Université de Toulouse III Paul Sabatier, Toulouse, France.
- Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.
- Global Translational Medicine, Novartis Institutes for Biomedical Research, Basel, Switzerland.
In the present article, the rationale that guided the operationalization of the theoretical concept of physical frailty and sarcopenia (PF&S), the condition of interest for the "Sarcopenia and Physical Frailty in Older People: Multicomponent Treatment Strategies" (SPRINTT) trial, is presented. In particular, the decisions lead to the choice of the adopted instruments, and the reasons for setting the relevant thresholds are explained. In SPRINTT, the concept of physical frailty is translated with a Short Physical Performance Battery score of ≥3 and ≤9.
Concurrently, sarcopenia is defined according to the recent definitions of low muscle mass proposed by the Foundation for the National Institutes of Health-Sarcopenia Project. Given the preventive purpose of SPRINTT, older persons with mobility disability (operationalized as incapacity to complete a 400-m walk test within 15 min; primary outcome of the trial) at the baseline are not included within the diagnostic spectrum of PF&S.
DOI: 10.1007/s40520-016-0716-1
PMID: 28188558 [Indexed for MEDLINE]
6. AGING CLIN EXP RES. 2017 FEB;29(1):69-74. DOI: 10.1007/S40520-016-0710-7. EPUB 2017 FEB 3.
&NBSP;
Physical frailty and sarcopenia (PF&S): a point of view from the industry.
Del Signore S1, Roubenoff R2.
Author information:
- Bluecompanion Ltd, 6 London Street, London, W2 1HR, UK.
This email address is being protected from spambots. You need JavaScript enabled to view it. . - Global Translational Medicine, Novartis Institutes for Biomedical Research,
Basel, Switzerland.
We have observed over the last 15 years a wide debate both in the medical scientific community and in the public health arena on the definition and operationalization of frailty, typically a geriatric condition, and in particular of physical frailty linked to sarcopenia. Because physical frailty in its initial phase can still be reversed, fighting sarcopenia in elderly persons has the potential to slow or halt progressive decline towards disability and dependency. Quite recently, regulators focused attention on frailty as an indicator of biological age to be measured to characterize elderly patients before their inclusion in clinical trials. A European guidance regarding most adapted evaluation instruments of frailty is currently under public consultation. Does the regulatory initiative imply we should now consider frailty, and particularly physical frailty, primarily as an important risk factor for adverse events and poor response, or mainly as a clinical tool helping the physician to opt for one therapeutic pathway or another? Or is physical frailty above all a specific geriatric condition deserving an effective and innovative therapeutic approach with the objective to curb the incidence of its most common result, e.g., mobility disability? Pharmaceutical industry developers consider both faces of the coin very relevant. We agree with regulators that better characterization of subpopulations, not only in elderly patients, can improve the benefit risk ratio of medicines. At the same time, we believe it is in the public health interest to develop novel drugs indicated for specific geriatric conditions, like osteoporosis in the 1990s and sarcopenia today. We consider it an important therapeutic goal to effectively delay mobility disability and to extend the active, independent, and healthy life years of aging people. The "Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies" (SPRINTT) collaborative project under IMI is paving the way for adapted methodologies to study the change of physical frailty and sarcopenia in at-risk older persons and to adequately characterize the population that needs to be treated.
DOI: 10.1007/s40520-016-0710-7
PMID: 28160253 [Indexed for MEDLINE]
7. Genome Med. 2016 Jun 23;8(1):71. doi: 10.1186/s13073-016-0323-y.
Making sense of big data in health research: Towards an EU action plan.
Auffray C(1)(2), Balling R(3), Barroso I(4), Bencze L(5), Benson M(6), Bergeron J(7), Bernal-Delgado E(8), Blomberg N(9), Bock C(10)(11)(12), Conesa A(13)(14), Del Signore S(15), Delogne C(16), Devilee P(17), Di Meglio A(18), Eijkemans M(19), Flicek P(20), Graf N(21), Grimm V(22), Guchelaar HJ(23), Guo YK(24), Gut IG(25), Hanbury A(26), Hanif S(27), Hilgers RD(28), Honrado Á(29), Hose DR(30), Houwing-Duistermaat J(31), Hubbard T(32)(33), Janacek SH(20), Karanikas H(34), Kievits T(35), Kohler M(36), Kremer A(37), Lanfear J(38), Lengauer T(12), Maes E(39), Meert T(40), Müller W(41), Nickel D(42), Oledzki P(43), Pedersen B(44), Petkovic M(45), Pliakos K(46), Rattray M(41), I Màs JR(47), Schneider R(48), Sengstag T(49), Serra-Picamal X(50), Spek W(51), Vaas LA(36), van Batenburg O(51), Vandelaer M(52), Varnai P(53), Villoslada P(54), Vizcaíno JA(20), Wubbe JP(55), Zanetti G(56)(57).
Author information:
- European Institute for Systems Biology and Medicine, 1 avenue Claude Vellefaux, 75010, Paris, France.
This email address is being protected from spambots. You need JavaScript enabled to view it. . - CIRI-UMR5308, CNRS-ENS-INSERM-UCBL, Université de Lyon, 50 avenue Tony Garnier, 69007, Lyon, France.
This email address is being protected from spambots. You need JavaScript enabled to view it. . - Luxembourg Centre for Systems Biomedicine, University of Luxembourg, 7 Avenue des Hauts Fourneaux, 4362, Esch-sur-Alzette, Luxembourg.
This email address is being protected from spambots. You need JavaScript enabled to view it. . - Wellcome Trust Sanger Institute, Wellcome Genome Campus, Hinxton, Cambridge, CB10 1SA, UK.
- Health Services Management Training Centre, Faculty of Health and Public Services, Semmelweis University, Kútvölgyi út 2, 1125, Budapest, Hungary.
- Centre for Personalised Medicine, Linköping University, 581 85, Linköping, Sweden.
- Translational & Bioinformatics, Pfizer Inc., 300 Technology Square, Cambridge, MA, 02139, USA.
- Institute for Health Sciences, IACS - IIS Aragon, San Juan Bosco 13, 50009, Zaragoza, Spain.
- ELIXIR, Wellcome Genome Campus, Hinxton, Cambridge, CB10 1SD, UK.
- CeMM Research Center for Molecular Medicine of the Austrian Academy of Sciences, Lazarettgasse 14, AKH BT25.2, 1090, Vienna, Austria.
- Department of Laboratory Medicine, Medical University of Vienna, Lazarettgasse 14, AKH BT25.2, 1090, Vienna, Austria.
- Max Planck Institute for Informatics, Campus E1 4, 66123, Saarbrücken, Germany.
- Príncipe Felipe Research Center, C/ Eduardo Primo Yúfera 3, 46012, Valencia, Spain.
- University of Florida, Institute of Food and Agricultural Sciences (IFAS), 2033 Mowry Road, Gainesville, FL, 32610, USA.
- Bluecompanion Ltd, 6 London Street (second floor), London, W2 1HR, UK.
- Technology, Data & Analytics, KPMG Luxembourg, Société Coopérative, 39 Avenue John F. Kennedy, 1855, Luxembourg, Luxembourg.
- Department of Human Genetics, Department of Pathology, Leiden University Medical Centre, Einthovenweg 20, 2333 ZC, Leiden, The Netherlands.
- Information Technology Department, European Organization for Nuclear Research (CERN), 385 Route de Meyrin, 1211, Geneva 23, Switzerland.
- Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, 3508 GA, Utrecht, The Netherlands.
- European Molecular Biology Laboratory, European Bioinformatics Institute (EMBL-EBI), Wellcome Genome Campus, Hinxton, Cambridge, CB10 1SD, UK.
- Department of Pediatric Oncology/Hematology, Saarland University, Campus Homburg, Building 9, 66421, Homburg, Germany.
- Project Management Jülich, Forschungszentrum Jülich GmbH, Wilhelm-Johnen-Straße, 52428, Jülich, Germany.
- Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
- Data Science Institute, Imperial College London, South Kensington, London, SW7 2AZ, UK.
- CNAG-CRG, Center for Genomic Regulation, Barcelona Institute for Science and Technology (BIST), C/Baldiri Reixac 4, 08029, Barcelona, Spain.
- Institute of Software Technology and Interactive Systems, TU Wien, Favoritenstrasse 9-11/188, 1040, Vienna, Austria.
- The Association of the British Pharmaceutical Industry, 7th Floor, Southside, 105 Victoria Street, London, SW1E 6QT, UK.
- Department of Medical Statistics, RWTH-Aachen University, Universitätsklinikum Aachen, Pauwelsstraße 30, 52074, Aachen, Germany.
- SYNAPSE Research Management Partners, Diputació 237, Àtic 3ª, 08007, Barcelona, Spain.
- Department of Infection, Immunity and Cardiovascular Disease and Insigneo Institute for In-Silico Medicine, Medical School, University of Sheffield, Beech Hill Road, Sheffield, S10 2RX, UK.
- Department of Statistics, School of Mathematics, University of Leeds, Leeds, LS2 9JT, UK.
- Department of Medical & Molecular Genetics, King's College London, London, SE1 9RT, UK.
- Genomics England, London, EC1M 6BQ, UK.
- National and Kapodistrian University of Athens, Medical School, Xristou Lada 6, 10561, Athens, Greece.
- Vitromics Healthcare Holding B.V., Onderwijsboulevard 225, 5223 DE, 's-Hertogenbosch, The Netherlands.
- Fraunhofer Institute for Molecular Biology and Applied Ecology ScreeningPort, Schnackenburgallee 114, 22525, Hamburg, Germany.
- ITTM S.A., 9 avenue des Hauts Fourneaux, 4362, Esch-sur-Alzette, Luxembourg.
- Research Business Technology, Pfizer Ltd, GP4 Building, Granta Park, Cambridge, CB21 6GP, UK.
- Health Economics & Outcomes Research, Deloitte Belgium, Berkenlaan 8A, 1831, Diegem, Belgium.
