Determining the Needs of Aging People With Disabilities

NCT ID: NCT02735005

Last Updated: 2019-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

741 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-12-31

Brief Summary

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Heterogeneous modalities of aging lead to describe three categories of elderly patients: 1-healthy without frailty, 2- healthy with frailty, 3- patients with chronic disease(s) and frailty. Frail people have a high risk of losing functional independence and as a consequence they require more help for day to day life. It is known in elderly that physical activities, nutrition, social environment are important to maintain functional independence.

For patients with disabilities, less is known about the occurence of dependance with aging. That is of growing importance because life expectancy of disabled patients has increased a lot during last decades, and because caregivers, often parents, also become elderly and frail.

So the investigators will require tools to anticipate prevention and supportive needs for this specific population.

The goal of this study is to evaluate if the participants (disabled patients over 40 years old) of a well-defined region in the south-east of France (400000 inhabitants), and to assess their needs, using the Functional Autonomy Measurement System (SMAF) developed for assessment of the elderly, by Rejean Hebert \& Nicole Dubuc's team in Sherbrooke University (Quebec/Canada).

Detailed Description

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Conditions

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Disabled People Aging Mental Handicap

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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SMAF assessment

Face to face interview for the Functional Autonomy Measurement System (SMAF) tool questionnaire For disabled patients living at home, the Social SMAF questionnaire is used in addition.

Data related to care consumption of each enrolled patients are collected too.

Group Type EXPERIMENTAL

SMAF assessment

Intervention Type OTHER

After written information and non opposition expression, each enrolled patient will be assessed with the Functional Autonomy Measurement System (SMAF) tool during a 1 hour interview.

The French authority has considered this study as an interventional study with minimal risk because we use a tool (SMAF) that was not developped nor validated in this specific population (disabled people older than 40y). The SMAF assessment is not made in routine in this specific population (ID RCB : 2015-A00642-47)

Interventions

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SMAF assessment

After written information and non opposition expression, each enrolled patient will be assessed with the Functional Autonomy Measurement System (SMAF) tool during a 1 hour interview.

The French authority has considered this study as an interventional study with minimal risk because we use a tool (SMAF) that was not developped nor validated in this specific population (disabled people older than 40y). The SMAF assessment is not made in routine in this specific population (ID RCB : 2015-A00642-47)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adult 40 years or older
* must need help allocated by government social health services (Committee on Rights and Autonomy of Disabled People = french CDAPH)
* must live

1. either in dedicated units or specialized homes (french medicalized care homes, or dedicated community homes)
2. or at home but working in specialized dedicated centers (So called french Etablissement et Service d'Aide par le Travail) or requiring intervention of specialized services (Support Service for Social Life or Medical-Social Support Service for Disabled Adults)

Exclusion Criteria

* patient or patient's legal guardian opposed to participate
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agence Régionale de Santé Rhône-Alpes

OTHER

Sponsor Role collaborator

Conseil Départemental de haute-Savoie

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Annecy Genevois

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthieu DEBRAY, MD

Role: PRINCIPAL_INVESTIGATOR

CH Annecy Genevois, head of the gerontological sector

Max BUCHNER

Role: PRINCIPAL_INVESTIGATOR

Foyer le pré vert - Villeurbanne

Locations

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FAM du Moulin

Allinges, , France

Site Status

APF - SAVS Annecy

Annecy, , France

Site Status

ESAT "Ateliers de Novel"

Annecy, , France

Site Status

FAM Le Goëland

Annecy, , France

Site Status

SAVS - Association Départementale des Infirmes Moteurs Cérébraux

Annecy, , France

Site Status

Savs Archim'Aide

Annecy, , France

Site Status

Savs Espoir 74-Oxygene

Annecy, , France

Site Status

ESAT Bellegarde Industries

Bellegarde, , France

Site Status

EHPAD Maison de Famille du Genevois

Collonges-sous-Salève, , France

Site Status

ESAT Ferme de Chosal

Copponex, , France

Site Status

ADMR Haute-Savoie - SSIAD/SAD

Cran-Gevrier, , France

Site Status

ADTP Site de Cran-Gevrier (Entreprises Adaptées)

Cran-Gevrier, , France

Site Status

Esat Messidor

Cran-Gevrier, , France

Site Status

ESAT Antenne du pays de Gex

Ferney-Voltaire, , France

Site Status

Foyer des Roseaux and FAM des Iris

La Balme-de-Sillingy, , France

Site Status

EHPAD La Bartavelle

Meythet, , France

Site Status

FAM Le Goëland

Meythet, , France

Site Status

FAM Résidence Leirens - Armée du Salut Monnetier Mornex

Monnetier, , France

Site Status

SAVS Association Vivre en Ville 01

Ornex, , France

Site Status

ESAT L'Arcalod

Rumilly, , France

Site Status

Association ECLAT Pays de Gex

Saint-Genis, , France

Site Status

FAM Pré la Tour

Saint-Jean, , France

Site Status

ESAT Le Central

Seynod, , France

Site Status

ESAT Le Semnoz

Seynod, , France

Site Status

SAMSAH Le Fil d'Ariane

Seynod, , France

Site Status

SAMSAH Le Bilboquet

Seynod, , France

Site Status

Centre Arthur Lavy - FAM Le Cristal

Thorens-Glières, , France

Site Status

Centre Arthur Lavy - MAS l'Opaline

Thorens-Glières, , France

Site Status

ESAT Myriade

Thônes, , France

Site Status

Association "Nous aussi" - Foyer d'hébergement - SATTHAV

Vétraz-Monthoux, , France

Site Status

Countries

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France

References

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Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.

