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Determining the Needs of Aging People With Disabilities (PHV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02735005
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : April 10, 2018
Agence Régionale de Santé Rhône-Alpes
Conseil Départemental de haute-Savoie
Information provided by (Responsible Party):
Centre Hospitalier de la Région d'Annecy

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).

Condition or disease Intervention/treatment Phase
Disabled People Aging Mental Handicap Other: SMAF assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 741 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Epidemiology of Aging of People With Disabilities - Gerontological Sector "Rumilly-Annecy-Saint-Julien-Pays de Gex-Bellegarde" : Description of the Population in an Attempt to Identify Ways to Implement to Meet the Needs in Aging
Study Start Date : August 2015
Actual Primary Completion Date : September 26, 2016
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Disabilities

Arm Intervention/treatment
Experimental: 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.

Other: 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)

Primary Outcome Measures :
  1. Needs in supports for aging disabled patients [ Time Frame: through study completion, an average of 1 year ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02735005

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FAM du Moulin
Allinges, France, 74500
APF - SAVS Annecy
Annecy, France, 74000
ESAT "Ateliers de Novel"
Annecy, France, 74000
FAM Le Goëland
Annecy, France, 74000
SAVS - Association Départementale des Infirmes Moteurs Cérébraux
Annecy, France, 74000
Savs Archim'Aide
Annecy, France, 74000
Savs Espoir 74-Oxygene
Annecy, France, 74000
ESAT Bellegarde Industries
Bellegarde, France, 01200
EHPAD Maison de Famille du Genevois
Collonges sous Salève, France, 74160
ESAT Ferme de Chosal
Copponex, France, 74350
ADMR Haute-Savoie - SSIAD/SAD
Cran Gevrier, France, 74900
ADTP Site de Cran-Gevrier (Entreprises Adaptées)
Cran Gevrier, France, 74960
Esat Messidor
Cran Gevrier, France, 74960
ESAT Antenne du pays de Gex
Ferney Voltaire, France, 01210
Foyer des Roseaux and FAM des Iris
La Balme de Sillingy, France, 74330
EHPAD La Bartavelle
Meythet, France, 74960
FAM Le Goëland
Meythet, France, 74960
FAM Résidence Leirens - Armée du Salut Monnetier Mornex
Monnetier, France, 74560
SAVS Association Vivre en Ville 01
Ornex, France, 01210
ESAT L'Arcalod
Rumilly, France, 74150
Association ECLAT Pays de Gex
Saint Genis, France, 01630
FAM Pré la Tour
Saint Jean, France, 01630
ESAT Le Central
Seynod, France, 74600
ESAT Le Semnoz
Seynod, France, 74600
SAMSAH Le Fil d'Ariane
Seynod, France, 74600
SAMSAH Le Bilboquet
Seynod, France, 74960
Centre Arthur Lavy - FAM Le Cristal
Thorens Glières, France, 74570
Centre Arthur Lavy - MAS l'Opaline
Thorens Glières, France, 74570
ESAT Myriade
Thônes, France, 74230
Association "Nous aussi" - Foyer d'hébergement - SATTHAV
Vetraz-Monthoux, France, 74106
Sponsors and Collaborators
Centre Hospitalier de la Région d'Annecy
Agence Régionale de Santé Rhône-Alpes
Conseil Départemental de haute-Savoie
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Principal Investigator: Matthieu DEBRAY, MD CH Annecy Genevois, head of the gerontological sector
Principal Investigator: Max BUCHNER Foyer le pré vert - Villeurbanne

Additional Information:
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  This link exits the site 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  This link exits the site Blanc P (2006). Une longévité accrue pour les personnes handicapées vieillissantes : un nouveau défi pour leur prise en charge. Rapport ministériel.  This link exits the site Michaudon H (2002). Les personnes handicapées vieillissantes : une approche à partir de l'enquête Handicaps-invalidités-dépendance. In : Drees Études et Résultats; 204.  This link exits the site 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  This link exits the site Rapport Jacob (2013). Un droit citoyen pour la personne handicapée. Un parcours de soins et de santé sans rupture d'accompagnement.  This link exits the site Delporte M, Guinchard M (nov 2012). Creai Nord/Pas-de-Calais. Rapport : Accompagner le vieillissement des personnes en situation de Handicap  This link exits the site 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)  This link exits the site Dubuc N et al 2007 Clientèles en déficience physique et intellectuelle desservies en Centre local de services communautaires : Représentation des besoins liés à l'autonomie fonctionnelle selon la classification des profils Iso-SMAF. In PRISMA volume II  This link exits the site Michel J (may 2014). Importance du concept de fragilité pour détecter et prévenir les dépendances "évitables" au cours du vieillissement. Rapport de l'Académie Nationale de Médecine.  This link exits the site Gohet P (Nov 2013) L'avancée en âge des personnes handicapées, contribution à la réflexion.  This link exits the site

Publications of Results:

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Responsible Party: Centre Hospitalier de la Région d'Annecy Identifier: NCT02735005     History of Changes
Other Study ID Numbers: 2015-A00642-47
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018