- Janssen Pharmaceutica N.V., R&D G3O, Turnhoutseweg 30, 2340, Beerse, Belgium.
- Faculty of Life Sciences, University of Manchester, AV Hill Building, Oxford Road, Manchester, M13 9PT, UK.
- UMR3664 IC/CNRS, Institut Curie, Section Recherche, Pavillon Pasteur, 26 rue d'Ulm, 75248, Paris cedex 05, France.
- Linguamatics Ltd, 324 Cambridge Science Park Milton Rd, Cambridge, CB4 0WG, UK.
- PwC Luxembourg, 2 rue Gerhard Mercator, 2182, Luxembourg, Luxembourg.
- Philips, HighTechCampus 36, 5656AE, Eindhoven, The Netherlands.
- Department of Public Health and Primary Care, KU Leuven Kulak, Etienne Sabbelaan 53, 8500, Kortrijk, Belgium.
- INCLIVA Health Research Institute, University of Valencia, CIBERobn ISCIII,Avenida Menéndez Pelayo 4 accesorio, 46010, Valencia, Spain.
- Luxembourg Centre for Systems Biomedicine, University of Luxembourg, 7 Avenue des Hauts Fourneaux, 4362, Esch-sur-Alzette, Luxembourg.
- Swiss Institute of Bioinformatics (SIB) and University of Basel, Klingelbergstrasse 50/70, 4056, Basel, Switzerland.
- Agency for Health Quality and Assessment of Catalonia (AQuAS), Carrer de Roc Boronat 81-95, 08005, Barcelona, Spain.
- EuroBioForum Foundation, Chrysantstraat 10, 3135 HG, Vlaardingen, The Netherlands.
- Integrated BioBank of Luxembourg, 6 rue Nicolas-Ernest Barblé, 1210,Luxembourg, Luxembourg.
- Technopolis Group, 3 Pavilion Buildings, Brighton, BN1 1EE, UK.
- Hospital Clinic of Barcelona, Institute d'Investigacions Biomediques August Pi Sunyer (IDIBAPS), Rosello 149, 08036, Barcelona, Spain.
- European Platform for Patients' Organisations, Science and Industry (Epposi), De Meeûs Square 38-40, 1000, Brussels, Belgium.
- CRS4, Ed.1 POLARIS, 09129, Pula, Italy.
- BBMRI-ERIC, Neue Stiftingtalstrasse 2/B/6, 8010, Graz, Austria.
Erratum in Genome Med. 2016 Nov 7;8(1):118.
Medicine and healthcare are undergoing profound changes. Whole-genome sequencing and high-resolution imaging technologies are key drivers of this rapid and crucial transformation. Technological innovation combined with automation and miniaturization has triggered an explosion in data production that will soon
reach exabyte proportions. How are we going to deal with this exponential increase in data production? The potential of "big data" for improving health is enormous but, at the same time, we face a wide range of challenges to overcome urgently. Europe is very proud of its cultural diversity; however, exploitation of the data made available through advances in genomic medicine, imaging, and a wide range of mobile health applications or connected devices is hampered by numerous historical, technical, legal, and political barriers. European health systems and databases are diverse and fragmented. There is a lack of harmonization of data formats, processing, analysis, and data transfer, which leads to incompatibilities and lost opportunities. Legal frameworks for data sharing are evolving. Clinicians, researchers, and citizens need improved methods, tools, and training to generate, analyze, and query data effectively.
Addressing these barriers will contribute to creating the European Single Market for health, which will improve health and healthcare for all Europeans.
8. Review - Aging Clin Exp Res . 2017 Feb;29(1):49-57. doi: 10.1007/s40520-016-0711-6. Epub 2017 Feb 11.
Possibilities of ICT-supported services in the clinical management of older adults
Miriam Vollenbroek-Hutten 1 2 3 , Stephanie Jansen-Kosterink 4 , Monique Tabak 4 5 , Luca Carlo Feletti 6 , Gianluca Zia 6 , Aurèle N'dja 7 , Hermie Hermens 4 5 , SPRINTT Consortium
Affiliations
- 1 Roessingh Research and Development, Telemedicine group, Enschede, The Netherlands.
This email address is being protected from spambots. You need JavaScript enabled to view it. . - 2 Faculty of Electrical Engineering, Mathematics and Computer Science, Telemedicine group, University of Twente, Enschede, The Netherlands.
This email address is being protected from spambots. You need JavaScript enabled to view it. . - 3 Ziekenhuis Groep Twente, Almelo, The Netherlands.
This email address is being protected from spambots. You need JavaScript enabled to view it. . - 4 Roessingh Research and Development, Telemedicine group, Enschede, The Netherlands.
- 5 Faculty of Electrical Engineering, Mathematics and Computer Science, Telemedicine group, University of Twente, Enschede, The Netherlands.
- 6 Caretek, Turin, Italy.
- 7 Sanofi R&D, Chilly Mazarin, France.
- PMID: 28190149 - PMCID: PMC5343081 - DOI: 10.1007/s40520-016-0711-6
Abstract
Services making use of information and communication technology (ICT) are of potential interest to face the challenges of our aging society. Aim of this article is to describe the possible field of application for ICT-supported services in the management of older adults, in particular those with functional impairment. The current status of ICT-supported services is described and examples of how these services can be implemented in everyday practice are given. Upcoming technical solutions and future directions are also addressed. An ICT-supported service is not only the technological tool, but its combination with clinical purposes for which it is used and the way it is implemented in everyday care. Patient's satisfaction with ICT-supported services is moderate to good. Actual use of patients is higher than those of professionals but very variable. Frequency of use is positively related to clinical outcome. ICT offers a variety of opportunities for the treatment and prevention of frailty and functional decline. Future challenges are related to the intelligence of the systems and making the technologies even more unobtrusive and intuitive.
9. Clinical Trial Exp Gerontol - . 2018 Nov;113:48-57. doi: 10.1016/j.exger.2018.09.017. Epub 2018 Sep 24.
The "Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies" (SPRINTT) randomized controlled trial: Case finding, screening and characteristics of eligible participants
Emanuele Marzetti 1 , Matteo Cesari 2 , Riccardo Calvani 3 , Jérôme Msihid 4 , Matteo Tosato 1 , Leocadio Rodriguez-Mañas 5 , Fabrizia Lattanzio 6 , Antonio Cherubini 7 , Raphaël Bejuit 4 , Mauro Di Bari 8 , Marcello Maggio 9 , Bruno Vellas 10 , Thierry Dantoine 11 , Alfonso J Cruz-Jentoft 12 , Cornel C Sieber 13 , Ellen Freiberger 13 , Anna Skalska 14 , Tomasz Grodzicki 14 , Alan J Sinclair 15 , Eva Topinkova 16 , Ingrid Rýznarová 17 , Timo Strandberg 18 , Annemie M W J Schols 19 , Jos M G A Schols 20 , Regina Roller-Wirnsberger 21 , Pálmi V Jónsson 22 , Alfons Ramel 22 , Susanna Del Signore 23 , Marco Pahor 24 , Ronenn Roubenoff 25 , Roberto Bernabei 1 , Francesco Landi 1 , SPRINTT Consortium
Affiliations
Affiliations
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
- Department of Clinical Sciences and Community Health, University of Milan, Italy; Geriatric Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address:
This email address is being protected from spambots. You need JavaScript enabled to view it. . - Sanofi R&D, Chilly-Mazarin, Paris, France.
- Service of Geriatrics, Getafe University Hospital, Madrid, Spain.
- Scientific Direction, IRCCS INRCA, Ancona, Italy.
- Geriatria, Accettazione Geriatrica e Centro di Ricerca per l'Invecchiamento, IRCCS INRCA, Ancona, Italy.
- Research Unit of Medicine of Aging, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Division of Geriatric Cardiology and Medicine, Department of Geriatrics and Medicine, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
- Department of Geriatric Rehabilitation, University Hospital of Parma, Parma, Italy; Department of Medicine and Surgery, University of Parma, Parma, Italy.
- Gérontopôle, University Hospital of Toulouse, Toulouse, France.
- University Hospital of Limoges, Limoges, France.
- Servicio de Geriatría, Hospital Universitario Ramón y Cajal (IRYCIS), Madrid, Spain.
- Institute for Biomedicine of Aging, Friedrich-Alexander-University, Nuremberg, Germany.
- Department of Internal Medicine and Gerontology, Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland.
- Foundation for Diabetes Research in Older People, Diabetes Frail Limited, Worcestershire, UK.
- Department of Geriatrics, First Faculty of Medicine, Charles University, Prague, Czech Republic.
- Geriatric Department, Silesians Hospital, Opava, Czech Republic.
- University of Helsinki, Clinicum, Helsinki, Finland; Helsinki University Hospital, Medicine and Rehabilitation, Helsinki, Finland; University of Oulu, Center for Life Course Health Research, Oulu, Finland.
- Department of Respiratory Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Center, Maastricht, the Netherlands.
- Department of Health Services Research, Maastricht University Medical Center, Maastricht, the Netherlands.
- Department of Internal Medicine, Medical University of Graz, Graz, Austria.
- Department of Geriatrics, Faculty of Medicine, Landspitali University Hospital, University of Iceland, Reykjavik, Iceland.
- BlueCompanion Ltd., London, UK; Biophytis, Paris, France.
- Department of Aging and Geriatric Research, Institute on Aging, University of Florida, Gainesville, FL, USA.
- Translational Medicine, Novartis Institutes for Biomedical Research, Basel, Switzerland.
PMID: 30261246 - DOI: 10.1016/j.exger.2018.09.017
Abstract
Background: The ongoing "Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies (SPRINTT)" randomized controlled trial (RCT) is testing the efficacy of a multicomponent intervention in the prevention of mobility disability in older adults with physical frailty & sarcopenia (PF&S). Here, we describe the procedures followed for PF&S case finding and screening of candidate participants for the SPRINTT RCT. We also illustrate the main demographic and clinical characteristics of eligible screenees.
