Determining the Needs of Aging People With Disabilities

NCT02735005 | Completed DMC

• 1 other identifier: 2015-A00642-47
• Study Type: interventional
• Target: 741
• Locations: 1 country
• Sites: 30

Brief Summary

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).

Conditions

Disabled People; Aging; Mental Handicap

Outcome Measures

Primary Outcomes (1)

• Needs in supports for aging disabled patients

  classification into one of the fourteen homogenous profiles of the Fonctional Autonomy Measurement System (SMAF) tool. The SMAF tool is a software based on responses of 29 predefined items on incapacities (with 4 modalities of response for each) and care and ressources used by interviewed people. The social SMAF tool adds 6 supplementary items (also with 4 modalities of response for each). Predefined algorithms defined for not disabled elderly people leads to classification into 14 homogeneous profiles. Progression's modalities of elderly from one profile to another is well known. The goal of this study is to determine if the same tool could be used for a younger disabled population, and if not, we want to build other algorithms dedicated to this aging disabled population. That's why this study is performed in collaboration with the Sherbrooke's team who designed the SMAF tool.

  through study completion, an average of 1 year

Study Arms (1)

SMAF assessment

EXPERIMENTAL

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.

Other: SMAF assessment

Interventions

SMAF assessment 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)

SMAF assessment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• either in dedicated units or specialized homes (french medicalized care homes, or dedicated community homes)
• 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)

You may not qualify if:

• patient or patient's legal guardian opposed to participate

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead
• Agence Régionale de Santé Rhône-Alpes: collaborator
• Conseil Départemental de haute-Savoie: collaborator

Study Sites (30)

FAM du Moulin

Allinges, 74500, France

Location

APF - SAVS Annecy

Annecy, 74000, France

Location

ESAT "Ateliers de Novel"

Annecy, 74000, France

Location

FAM Le Goëland

Annecy, 74000, France

Location

SAVS - Association Départementale des Infirmes Moteurs Cérébraux

Annecy, 74000, France

Location

Savs Archim'Aide

Annecy, 74000, France

Location

Savs Espoir 74-Oxygene

Annecy, 74000, France

Location

ESAT Bellegarde Industries

Bellegarde, 01200, France

Location

EHPAD Maison de Famille du Genevois

Collonges-sous-Salève, 74160, France

Location

ESAT Ferme de Chosal

Copponex, 74350, France

Location

ADMR Haute-Savoie - SSIAD/SAD

Cran-Gevrier, 74900, France

Location

ADTP Site de Cran-Gevrier (Entreprises Adaptées)

Cran-Gevrier, 74960, France

Location

Esat Messidor

Cran-Gevrier, 74960, France

Location

ESAT Antenne du pays de Gex

Ferney-Voltaire, 01210, France

Location

Foyer des Roseaux and FAM des Iris

La Balme-de-Sillingy, 74330, France

Location

EHPAD La Bartavelle

Meythet, 74960, France

Location

FAM Le Goëland

Meythet, 74960, France

Location

FAM Résidence Leirens - Armée du Salut Monnetier Mornex

Monnetier, 74560, France

Location

SAVS Association Vivre en Ville 01

Ornex, 01210, France

Location

ESAT L'Arcalod

Rumilly, 74150, France

Location

Association ECLAT Pays de Gex

Saint-Genis, 01630, France

Location

FAM Pré la Tour

Saint-Jean, 01630, France

Location

ESAT Le Central

Seynod, 74600, France

Location

ESAT Le Semnoz

Seynod, 74600, France

Location

SAMSAH Le Fil d'Ariane

Seynod, 74600, France

Location

SAMSAH Le Bilboquet

Seynod, 74960, France

Location

Centre Arthur Lavy - FAM Le Cristal

Thorens-Glières, 74570, France

Location

Centre Arthur Lavy - MAS l'Opaline

Thorens-Glières, 74570, France

Location

ESAT Myriade

Thônes, 74230, France

Location

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

Vétraz-Monthoux, 74106, France

Location

Related Publications (11)

• 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.

  PMID: 17765039 BACKGROUND

• 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.

  PMID: 11253156 BACKGROUND

• 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.

  PMID: 15031310 BACKGROUND

• 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.

  PMID: 6390207 BACKGROUND

• 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.

  PMID: 8105269 BACKGROUND

• 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.

  PMID: 11866651 BACKGROUND

• 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.

  PMID: 7984118 BACKGROUND

• 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.

  PMID: 18061289 BACKGROUND

• 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.

  PMID: 16125809 BACKGROUND

• 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.

  PMID: 22182818 BACKGROUND

• 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.

  PMID: 9180669 BACKGROUND

Related Links

• 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
• 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
• Blanc P (2006). Une longévité accrue pour les personnes handicapées vieillissantes : un nouveau défi pour leur prise en charge. Rapport ministériel.
• 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
• Rapport Jacob (2013). Un droit citoyen pour la personne handicapée. Un parcours de soins et de santé sans rupture d'accompagnement.
• 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)
• Gohet P (Nov 2013) L'avancée en âge des personnes handicapées, contribution à la réflexion.

Study Officials

• Matthieu DEBRAY, MD

  CH Annecy Genevois, head of the gerontological sector

  PRINCIPAL INVESTIGATOR

• Max BUCHNER

  Foyer le pré vert - Villeurbanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 12, 2016
• Study Start: August 1, 2015
• Primary Completion: September 26, 2016
• Study Completion: December 31, 2017
• Last Updated: June 18, 2019

Record last verified: 2018-04

Locations

FR (30)