Determining the Needs of Aging People With Disabilities (PHV)

June 14, 2019 updated by: Centre Hospitalier Annecy Genevois

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

741

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Allinges, France, 74500
        • FAM du Moulin
      • Annecy, France, 74000
        • 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
      • Bellegarde, France, 01200
        • ESAT Bellegarde Industries
      • Collonges sous Salève, France, 74160
        • EHPAD Maison de Famille du Genevois
      • Copponex, France, 74350
        • ESAT Ferme de Chosal
      • Cran Gevrier, France, 74900
        • ADMR Haute-Savoie - SSIAD/SAD
      • Cran Gevrier, France, 74960
        • ADTP Site de Cran-Gevrier (Entreprises Adaptées)
      • Cran Gevrier, France, 74960
        • Esat Messidor
      • Ferney Voltaire, France, 01210
        • ESAT Antenne du pays de Gex
      • La Balme de Sillingy, France, 74330
        • Foyer des Roseaux and FAM des Iris
      • Meythet, France, 74960
        • EHPAD La Bartavelle
      • Meythet, France, 74960
        • FAM Le Goëland
      • Monnetier, France, 74560
        • FAM Résidence Leirens - Armée du Salut Monnetier Mornex
      • Ornex, France, 01210
        • SAVS Association Vivre en Ville 01
      • Rumilly, France, 74150
        • ESAT L'Arcalod
      • Saint Genis, France, 01630
        • Association ECLAT Pays de Gex
      • Saint Jean, France, 01630
        • FAM Pré la Tour
      • Seynod, France, 74600
        • ESAT Le Central
      • Seynod, France, 74600
        • ESAT Le Semnoz
      • Seynod, France, 74600
        • SAMSAH Le Fil d'Ariane
      • Seynod, France, 74960
        • SAMSAH Le Bilboquet
      • Thorens Glières, France, 74570
        • Centre Arthur Lavy - FAM Le Cristal
      • Thorens Glières, France, 74570
        • Centre Arthur Lavy - MAS l'Opaline
      • Thônes, France, 74230
        • ESAT Myriade
      • Vetraz-Monthoux, France, 74106
        • Association "Nous aussi" - Foyer d'hébergement - SATTHAV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Annecy Genevois

Collaborators

Agence Régionale de Santé Rhône-Alpes
Conseil Départemental de haute-Savoie

Investigators

  • Principal Investigator: Matthieu DEBRAY, MD, CH Annecy Genevois, head of the gerontological sector
  • Principal Investigator: Max BUCHNER, Foyer le pré vert - Villeurbanne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

September 26, 2016

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

March 24, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 14, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-A00642-47

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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