Methods: The identification of PF&S was based on the co-occurrence of three defining elements: (1) reduced physical performance (defined as a score on the Short Physical Performance Battery between 3 and 9); (2) low muscle mass according to the criteria released by the Foundation for the National Institutes of Health; and (3) absence of mobility disability (defined as ability to complete the 400-m walk test in 15 min). SPRINTT was advertised through a variety of means. Site-specific case finding strategies were developed to accommodate the variability across centers in catchment area characteristics and access to the target population. A quick "participant profiling" questionnaire was devised to facilitate PF&S case finding.
Results: During approximately 22 months, 12,358 prescreening interviews were completed in 17 SPRINTT sites resulting in 6710 clinic screening visits. Eventually, 1566 candidates were found to be eligible for participating in the SPRINTT RCT. Eligible screenees showed substantial physical function impairment and comorbidity burden. In most centers, project advertisement through mass media was the most rewarding case finding strategy.
Conclusion: PF&S case finding in the community is a challenging, but feasible task. Although largely autonomous in daily life activities, older adults with PF&S suffer from significant functional impairment and comorbidity. This subset of the older population is therefore at high risk for disability and other negative health-related events. Key strategies to consider for successfully intercepting at-risk older adults should focus on mass communication methods.
Keywords: Functional impairment; Mobility disability; Physical performance; Prevention; Recruitment; Skeletal muscle.
10. Vaccine. 2021 Apr 22;39(17):2325-2327. doi: 10.1016/j.vaccine.2021.03.066. Epub 2021 Mar 22.
Are vaccines against COVID-19 tailored to the most vulnerable people?
Raffaele Antonelli Incalzi 1 , Caterina Trevisan 2 , Susanna Del Signore 3 , Stefano Volpato 4 , Stefano Fumagalli 5 , Fabio Monzani 6 , Giuseppe Bellelli 7 , Pietro Gareri 8 , Enrico Mossello 5 , Alba Malara 9 , Alessandra Coin 10 , Gianluca Zia 3 , Anette Hylen Ranhoff 11
Affiliations
PMID: 33810907 - PMCID: PMC7983447 - DOI: 10.1016/j.vaccine.2021.03.066
Abstract
The rapidly growing evidence that different vaccines are effective against coronavirus disease 2019 (COVID-19) arouses hope that most of at-risk population will be immunized within the current year. Despite the well-known age-related immunological changes [1], trials’ results suggest that COVID-19 vaccines might achieve comparable efficacy in younger and older adults, the latter being the most vulnerable to the disease.
About recommended inclusion criteria that make Clinical Trials results applicable to the general population, the ICH E7 2009 Q&A revision [2] reaffirms the need for a meaningful representation of age classes over 65 years, and particularly those over 75 years. Ideally, the age distribution in the tested population should mirror the incidence of the target disease in the general population. Increased attention to involving older adults in confirmatory clinical trials has been paid in the last decade, including initiatives to develop adapted formulations e.g. a high-dose anti-flu vaccine by Sanofi [3], not made available in the EU.
Keywords: COVID-19; Frailty; Older people; Vaccines.
11 . Observational Study - Eur J Intern Med 2021 May;87:29-35. doi: 10.1016/j.ejim.2021.01.017. Epub 2021 Jan 31.
Assessing the impact of COVID-19 on the health of geriatric patients: The European GeroCovid Observational Study
Caterina Trevisan 1 , Susanna Del Signore 2 , Stefano Fumagalli 3 , Pietro Gareri 4 , Alba Malara 5 , Enrico Mossello 3 , Stefano Volpato 6 , Fabio Monzani 7 , Alessandra Coin 8 , Giuseppe Bellelli 9 , Gianluca Zia 2 , Anette Hylen Ranhoff 10 , Raffaele Antonelli Incalzi 11 , GeroCovid Working Group
Affiliations
PMID: 33573885 - PMCID: PMC7847394 - DOI: 10.1016/j.ejim.2021.01.017
Abstract
Background: Despite the growing evidence on COVID-19, there are still many gaps in the understanding of this disease, especially in individuals in advanced age. We describe the study protocol of GeroCovid Observational, a multi-purpose, multi-setting and multicenter initiative that aims at investigating: risk factors, clinical presentation and outcomes of individuals affected by COVID-19 in acute and residential care settings; best strategies to prevent infection in long-term care facilities; and, impact of the pandemic on neuropsychologic, functional and physical health, and on medical management in outpatients and home care patients at risk of COVID-19, with a special focus on individuals with dementia.
Methods: GeroCovid involves individuals aged ≥60 years, at risk of or affected by COVID-19, prospectively or retrospectively observed since March 1st, 2020. Data are collected in multiple investigational sites across Italy, Spain and Norway, and recorded in a de-identified clinical e-Registry. A common framework was adapted to different care settings: acute wards, long-term care facilities, geriatric outpatient and home care, and outpatient memory clinics.
Results: At September 16th, 2020, 66 investigational sites obtained their Ethical Committee approval and 1618 cases (mean age 80.6 [SD=9.0] years; 45% men) have been recorded in the e-Registry. The average inclusion rate since the study start on April 25th, 2020, is 11.2 patients/day. New cases enrollment will ended on December 31st , 2020, and the clinical follow-up will end on June 30th, 2021.
Conclusion: GeroCovid will explore relevant aspects of COVID-19 in adults aged ≥60 years with high-quality and comprehensive data, which will help to optimize COVID-19 prevention and management, with practical implications for ongoing and possible future pandemics.
Trial registration: NCT04379440 (clinicaltrial.gov).
Keywords: COVID-19; Health Services for the Aged; Inpatients; Nursing Homes; Observational Study; Outpatients.
Copyright © 2021. Published by Elsevier B.V.
12 . Front Med (Lausanne) - 2021 Sep 22;8:715294. doi: 10.3389/fmed.2021.715294. eCollection 2021.
Psychological Well-Being of Older Adults With Cognitive Deterioration During Quarantine: Preliminary Results From the GeroCovid Initiative
Alessandra Coin 1 , Maria Devita 2 , Caterina Trevisan 1 , Francesca Biasin 1 , Camilla Terziotti 1 , Susanna Del Signore 3 , Stefano Fumagalli 4 , Pietro Gareri 5 , Alba Malara 6 , Enrico Mossello 4 , Stefano Volpato 7 , Fabio Monzani 8 , Giuseppe Bellelli 9 , Gianluca Zia 3 , Anette Hylen Ranhoff 10 , Raffaele Antonelli Incalzi 11
Affiliations
- Geriatrics Division, Department of Medicine (DIMED), Azienda Ospedale Università di Padova, University of Padova, Padua, Italy.
- Department of General Psychology (DPG), University of Padova, Padua, Italy.
- Bluecompanion Ltd, London, United Kingdom.
- Geriatric Intensive Care Unit, Department of Experimental and Clinical Medicine, University of Firenze, Firenze, Italy.
- Center for Cognitive Disorders and Dementia - Catanzaro Lido, ASP Catanzaro, Catanzaro, Italy.
- Scientific Committee of National Association of Third Age Residences (ANASTE) Calabria, Lamezia Terme, Italy.
- Department of Medical Science, University of Ferrara, Ferrara, Italy.
- Geriatrics Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
- Acute Geriatric Unit, School of Medicine and Surgery, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy.
- Department of Clinical Science, Norway and Diakonhjemmet Hospital, University of Bergen, Oslo, Norway.
PMID: 34631737 - PMCID: PMC8493282 - DOI: 10.3389/fmed.2021.715294
Abstract
Objectives: The spread of COVID-19 has undeniably unsettled the social, psychological and emotional life of the entire world population. Particular attention should be paid to older adults with dementia, given their vulnerability to emotional stressors. The aim of this retrospective study is to evaluate the impact of the first wave quarantine related to Covid-19 on psychological and affective well-being of older adults with mild/major neurocognitive disorders and of their caregivers. Methods: Data on participants' assessment before the quarantine (PREQ) were retrospectively collected. Patients with Mild Cognitive Impairment (MCI) or dementia were recruited from different Centers for Cognitive Decline and Dementia in Italy. During the quarantine, psychological and affective well-being were evaluated by phone through the administrations of scales measuring anxiety and depression (DASS), perceived stress (PSS), coping strategies (COPE) and the caregivers' burden (CBI). The scales' results were compared across participants' PREQ cognitive level (Mini Mental State Examination, MMSE ≥25, 23-24, and ≤ 22) with multiple linear regression models. Results: The sample included 168 patients (64% women) with a mean age of 79 ± 7 years. After adjusting for potential confounders, more severe cognitive impairment was independently associated with higher DASS and PSS score, and poorer coping strategies (p < 0.05). Cognitive functioning was also inversely associated with CBI. Conclusions: The impact of the quarantine on the psycho-affective well-being of individuals with MCI and dementia and on caregivers' burden varies according to the PREQ cognitive functioning with more severely impaired patients having worse outcomes.
Keywords: COVID-19; dementia; distress; older adults; psychological well-being.
Copyright © 2021 Coin, Devita, Trevisan, Biasin, Terziotti, Signore, Fumagalli, Gareri, Malara, Mossello, Volpato, Monzani, Bellelli, Zia, Ranhoff and Antonelli Incalzi.
13. Observational Study - Thromb Haemost . 2022 Jan;122(1):105-112. doi: 10.1055/a-1503-3875. Epub 2021 Jun 18.
COVID-19 and Atrial Fibrillation in Older Patients: Does Oral Anticoagulant Therapy Provide a Survival Benefit?-An Insight from the GeroCovid Registry
Stefano Fumagalli 1 , Caterina Trevisan 2 , Susanna Del Signore 3 , Giulia Pelagalli 1 , Stefano Volpato 4 , Pietro Gareri 5 , Enrico Mossello 1 , Alba Malara 6 , Fabio Monzani 7 , Alessandra Coin 2 , Giuseppe Bellelli 8 , Gianluca Zia 3 , Raffaele Antonelli Incalzi 9 , GeroCovid Working Group
Affiliations
- Geriatric Intensive Care Unit and Geriatric Arrhythmia Unit, Department of Experimental and Clinical Medicine, University of Florence and AOU Careggi, Florence, Italy.