Reference Type BACKGROUND
PMID: 15031310 (View on PubMed)

Rubenstein LZ, Josephson KR, Wieland GD, English PA, Sayre JA, Kane RL. Effectiveness of a geriatric evaluation unit. A randomized clinical trial. N Engl J Med. 1984 Dec 27;311(26):1664-70. doi: 10.1056/NEJM198412273112604.

Reference Type BACKGROUND
PMID: 6390207 (View on PubMed)

Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet. 1993 Oct 23;342(8878):1032-6. doi: 10.1016/0140-6736(93)92884-v.

Reference Type BACKGROUND
PMID: 8105269 (View on PubMed)

Stuck AE, Egger M, Hammer A, Minder CE, Beck JC. Home visits to prevent nursing home admission and functional decline in elderly people: systematic review and meta-regression analysis. JAMA. 2002 Feb 27;287(8):1022-8. doi: 10.1001/jama.287.8.1022.

Reference Type BACKGROUND
PMID: 11866651 (View on PubMed)

Carlsen WR, Galluzzi KE, Forman LF, Cavalieri TA. Comprehensive geriatric assessment: applications for community-residing, elderly people with mental retardation/developmental disabilities. Ment Retard. 1994 Oct;32(5):334-40.

Reference Type BACKGROUND
PMID: 7984118 (View on PubMed)

Ahmed N, Mandel R, Fain MJ. Frailty: an emerging geriatric syndrome. Am J Med. 2007 Sep;120(9):748-53. doi: 10.1016/j.amjmed.2006.10.018.

Reference Type BACKGROUND
PMID: 17765039 (View on PubMed)

Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

Reference Type BACKGROUND
PMID: 11253156 (View on PubMed)

Pinsonnault E, Dubuc N, Desrosiers J, Delli-Colli N, Hebert R. Validation study of a social functioning scale: The social-SMAF (social-Functional Autonomy Measurement System). Arch Gerontol Geriatr. 2009 Jan-Feb;48(1):40-4. doi: 10.1016/j.archger.2007.10.001. Epub 2007 Dec 3.

Reference Type BACKGROUND
PMID: 18061289 (View on PubMed)

Dubuc N, Hebert R, Desrosiers J, Buteau M, Trottier L. Disability-based classification system for older people in integrated long-term care services: the Iso-SMAF profiles. Arch Gerontol Geriatr. 2006 Mar-Apr;42(2):191-206. doi: 10.1016/j.archger.2005.07.001. Epub 2005 Aug 25.

Reference Type BACKGROUND
PMID: 16125809 (View on PubMed)

Gervais P, Hebert R, Lamontagne J, Tousignant M. [Implementation of functional autonomy measurement system: barriers and facilitators in PISE-Dordogne project]. Geriatr Psychol Neuropsychiatr Vieil. 2011 Dec;9(4):417-28. doi: 10.1684/pnv.2011.0306. French.

Reference Type BACKGROUND
PMID: 22182818 (View on PubMed)

Vellas BJ, Wayne SJ, Romero L, Baumgartner RN, Rubenstein LZ, Garry PJ. One-leg balance is an important predictor of injurious falls in older persons. J Am Geriatr Soc. 1997 Jun;45(6):735-8. doi: 10.1111/j.1532-5415.1997.tb01479.x.

Reference Type BACKGROUND
PMID: 9180669 (View on PubMed)

Related Links

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http://www.credoc.fr/publications/abstract.php?ref=C256

Loones A, David-Alberola E, Jauneau P (dec 2008). La fragilité des personnes âgées : perceptions et mesures. Centre de Recherche pour l'Étude et l'Observation des Conditions de Vie. Cahier de recherche n°C256

http://www.hcsp.fr/explore.cgi/Adsp?clef=107

Pillard F, Rivière D (june 2009). Pratique d'une activité physique ou sportive chez les seniors. Dossier " Activités physiques ou sportives \& santé " adsp n° 67

http://www.ladocumentationfrancaise.fr/var/storage/rapports-publics/064000570/0000.pdf

Blanc P (2006). Une longévité accrue pour les personnes handicapées vieillissantes : un nouveau défi pour leur prise en charge. Rapport ministériel.

https://www.google.fr/search?q=Haveman+MJ+et+al+2009+Report+on+the+State+of+Science+on+Health+Risks+and+Ageing+in+People+with+Intellectual+Disabilities.+IASSID+Special+Interest+Research+Group+on+Ageing+and+Intellectual+Disabilities/Faculty+Rehabilitation+Sciences+University+of+Dortmund&ie=utf-8&oe=utf-8&gws_rd=cr&ei=cenyVrC1O4j1aIWQlcAJ

Haveman M et al 2009 Report on the State of Science on Health Risks and Ageing in People with Intellectual Disabilities.Special Interest Research Group on Ageing and Intellectual Disabilities/Faculty Rehabilitation Sciences University of Dortmund

http://www.sante.gouv.fr/IMG/pdf/rapport-pjacob-0306-macarlotti.pdf

Rapport Jacob (2013). Un droit citoyen pour la personne handicapée. Un parcours de soins et de santé sans rupture d'accompagnement.

http://www.iumsp.ch/Publications/pdf/rds191_fr.pdf

Seematter-Bagnoud L et al (2012). Le Resident Assessment Instrument et autres instruments d'évaluation des personnes âgées. Lausanne : Institut universitaire de médecine sociale et préventive. (Raisons de santé, 191)

Other Identifiers

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2015-A00642-47

Identifier Type: -

Identifier Source: org_study_id

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