- Geriatrics Division, Department of Medicine (DIMED), University of Padua, Padua, Italy.
- Bluecompanion ltd, London, United Kingdom.
- Section of Internal and Cardiorespiratory Medicine, Department of Medical Science, University of Ferrara, Ferrara, Italy.
- Center for Cognitive Disorders and Dementia - Catanzaro Lido, ASP Catanzaro, Catanzaro, Italy.
- Scientific Committee of National Association of Third Age Residences (ANASTE) Calabria, Lamezia Terme (Catanzaro), Catanzaro, Italy.
- Geriatrics Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
- Acute Geriatric Unit, San Gerardo Hospital, School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.
- Unit of Geriatrics, Department of Medicine, Campus Bio Medico University and Teaching Hospital, Rome, Italy.
PMID: 33962480 - DOI: 10.1055/a-1503-3875
Abstract
Introduction: Atrial fibrillation (AF), the most frequent arrhythmia of older patients, associates with serious thromboembolic complications and high mortality. Coronavirus disease 2019 (COVID-19) severely affects aged subjects, determining an important prothrombotic status. The aim of this study was to evaluate mortality-related factors in older AF patients with COVID-19.
Methods: Between March and June 2020, we enrolled ≥60 year-old in-hospital COVID-19 patients (n = 806) in GeroCovid, a multicenter observational study promoted by the Italian Society of Gerontology and Geriatric Medicine.
Results: The prevalence of AF was 21.8%. In-hospital mortality was higher in the AF group (36.9 vs. 27.5%, p = 0.015). At admission, 51.7, 10.2, and 38.1% of AF cases were taking, respectively, oral anticoagulants (OACs), antiplatelet agents, and no antithrombotic therapy. During hospitalization, 51% patients switched to low-molecular-weight heparins. AF patients who survived were younger (81 ± 8 vs. 84 ± 7 years; p = 0.002) and had a lower CHA2DS2-VASc score (3.9 ± 1.6 vs. 4.4 ± 1.3; p = 0.02) than those who died. OAC use before (63.1 vs. 32.3%; p < 0.001) and during hospitalization (34.0 vs. 12.7%; p = 0.002) was higher among survivors. At multivariable analysis, lower age, higher self-sufficiency, less severe initial COVID-19 presentation, and the use of vitamin K antagonists (odds ratio [OR] = 0.16, 95% confidence interval [CI]: 0.03-0.84) or direct OACs (OR = 0.22, 95% CI: 0.08-0.56) at admission, or the persistence of OAC during hospitalization (OR = 0.05, 95% CI: 0.01-0.24), were associated with a lower chance of in-hospital death.
Conclusion: AF is a prevalent and severe condition in older COVID-19 patients. Advanced age, dependency, and relevant clinical manifestations of disease characterized a worse prognosis. Preadmission and in-hospital anticoagulant therapies were positively associated with survival.
Thieme. All rights reserved.
14. Gerontology 2022;68(4):412-417.doi: 10.1159/000516969. Epub 2021 Jun 28.
Management of Older Outpatients during the COVID-19 Pandemic: The GeroCovid Ambulatory Study
Pietro Gareri 1 , Stefano Fumagalli 2 , Alba Malara 3 , Enrico Mossello 2 , Caterina Trevisan 4 , Stefano Volpato 5 , Alessandra Coin 2 , Valeria Calsolaro 6 , Giuseppe Bellelli 7 , Susanna Del Signore 8 , Gianluca Zia 8 , Anette Hylen Ranhoff 9 , Raffaele Antonelli Incalzi 10 , GeroCovid Ambulatory Study Group
Affiliations
Affiliations
- CDCD Catanzaro Lido - ASP Catanzaro, Catanzaro, Italy.
- Department of Experimental and Clinical Medicine, University of Florence and SOD Geriatrics-UTIG, AOU Careggi, Florence, Italy.
- Scientific Committee of National Association of Third Age Residences (ANASTE) Calabria, Lamezia Terme, Italy.
- Geriatrics Division, Department of Medicine (DIMED), University of Padua, Padua, Italy.
- Department of Medical Science, University of Ferrara, Ferrara, Italy.
- Geriatrics Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
- School of Medicine and Surgery, University of Milano-Bicocca and Acute Geriatic Unit, San Gerardo Hospital, Monza, Italy.
- Blue Companion Ltd, London, United Kingdom.
- Department of Clinical Science, University of Bergen, Norway and Diakonhjemmet Hospital, Oslo, Norway.
- Unit of Geriatrics, Department of Medicine, Campus Bio-Medico University and Teaching Hospital, Rome, Italy.
PMID: 34182557 - PMCID: PMC8339050 - DOI: 10.1159/000516969
Free PMC article
Abstract
Objectives: The GeroCovid Study is a multi-setting, multinational, and multi-scope registry that includes the GeroCovid home and outpatients' care cohort. The present study aims to evaluate whether outpatient and home care services with remote monitoring and consultation could mitigate the impact of the COVID-19 pandemic on mental and affective status, perceived well-being, and personal capabilities of outpatients and home care patients with cognitive disorders.
Methods: Prospectively recorded patients in an electronic web registry provided by BlueCompanion Ltd. Up to October 31, 2020, the sample included 90 patients receiving regular care from the Center for Cognitive Disorders and Dementia in Catanzaro Lido, Italy. It was made of 52 ambulatory outpatients and 38 home care patients, mean age 83.3 ± 7.54 years. Participants underwent a multidimensional assessment at baseline (T0) and after 90 days (T1). For each patient, we administered the Mini-Mental State Examination (MMSE) for cognitive functions, the Activities of Daily Living (ADL) and Instrumental ADL (IADL) scales for functional capabilities, the Cumulative Illness Rating Scale (CIRS) for comorbidities and their impact on patients' health, the 5-items Geriatric Depression Scale (GDS) for mood, and the Euro Quality of Life (EuroQoL) for perceived quality of life. Contacts with both ambulatory and home care patients were managed in person or via telephone, preferably through video calls (WhatsApp or FaceTime).
Results: Contacts with patients were kept at T0 through telephone. At T1, visits were made in person for over 95% out of the cases. The ADL, IADL, CIRS, GDS, MMSE, and EuroQoL changed slightly between T0 and T1. Most of the patients were clinically stable over time on the majority of the scales explored, but behavioral changes were found in 24.4% of patients and anxiety and insomnia in 17.7% of patients.
Conclusion: Our study suggests that contacts through telephone and video consultations are likely associated with a health status preservation of the patients.
Keywords: COVID-19; GeroCovid study; Home care patients; Older patients; Outpatients.
© 2021 S. Karger AG, Basel.
15. Multicenter Study Aging Clin Exp Res - 2022 Jan;34(1):249-256.doi: 10.1007/s40520-021-02008-5. Epub 2021 Oct 30.
Atrial fibrillation and COVID-19 in older patients: how disability contributes to shape the risk profile. An analysis of the GeroCovid registry
Stefano Fumagalli 1 , Caterina Trevisan 2 , Susanna Del Signore 3 , Giulia Pelagalli 4 , Carlo Fumagalli 4 , Andrea Herbst 4 , Stefano Volpato 5 , Pietro Gareri 6 , Enrico Mossello 4 , Alba Malara 7 , Fabio Monzani 8 , Chukwuma Okoye 8 , Alessandra Coin 2 , Giuseppe Bellelli 9 , Gianluca Zia 3 , Andrea Ungar 4 , Anette Hylen Ranhoff 10 , Raffaele Antonelli Incalzi 11 , GeroCovid Working Group
Affiliations
Affiliations
- Geriatric Intensive Care Unit and Geriatric Arrhythmia Unit, Department of Experimental and Clinical Medicine, University of Florence and AOU Careggi, Largo Brambilla, 3, 50134, Florence, Italy.
This email address is being protected from spambots. You need JavaScript enabled to view it. . - Geriatrics Division, Department of Medicine (DIMED), University of Padua, Padua, Italy.
- Bluecompanion Ltd, London, UK.
- Geriatric Intensive Care Unit and Geriatric Arrhythmia Unit, Department of Experimental and Clinical Medicine, University of Florence and AOU Careggi, Largo Brambilla, 3, 50134, Florence, Italy.
- Department of Medical Science, Section of Internal and Cardiorespiratory Medicine, University of Ferrara, Ferrara, Italy.
- Center for Cognitive Disorders and Dementia-Catanzaro Lido, ASP Catanzaro, Catanzaro, Italy.
- Scientific Committee of National Association of Third Age Residences (ANASTE) Calabria, Lamezia Terme (Catanzaro), Italy.
- Geriatrics Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
- School of Medicine and Surgery, Acute Geriatric Unit, University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy.
- Department of Clinical Science, University of Bergen, Bergen, Norway.
- Unit of Geriatrics, Department of Medicine, Campus Bio Medico University and Teaching Hospital, Rome, Italy
PMID: 34716570 - PMCID: PMC8556143 - DOI: 10.1007/s40520-021-02008-5
Abstract
Background and aims: Atrial fibrillation (AF) is often complicated by disabling conditions in the elderly. COVID-19 has high mortality in older people. This study aimed at evaluating the relationship of pre-infection AF with characteristics and survival of older COVID-19 patients.
Methods: We retrospectively analyzed inpatients aged ≥ 60 years enrolled in GeroCovid Observational, a multicenter registry endorsed by the Italian and the Norwegian Societies of Gerontology and Geriatrics. Pre-COVID-19 sociodemographic, functional, and medical data were systematically collected, as well as in-hospital mortality.
Results: Between March and June 2020, 808 COVID-19 subjects were enrolled (age 79 ± 9 years; men 51.7%). The prevalence of AF was 21.8%. AF patients were older (82 ± 8 vs. 77 ± 9 years, p < 0.001), had a higher CHA2DS2-VASc score (4.1 ± 1.5 vs. 3.2 ± 1.5, p < 0.001) and were more likely to present almost all comorbidities. At multivariable analysis, advanced age, white blood cell count, the presence of heart and peripheral artery diseases were significantly associated with the presence of AF. In-hospital mortality was higher in AF patients (36.9 vs. 27.5%; OR = 1.55, 95% CI = 1.09-2.20; p = 0.015). A decision tree analysis showed that, in AF subjects, preserved functional status at admission was the most important factor associated with survival. In patients without AF, baseline COVID-19 severity was the most relevant variable related to clinical prognosis.
Conclusions: AF is frequent in older patients with COVID-19, in whom it associates with clinical complexity and high mortality. Pre-infection disability shapes the prognosis of this extremely vulnerable segment of hospitalized subjects.
Clinical trial registration: GeroCovid Observational was registered at www.clinicaltrials.gov (NCT04379440).
Keywords: Atrial fibrillation; COVID-19; Disability; Older patients; Oral anticoagulants; Prognosis.
© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
16. Observational Study - J Am Med Dir Assoc . 2022 Jan;23(1):15-18. doi: 10.1016/j.jamda.2021.10.009. Epub 2021 Oct 23.
Clinical Features of SARS-CoV-2 Infection in Italian Long-Term Care Facilities: GeroCovid LTCFs Observational Study
Alba Malara 1 , Marianna Noale 2 , Angela Marie Abbatecola 3 , Gilda Borselli 4 , Carmine Cafariello 5 , Stefano Fumagalli 6 , Pietro Gareri 7 , Enrico Mossello 6 , Caterina Trevisan 8 , Stefano Volpato 9 , Fabio Monzani 10 , Alessandra Coin 11 , Giuseppe Bellelli 12 , Chukwuma Okoye 10 , Susanna Del Signore 13 , Gianluca Zia 13 , Raffaele Antonelli Incalzi 14 , GeroCovid LTCFs Working Group
Collaborators
- GeroCovid LTCFs Working Group:
Angela Marie Abbatecola, Francesco Raffaele Addamo, Domenico Andrieri, Rachele Antognoli, Paola Bianchi, Carmine Cafariello, Valeria Calsolaro, Francesco Antonio Campagna, Sebastiano Capurso, Silvia Carino, Manuela Castelli, Arcangelo Ceretti, Mauro Colombo, Antonella Crispino, Roberta Cucunato, Ferdinando D'Amico, Annalaura Dell'Armi, Christian Ferro, Serafina Fiorillo, Pier Paolo Gasbarri, Roberta Granata, Nadia Grillo, Antonio Guaita, Marilena Iarrera, Valerio Alex Ippolito, Alba Malara, Irene Mancuso, Eleonora Marelli, Paolo Moneti, Fabio Monzani, Marianna Noale, Sara Osso, Agostino Perri, Maria Perticone, Carmine Romaniello, Marcello Russo, Giovanni SgrÃ, Federica Sirianni, Deborah Spaccaferro, Fausto Spadea, Rita Ursino
Affiliations
- ANASTE-Humanitas Foundation, Rome, Italy. Electronic address:
This email address is being protected from spambots. You need JavaScript enabled to view it. . - Aging Branch, Neuroscience Institute, National Research Council, Padua, Italy.
- Alzheimer's Disease Clinic Department, Azienda Sanitaria Locale (ASL) Frosinone, Italy.
- Italian Society of Gerontology and Geriatrics (SIGG), Florence, Italy.
- Geriatrics Outpatient Clinic and Territorial Residences, Italian Hospital Group, Rome, Italy.
- Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Division of Geriatric and Intensive Care Medicine, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
- Center for Cognitive Disorders and Dementia (CDCD) Catanzaro Lido - ASP Catanzaro, Italy.
- Azienda Ospedaliero-Universitaria, Geriatrics Division, Department of Medicine (DIMED), University of Padua, Italy; Department of Medical Science, University of Ferrara, Italy.
- Department of Medical Science, University of Ferrara, Italy.
- Geriatrics Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.
- Azienda Ospedaliero-Universitaria, Geriatrics Division, Department of Medicine (DIMED), University of Padua, Italy.
- School of Medicine and Surgery, University of Milano-Bicocca and Acute Geriatric Unit, San Gerardo Hospital, Monza, Italy.
- Bluecompanion Ltd, Londra, United Kingdom.
- Unit of Geriatrics, Department of Medicine, Campus Bio-Medico University and Teaching Hospital, Rome, Italy.
PMID: 34774494 PMCID: PMC8536727 DOI: 10.1016/j.jamda.2021.10.009
17. Multicenter Study BMC Geriatr 2022 Mar 1;22(1):166. doi: 10.1186/s12877-022-02837-7.
Computed tomography findings and prognosis in older COVID-19 patients
Chukwuma Okoye 1 , Panaiotis Finamore 2 , Giuseppe Bellelli 3 , Alessandra Coin 4 , Susanna Del Signore 5 , Stefano Fumagalli 6 , Pietro Gareri 7 , Alba Malara 8 , Enrico Mossello 6 , Caterina Trevisan 4 , Stefano Volpato 9 , Gianluca Zia 5 , Fabio Monzani 1 , Raffaele Antonelli Incalzi 10
Affiliations
- Geriatrics Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
- Geriatrics Unit, Department of Medicine, Campus Bio-Medico University and Teaching Hospital, Rome, Italy.
This email address is being protected from spambots. You need JavaScript enabled to view it. . - School of Medicine and Surgery, Acute Geriatric Unit, University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy.
- Geriatrics Unit and the GeroCovid Working Group, Department of Medicine (DIMED), University of Padua, Padua, Italy.
- Bluecompanion Ltd, London, UK, England.
- Geriatric Intensive Care Unit, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
- Center for Cognitive Disorders and Dementia - Catanzaro Lido, ASP Catanzaro, Italy.
- ANASTE Humanitas Foundation, Rome, Italy.
- Department of Medical Sciences, University of Ferrara, Ferrara, Italy.
- Geriatrics Unit, Department of Medicine, Campus Bio-Medico University and Teaching Hospital, Rome, Italy.
PMID: 35227201 PMCID: PMC8885320 DOI: 10.1186/s12877-022-02837-7
Abstract
Background: In older and multimorbid patients, chronic conditions may affect the prognostic validity of computed tomography (CT) findings in COVID-19. This study aims at assessing to which extent CT findings have prognostic implications in COVID-19 older patients.
Methods: Hospitalized COVID-19 patients aged 60 years or more enrolled in the multicenter, observational and longitudinal GeroCovid study who underwent chest CT were included. Patients were stratified by tertiles of age and pneumonia severity to compare CT findings. Hierarchical clustering based on CT findings was performed to identify CT-related classificatory constructs, if any. The hazard ratio (HR) of mortality was calculated for individual CT findings and for clusters, after adjusting for potential confounders.
Results: 380 hospitalized COVID-19 patients, with a mean age of 78 (SD:9) years, underwent chest CT scan. Ground glass opacity (GGO), consolidation, and pleural effusion were the three most common CT findings, with GGO prevalence decreasing from younger to older patients and pleural effusion increasing. More severe the pneumonia more prevalent were GGO, consolidation and pleural effusion. HR of mortality was 1.94 (95%CI 1.24-3.06) for pleural effusion and 13 (95%CI 6.41-27) for cluster with a low prevalence of GGO and a high prevalence of pleural effusion ("LH"), respectively. Out of the three CT based clusters, "LH" was the only independent predictor in the multivariable model.
Conclusions: Pleural effusion qualifies as a distinctive prognostic marker in older COVID-19 patients. Research is needed to verify whether pleural effusion reflects COVID-19 severity or a coexisting chronic condition making the patient at special risk of death.
Trial registration: ClinicalTrials.gov: NCT04379440.
Keywords: Old; Oldest; Pleural; SARS-CoV-2; Tomography; X-ray computed.
18. Vaccine . 2022 Apr 1;40(15):2324-2330. doi: 10.1016/j.vaccine.2022.02.064. Epub 2022 Feb 22.
Monitoring COVID-19 vaccine use in Italian long term care centers: The GeroCovid VAX study
Angela Marie Abbatecola 1 , Raffaele Antonelli Incalzi 2 , Alba Malara 3 , Annapina Palmieri 4 , Anna Di Lonardo 4 , Giorgio Fedele 5 , Paola Stefanelli 5 , Gilda Borselli 6 , Marcello Russo 7 , Marianna Noale 8 , Stefano Fumagalli 9 , Pietro Gareri 10 , Enrico Mossello 9 , Caterina Trevisan 11 , Stefano Volpato 12 , Fabio Monzani 13 , Alessandra Coin 14 , Giuseppe Bellelli 15 , Chukwuma Okoye 16 , Susanna Del Signore 17 , Gianluca Zia 17 , Elisa Bottoni 18 , Carmine Cafariello 19 , Graziano Onder 4 , GeroCovid Vax Working Group
Affiliations
- Azienda Sanitaria Locale (ASL) Alzheimer's Disease Day Clinic, Frosinone, Italy; Italian Society of Gerontology and Geriatrics (SIGG), Florence, Italy. Electronic address:
This email address is being protected from spambots. You need JavaScript enabled to view it. . - Italian Society of Gerontology and Geriatrics (SIGG), Florence, Italy; Unit of Geriatrics, Department of Medicine, Campus Bio-Medico University and Teaching Hospital, Rome, Italy.
- Italian Society of Gerontology and Geriatrics (SIGG), Florence, Italy; ANASTE-Humanitas Foundation, Rome, Italy.
- Department of Cardiovascular, Endocrine-Metabolic Diseases and Aging, Istituto Superiore di Sanità, Roma, Italy.
- Department of Infectious Diseases, Istituto Superiore di Sanità, Roma, Italy.
- Italian Society of Gerontology and Geriatrics (SIGG), Florence, Italy.
- Azienda Sanitaria Locale (ASL) Alzheimer's Disease Day Clinic, Frosinone, Italy.
- Aging Branch, Neuroscience Institute, National Research Council, Padua, Italy.
- Geriatric Intensive Care Unit, Department of Experimental and Clinical Medicine, University of Florence, Italy.
- Center for Cognitive Disorders and Dementia - Catanzaro Lido, ASP Catanzaro, Italy.
- Geriatrics Division, Department of Medicine (DIMED), University of Padua, Italy; Department of Medical Science, University of Ferrara, Italy.
- Italian Society of Gerontology and Geriatrics (SIGG), Florence, Italy; Department of Medical Science, University of Ferrara, Italy.
- Italian Society of Gerontology and Geriatrics (SIGG), Florence, Italy; Geriatrics Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.
- Geriatrics Division, Department of Medicine (DIMED), University of Padua, Italy.
- Italian Society of Gerontology and Geriatrics (SIGG), Florence, Italy; School of Medicine and Surgery, University of Milano-Bicocca and Acute Geriatric Unit, San Gerardo Hospital, Monza, Italy.
- Geriatrics Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.
- Bluecompanion Ltd, Londra, UK.
- Social Services Care, City Hall Cassino (FR), Italy.
- Geriatrics Outpatient Clinic and Territorial Residences, Italian Hospital Group, Rome, Italy.
- PMID: 35248424
Free PMC article
Abstract
The COVID-19 pandemic has changed routine care practice for older persons, especially in those with frailty living in long term care (LTC) facilities. Due to the high mortality rates of Nursing home (NH) residents during the first wave of the COVID-19 pandemic, priority for COVID-19 vaccinations was given to this vulnerable population. However, the safety and efficacy of such vaccines in older frail elders remains questionable due to the fact that initial randomized clinical trials (RCTs) for such vaccines did not include this population. This type of discrimination in patient participation in RCTs continues and has been recognized in the literature. Nevertheless, in the context of a worldwide emergency, COVID-19 vaccination in older persons living in LTC facilities may provide a solid basis to protect against negative outcomes, such as COVID-19 infection and death. In this report, we present the protocol of the GeroCovid Vax study, an Italian study that began in February 2021 which is aimed at investigating the safety and efficacy of the anti-SARS-CoV-2 vaccinations in older persons living in LTCs. This protocol specially aims to continuously and closely monitor events related to- and following- the anti-SARS-CoV-2 vaccination in elderly living in LTC facilities. In this report, we will provide information related to the study protocol and describe baseline characteristics of the sample.
Keywords: COVID-19 vaccine; Elderly; Frailty syndrome; GeroCovid Vax; Long term care (LTC); Nursing homes (NH); Safety.
Copyright © 2022 Elsevier Ltd. All rights reserved.
19. Randomized Controlled Trial - BMJ . 2022 May 11;377:e068788. doi: 10.1136/bmj-2021-068788.
Multicomponent intervention to prevent mobility disability in frail older adults: randomised controlled trial (SPRINTT project)
Roberto Bernabei 1 2 , Francesco Landi 1 2 , Riccardo Calvani 1 , Matteo Cesari 3 4 , Susanna Del Signore 5 , Stefan D Anker 6 , Raphael Bejuit 7 , Philippe Bordes 7 , Antonio Cherubini 8 , Alfonso J Cruz-Jentoft 9 , Mauro Di Bari 10 , Tim Friede 11 12 , Carmen Gorostiaga Ayestarán 13 , Harmonie Goyeau 7 , Pálmi V Jónsson 14 , Makoto Kashiwa 15 , Fabrizia Lattanzio 8 , Marcello Maggio 16 17 , Luca Mariotti 2 , Ram R Miller 18 , Leocadio Rodriguez-Mañas 19 , Regina Roller-Wirnsberger 20 , Ingrid Rýznarová 21 , Joachim Scholpp 22 , Annemie M W J Schols 23 , Cornel C Sieber 24 , Alan J Sinclair 25 , Anna Skalska 26 , Timo Strandberg 27 28 , Achille Tchalla 29 , Eva Topinková 30 , Matteo Tosato 1 , Bruno Vellas 31 , Stephan von Haehling 12 32 , Marco Pahor 33 , Ronenn Roubenoff 34 , Emanuele Marzetti 35 2 , SPRINTT consortium
Collaborators, Affiliations
Collaborators
- SPRINTT consortium:
Andeleeb Dahy, Laurent Nicolas, Gianluca Zia, Cinzia Bertuzzi, Sabina De Giorgi, Luca Feletti, Alessandro Loria, Davide Mantovani, Elisa Marchioro, Francesco Mocci, Alberto Sacco, Maria Grazia Varesio, Maxime Billot, Noëlle Cardinaud, Muriel Castelli, Marion Charenton-Blavignac, Cecilia Ciccolari-Micaldi, Thierry Dantoine, Caroline Gayot, Nicolas Giroult, Anael Larreur, Cécilie Laubarie-Mouret, Delphine Marchesseau, Thomas Mergans, Thai Binh Nguyen, Arnaud Papon, Johann Ribet, Isabelle Saulnie, Gabor Abellan Van Kan, Virginie Biville, Lauréane Brigitte, Carole Cervera, Céline Cluzan, Muriel Croizet, Sophie Dardenne, Marie Dorard, Charlotte Dupuy, Emilie Durand, Catherine Faisant, Sophie Guyonnet, Rémi Mauroux, Agathe Milhet, Sylvie Montel, Pierre-Jean Ousset, Cécile Picauron, Gaelle Soriano, Bernard Teysseyre, Sital Harris, Allison Ogborne, Sarah Ritchie, Harriet Sinclair, Lois Tirrell, Caroline Sinclair, Alfredo Cesario, Barbara Cabin, Pim de Boer, Claire Ignaszewski, Ingrid Klingmann, Tina Auerswald, Christof Engel, Anna Franke, Ellen Freiberger, Ulrike Freiheit, Susann Gotthardt, Karin Kampe, Robert Kob, Christine Kokott, Carolin Kraska, Christian Meyer, Veronika Reith, Hanna Rempe, Daniel Schoene, Gabrielle Sieber, Kerstin Zielinski, Nicole Ebner, Michael Benecky, Alejandro Alvarez-Bustos, Cristina Alonso Bouzon, Beatriz Contreras Escamez, Jimmy Gonzales Turin, Olga Laosa Zafra, Myriel Lopez Tatis, Laura Pedraza Sepulveda, Juan Luis Sanchez, Carlos Sanchez Puelles, Juan Álvarez-Santos, Belén Fernández-Jiménez, Jesús Mateos-Del Nozal, Beatriz Montero-Errasquín, Beatriz Ponce-Moreno, Cristina Roldán-Plaza, Alfonso Romera-de Vicente, Vicente Sánchez-Cadenas, Carmen Sánchez-Castellano, Elisabet Sánchez-García, María Nieves Vaquero-Pinto, Sandrine Andrieu, Alessandro Blasimme, Cedric Dray, Emmanuelle Rial-Sebbag, Philippe Valet, Laurence Laigle, Itziar Martinez-Melchor, Belen Surroca, Stefania Ambrosi, Renato Baldoni, Serena Bernabei, Anna Rita Bonfigli, Silvia Bustacchini, Barbara Carrieri, Anna Rita Costantini, Michela Cucchi, Giuseppina Dell'Aquila, Emma Espinosa, Luciano Izzo, Massimiliano Fedecostante, Michela Mannoni, Antonella Mengarelli, Marino Modestino, Emanuele Monterubbianesi, Stefano Piomboni, Antonia Scrimieri, Eddy Severini, Fabiana Mirella Trotta, Lorella Vece, Susanna Venere, Elisa Zengarini, Milan Chang, Hrafnhildur Eymundsdóttir, Ólöf Guðný Geirsdóttir, Steinn Baugur Gunnarsson, Steinunn Guðnadóttir, Alfons Ramel, Konstantín Shcherbak, Gerhard Wirnsberger, Sheena Kao, Romain Barnouin, Lex van Velsenm, Miriam Vollenbroek-Hutten, Christian Asbrand, Sandrine Durand, Florence Joly, Klaus Flechsenhar, Régis Le Lain, Jerome Mshihid, Aurèle Ndja, Ivana Drastichova, Eva Hasaliková, Radim Hucko, Seget Jakub, Monika Janácová, Michaela Kilmková, Martina Parízková, Kristyna Pavelková, Michaela Redrova, Petra Rusková, Michele Basile, Damiano Biscotti, Claudio Boni, Vincenzo Brandi, Marianna Broccatelli, Carilia Celesti, Americo Cicchetti, Hélio Jose Coelho-Junior, Agnese Collamati, Silvia Coretti, Emanuela D'Angelo, Mariaelena D'Elia, Eugenio Di Brino, Giovanni Landi, Anna Maria Martone, Elena Ortolani, Teodosio Pafundi, Cecilia Pantanelli, Anna Picca, Matteo Ruggeri, Filippo Rumi, Sara Salini, Giulia Savera, Elisabetta Serafini, Davide L Vetrano, Fabio Vitale, Elisa Adorni, Fulvio Lauretani, Yari Longobucco, Giovanna Maria Pelà, Sara Tagliaferri, Thomas Rapp, Yves Arrghi, Bastian Ravesteinj, Jérôme Ronchetti, Quittterie Roquebert, Jonathan Sicsic, Nicolas Sirven, Harry Gosker, Jos M G A Schols, Lisanne Schuurman, Nick Smeets, Coby van de Bool, Claire Weling, Katja Hallikas, Marjatta Herranen, Laura Hyvönen, Kirsi Ikonen, Satu Jyväkorpi, Anne Karppi-Sjöblom, Kaisa Karvinen, Tarja Kindstedt, Saana Leirimaa, Hanna Öhman, Kaisu Pitkälä, Anja Punkka, Anna-Maria Saavalainen, Tuulia Salo, Katja Sohlberg, Reijo Tilvis, Annele Urtamo, Hannu Vanhanen, Lucie Bautzká, Tereza Gueye, Ilona Juklíčková, Pavla Mádlová, Helena Mejstříková, Helena Michálková, Eva Klára Novotná, Tereza Vágnerová, Ewa Blaszczyk-Bebenek, Marcin Cwynar, Joanna Czesak, Paulina Fatyga, Malgorzata Fedyk-Lukasik, Tomasz Grodzicki, Paulina Jamrozik, Zbigniew Janusz, Ewa Klimek, Sylwia Komoniewska, Maria Kret, Maciej Ozog, Agnieszka Parnicka, Katarzyna Petitjean, Anna Pietrzyk, Karolina Piotrowicz, Barbara Skalska-Dulinska, Damian Starzyk, Katarzyna Szczerbinska, Borys Witkiewicz, Anna Wlodarczyk, Wieslawa Zgud
Affiliations
Free PMC article
Abstract
Objective: To determine whether a multicomponent intervention based on physical activity with technological support and nutritional counselling prevents mobility disability in older adults with physical frailty and sarcopenia.
Design: Evaluator blinded, randomised controlled trial.
Setting: 16 clinical sites across 11 European countries, January 2016 to 31 October 2019.
Participants: 1519 community dwelling men and women aged 70 years or older with physical frailty and sarcopenia, operationalised as the co-occurrence of low functional status, defined as a short physical performance battery (SPPB) score of 3 to 9, low appendicular lean mass, and ability to independently walk 400 m. 760 participants were randomised to a multicomponent intervention and 759 received education on healthy ageing (controls).
Interventions: The multicomponent intervention comprised moderate intensity physical activity twice weekly at a centre and up to four times weekly at home. Actimetry data were used to tailor the intervention. Participants also received personalised nutritional counselling. Control participants received education on healthy ageing once a month. Interventions and follow-up lasted for up to 36 months.
Main outcome measures: The primary outcome was mobility disability (inability to independently walk 400 m in <15 minutes). Persistent mobility disability (inability to walk 400 m on two consecutive occasions) and changes from baseline to 24 and 36 months in physical performance, muscle strength, and appendicular lean mass were analysed as pre-planned secondary outcomes. Primary comparisons were conducted in participants with baseline SPPB scores of 3-7 (n=1205). Those with SPPB scores of 8 or 9 (n=314) were analysed separately for exploratory purposes.
Results: Mean age of the 1519 participants (1088 women) was 78.9 (standard deviation 5.8) years. The average follow-up was 26.4 (SD 9.5) months. Among participants with SPPB scores of 3-7, mobility disability occurred in 283/605 (46.8%) assigned to the multicomponent intervention and 316/600 (52.7%) controls (hazard ratio 0.78, 95% confidence interval 0.67 to 0.92; P=0.005). Persistent mobility disability occurred in 127/605 (21.0%) participants assigned to the multicomponent intervention and 150/600 (25.0%) controls (0.79, 0.62 to 1.01; P=0.06). The between group difference in SPPB score was 0.8 points (95% confidence interval 0.5 to 1.1 points; P<0.001) and 1.0 point (95% confidence interval 0.5 to 1.6 points; P<0.001) in favour of the multicomponent intervention at 24 and 36 months, respectively. The decline in handgrip strength at 24 months was smaller in women assigned to the multicomponent intervention than to control (0.9 kg, 95% confidence interval 0.1 to 1.6 kg; P=0.028). Women in the multicomponent intervention arm lost 0.24 kg and 0.49 kg less appendicular lean mass than controls at 24 months (95% confidence interval 0.10 to 0.39 kg; P<0.001) and 36 months (0.26 to 0.73 kg; P<0.001), respectively. Serious adverse events occurred in 237/605 (39.2%) participants assigned to the multicomponent intervention and 216/600 (36.0%) controls (risk ratio 1.09, 95% confidence interval 0.94 to 1.26). In participants with SPPB scores of 8 or 9, mobility disability occurred in 46/155 (29.7%) in the multicomponent intervention and 38/159 (23.9%) controls (hazard ratio 1.25, 95% confidence interval 0.79 to 1.95; P=0.34).
Conclusions: A multicomponent intervention was associated with a reduction in the incidence of mobility disability in older adults with physical frailty and sarcopenia and SPPB scores of 3-7. Physical frailty and sarcopenia may be targeted to preserve mobility in vulnerable older people.
Trial registration: ClinicalTrials.gov NCT02582138.
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Conflict of interest statement
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: The present work was funded by a grant from the Innovative Medicines Initiative Joint Undertaking. AC, AJC-J, AJS, AMWJS, AS, AT, BV, CCS, EM, ET, FaL, FrL, IR, LM, LR-M, MC, MDB, MM, MT, PVJ, RB, RC, RR-W, SDA, SvH, and TS received in-kind support from the European Federation of Pharmaceutical Industries and Associations as part of the Innovative Medicines Initiative Joint Undertaking for the submitted work; CGA is a full time employee of Servier; HG, PB, and RaB are full time employees of Sanofi-Aventis; JS is a full time employee of Boehringer Ingelheim Pharma; MK is a full time employee of Astellas Pharma; RR and RRM are full time employees of Novartis; AJJ-C received grant support from Abbott Nutrition, Fresenius Kabi, and Nutricia outside of the submitted work, and personal fees from Abbott Nutrition, Fresenius Kabi, Nestlè, Nutricia, Pfizer, and Sanofi-Aventis outside of the submitted work; EM received personal fees from Abbott, Nestlè, Nutricia, and Thermofisher outside the submitted work; MC received personal fees from Nestlè outside the submitted work; RC received personal fees from Abbot and Nutricia outside the submitted work; SDA received grant support from Abbott and Vifor Pharma outside of the submitted work, and personal fees from Abbott, Bayer, Boehringer Ingelheim, Cardiac Dimension, Cordio, Impulse Dynamics, Novartis, Occlutech, Servier, and Vifor Pharma outside of the submitted work; SDS has a pending US patent; SvH received grant support from Amgen, Boehringer Ingelheim, and ZS Pharma outside of the submitted work and personal fees from AstraZeneca, Bayer, BRAHMS, Chugai, Grünenthal, Helsinn, Hexal, Merck Sharp and Dohme, Novartis, Pharmacosmos, Respicardia, Roche, Servier, and Sorin outside the submitted work; TF received personal fees from Bayer, BiosenseWebster, CSL Behring, Coherex Medical, Fresenius Kabi, Galapagos, Janssen, LivaNova, Minoryx, Novartis, Parexel, Penumbra, Roche, and Vifor Pharma outside the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influence
20. Observational Study - Rejuvenation Res -. 2022 Jun;25(3):129-140. doi: 10.1089/rej.2021.0063. Epub 2022 Jun 6.
COVID-19 as a Paradigmatic Model of the Heterogeneous Disease Presentation in Older People: Data from the GeroCovid Observational Study
Caterina Trevisan 1 2 , Francesca Remelli 1 , Stefano Fumagalli 3 4 , Enrico Mossello 3 4 , Chukwuma Okoye 5 , Giuseppe Bellelli 6 7 , Alessandra Coin 2 , Alba Malara 8 , Pietro Gareri 9 , Fabio Monzani 5 , Susanna Del Signore 10 , Gianluca Zia 10 , Raffaele Antonelli Incalzi 11 , Stefano Volpato 1 , GeroCovid Acute Ward Working Group
Affiliations
- Department of Medical Science, University of Ferrara, Ferrara, Italy.
- Geriatrics Division, Department of Medicine (DIMED), University of Padua, Padua, Italy.
- Department of Experimental and Clinical Medicine, University of Florence, Firenze, Italy.
- Division of Geriatric and Intensive Care Medicine, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy.
- Geriatrics Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
- School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.
- Acute Geriatric Unit, San Gerardo Hospital, Monza, Italy.
- ANASTE-Humanitas Foundation, Rome, Italy.
- CDCD Catanzaro Lido-ASP Catanzaro, Catanzaro, Italy.
- Bluecompanion Ltd, London, United Kingdom.
- Unit of Geriatrics, Department of Medicine, Campus Bio-Medico University and Teaching Hospital, Rome, Italy.
Collaborators
- GeroCovid Acute Ward Working Group:
Rachele Antognoli, Maria Paola Antonietti, Viviana Bagalà, Giulia Bandini, Enrico Benvenuti, Marina Bergamin, Marco Bertolotti, Carlo Adriano Biagini, Angelo Bianchetti, Alessandra Bianchi, Mariangela Bianchi, Silvia Bignamini, Damiano Blandini, Stefano Boffelli, Maura Bugada, Valeria Calsolaro, Donatella Calvani, Elisiana Carpagnano, Barbara Carrieri, Viviana Castaldo, Alessandro Cavarape, Ilaria Cazzulani, Carilia Celesti, Chiara Ceolin, Maria Giorgia Ceresini, Antonio Cherubini, Anita Chizzoli, Erika Ciarrocchi, Paola Cicciomessere, Annalisa Corsi, Carlo Custodero, Federica D'Agostino, Maria Maddalena D'Errico, Aurelio De Iorio, Alessandro De Marchi, Giovambattista Desideri, Evelyn Di Matteo, Emma Espinosa, Luigi Esposito, Chiara Fazio, Chiara Filippini, Lucia Fiore, Caterina Fontana, Lina Forte, Riccardo Franci Montorzi, Carlo Fumagalli, Antonella Giordano, Evelina Giuliani, Antonio Greco, Andrea Herbst, Giuseppe Ielo, Antonella La Marca, Umberto La Porta, Ilaria Lazzari, Diana Lelli, Yari Longobucco, Flaminia Lucchini, Daniela Lucente, Lorenzo Maestri, Marcello Maggio, Paola Mainquà, Alessandra Marengoni, Benedetta Martin, Valentina Massa, Liliana Mazza, Carmela Mazzoccoli, Federica Morellini, Chiara Mussi, Giuseppe Orio, Annalisa Paglia, Giulia Pelagalli, Laura Pelizzoni, Alessandro Picci, Anette Hylen Ranhoff, Onofrio Resta, Antonella Riccardi, Daniela Rinaldi, Renzo Rozzini, Carlo Sabbà, Leonardo Sacco, Mariateresa Santoliquido, Mariella Savino, Francesco Scarso, Giuseppe Sergi, Gaetano Serviddio, Chiara Sidoli, Vincenzo Solfrizzi, Benedetta Soli, Laura Tafaro, Andrea Tedde, Giuseppe Dario Testa, Maria Giulia Tinti, Francesco Tonarelli, Elisabetta Tonon, Aurora Vitali, Francesca Zoccarato, Sonia Zotti
Abstract
COVID-19 may have a heterogeneous onset, especially in older age. However, whether and how COVID-19 signs and symptoms may present and aggregate together according to sociodemographic and health factors is unclear, as well as their prognostic value. This study included 981 COVID-19 inpatients who participated in the GeroCovid Observational study. Signs/symptoms at disease onset, sociodemographic, health, cognitive status, and mobility were systematically recorded. Clusters of signs/symptoms were identified through agglomerative hierarchical clustering. The associations of single signs/symptoms and symptom clusters with longer hospitalization (≥16 days) and in-hospital mortality were explored through logistic and Cox regressions. The signs/symptoms most reported in our sample (age 78.3 ± 9.39 years; 49.4% women) were fever (62.5%), cough (45.5%), and dyspnea (62.7%). Atypical symptoms were reported by up to one-third of patients, and delirium by 9.1%. Atypical symptoms were more frequent with advancing age and with lower pre-COVID-19 cognitive and mobility levels. Older men more likely reported respiratory symptoms than women. Dyspnea (hazard ratio [HR] = 1.47, 95% confidence interval [CI]: 1.02-2.12), tachypnea (HR = 1.53, 95% CI: 1.14-2.07), low oxygen saturation (HR = 1.95, 95% CI: 1.32-2.88) and delirium (HR = 1.60, 95% CI: 1.13-2.28) were associated with higher in-hospital mortality. Four symptom clusters were identified. Compared with the mild respiratory symptoms cluster, the severe clinical impairment cluster was associated with higher mortality (HR = 2.57, 95% CI: 1.58-4.18). The severe clinical impairment and aspecific symptoms clusters were associated with longer hospitalization (odds ratio [OR] = 2.38, 95% CI: 1.56-3.63, and OR = 1.75, 95% CI: 1.08-2.83, respectively). Multiple health aspects influence COVID-19 clinical presentation. A symptom clusters approach may help predict adverse health outcomes in older patients. In addition to respiratory symptoms, delirium is independently associated with mortality risk. ClinicalTrials.gov (NCT04379440).
Keywords: COVID-19; aged; cluster analysis; mortality; signs and symptoms.
21. International Journal of Environmental Research and Public Health - 2022, 19, 11386. https://doi.org/10.3390/ijerph191811386
Indoor Mobility, Frailty, and Disability in Community-Dwelling Older Adults: A Mediation Model
Abstract
Affiliations
- Center for Diabetes Research, Medical Faculty, Université Libre de Bruxelles, Brussels, Belgium.
- Department of Medical Sciences, University of Ferrara, Ferrara, Italy.
- Department of Medicine, University of Padua, Padua, Italy.
- Aging Research Center, Karolinska Institutet, Stockholm, Sweden.
- Alzheimer's Disease Day Clinic, Azienda Sanitaria Locale, Frosinone, Italy.
- Associazione Nazionale Strutture Territoriali e per la Terza Età (ANASTE)-Humanitas Foundation, Rome, Italy.
- Istituto Superiore di Sanità, Roma, Italy.
- Institute of Neuroscience, National Research Council, Padua, Italy.
- Department of Medicine, Campus Bio-Medico University and Teaching Hospital, Rome, Italy.
- Università Cattolica Sacro Cuore, Rome, Italy.
Affiliations
- Biophytis, Sorbonne University, Paris, France.
- Bluecompanion Ltd, London, UK.
- FSI, Paris-Seine Biology Institute (BIOSIPE), CNRS, Sorbonne University, Paris, France.
Affiliations
- Department of Medicine (DIMED), Geriatrics Division, University of Padova, Padova, Italy.
- Department of General Psychology, University of Padova, Padova, Italy.
- Psychogeriatric Outpatient Clinic, Ortona, Italy.
- Geriatrics Unit, Azienda ULSS 16, Padova, Italy.
- Territorial Care Department, ASL NA2 Nord, Naples, Italy.
- B.V. Consolata" Rehabilitation Hospital-Fatebenefratelli, San Maurizio Canavese, Italy.
- Bluecompanion, Ldt, London, UK.
- Geriatrics Unit, Memory Clinic, Bozen Hospital, Bozen, Italy.
- Clinical Neuropsychology, S.Giovanni Battista Hospital, Foligno, Italy.
- Section of Geriatrics, Department of Internal Medicine and Medical Specialties (DIMI), University of Genoa, Genoa, Italy.
- CDCD DS 46 and 47, ASL Napoli 2 Nord, Naples, Italy.
- UOC Involutive Degenerative Diseases, Territorial Psychogeriatrics, ASP of Agrigento, Agrigento, Italy.
- CDCD, District 2, Trieste, Italy.
- Center for Cognitive Disorders and Dementia-Catanzaro Lido ASP, Catanzaro, Italy.
- Department of Medical Sciences, University of Ferrara, Ferrara, Italy.
- ANASTE Humanitas Foundation, Rome, Italy.
- Geriatric Intensive Care Unit, Department of Experimental and Clinical Medicine, University of Firenze, Firenze, Italy.
- Geriatrics Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
- School of Medicine and Surgery, Acute Geriatric Unit, University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy.
- Unit of Geriatrics, Department of Medicine, Campus Bio-Medico University and Teaching Hospital, Rome, Italy.
PMID: 37679953 DOI:10.1111/psyg.13021
Abstract
Background: The containment measures linked to the COVID-19 pandemic negatively affected the phyco-physical well-being of the population, especially older adults with neurocognitive disorders (NCDs). This study aims to evaluate whether the frailty of NCD patients was associated with different changes in multiple health domains, in particular in relation to loneliness and social isolation, pre- and post-lockdown.
Materials and methods: Patients were recruited from 10 Italian Centers for Cognitive Disorders and Dementia. Data were collected in the pre-pandemic period (T0), during the pandemic lockdown (T1), and 6-9 months post-lockdown (T2). The UCLA Loneliness Scale-3, Activities of Daily Living (ADL), Instrumental ADL (IADL), Mini-Mental State Examination, and Neuropsychiatric Inventory (NPI) were administered. Caregivers' burden was also tested. Patients were categorized as non-frail, pre-frail, and frail according to the Fatigue, Resistance, Ambulation, Illness, and Loss of Weight scale.
Results: The sample included 165 subjects (61.9% women, mean age 79.5 ± 4.9 years). In the whole sample, the ADL, IADL, and NPI scores significantly declined between T0 and T2. There were no significative variations in functional and cognitive domains between the frail groups. During lockdown we recorded higher Depression Anxiety Stress Scales and Perceived Stress Scale scores in frail people. In multivariable logistic regression, frailty was associated with an increase in social isolation, and a loss of IADL.
Conclusions: We observed a global deterioration in functional and neuro-psychiatric domains irrespective of the degree of frailty. Frailty was associated with the worsening of social isolation during lockdown. Frail patients and their caregivers seemed to experience more anxiety and stress disorders during SARS-CoV-2 pandemic.
Keywords: NPI; SARS-CoV-2; UCLA; frailty; older adults; social isolation.
© 2023 The Authors. Psychogeriatrics published by John Wiley & Sons Australia, Ltd on behalf of Japanese Psychogeriatric Society.
26. J Am Med Dir Assoc. 2023 Jun;24(6):926-927.e2. doi: 10.1016/j.jamda. 2023.01.026. Epub 2023 Mar 3
Promoting and Building Long-Term Care Health Research Networks: GeroCovid Observational and Gerocovid Vax Initiatives
Affiliations
Efficacy of COVID-19 control measures on post-vaccination outbreak in Italian Long Term Care Facilities: implications for policies
Affiliations
Abstract
Background: Numerous individual and organizational factors can influence the spread of SARS-CoV-2 infection in Long Term Care Facilities (LTCFs). A range of outbreak control measures are still implemented in most facilities involving administrations, staff, residents and their families. This study aims to evaluate which measure could influence the transmission of SARS-CoV-2 infection among residents during the period March 2021-June 2022.
Methods: We enrolled 3,272 residents aged ≥60 years. The outbreak control measures adopted to prevent or manage the infection included entry regulations, contact-regulating procedures, and virological surveillance of residents and staff. The association between LTCFs' and participants' characteristics with new cases of COVID-19 infections was analyzed using multilevel logistic regression models.
Results: In 33.8% of the facilities 261 cases of SARS-CoV-2 infection were reported. Among participant characteristics, gender and age were not associated with SARS-CoV-2 infection, while having received the vaccine booster dose was protective against infection [Odds Ratio (OR) = 0.34, 95% Confidence Interval (CI) 0.12-0.99, p = 0.048]. In addition, the implementation of protected areas for family visits was associated with a significant reduction of the probability of infections (OR = 0.18, 95% CI 0.03-0.98, p = 0.047). Overall, about 66% of the variability in the probability of SARS-CoV-2 infection during the observational period may be due to facility structure characteristics and 34% to the participant characteristics.
Conclusions: These data showed that vaccination booster doses and family visit restriction-control are still needed to make the LTCFs safer against SARS-CoV-2 infection.
Keywords: COVID-19 vaccination; Long Term Care Facilities (LTCFS); SARS CoV-2 infection; outbreak control measures; pandemic fatigue.