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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02735005
Other study ID # 2015-A00642-47
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date December 31, 2017

Study information

Verified date April 2018
Source Centre Hospitalier de la Région d'Annecy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 741
Est. completion date December 31, 2017
Est. primary completion date September 26, 2016
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
France FAM du Moulin Allinges
France APF - SAVS Annecy Annecy
France ESAT "Ateliers de Novel" Annecy
France FAM Le Goëland Annecy
France SAVS - Association Départementale des Infirmes Moteurs Cérébraux Annecy
France Savs Archim'Aide Annecy
France Savs Espoir 74-Oxygene Annecy
France ESAT Bellegarde Industries Bellegarde
France EHPAD Maison de Famille du Genevois Collonges sous Salève
France ESAT Ferme de Chosal Copponex
France ADMR Haute-Savoie - SSIAD/SAD Cran Gevrier
France ADTP Site de Cran-Gevrier (Entreprises Adaptées) Cran Gevrier
France Esat Messidor Cran Gevrier
France ESAT Antenne du pays de Gex Ferney Voltaire
France Foyer des Roseaux and FAM des Iris La Balme de Sillingy
France EHPAD La Bartavelle Meythet
France FAM Le Goëland Meythet
France FAM Résidence Leirens - Armée du Salut Monnetier Mornex Monnetier
France SAVS Association Vivre en Ville 01 Ornex
France ESAT L'Arcalod Rumilly
France Association ECLAT Pays de Gex Saint Genis
France FAM Pré la Tour Saint Jean
France ESAT Le Central Seynod
France ESAT Le Semnoz Seynod
France SAMSAH Le Bilboquet Seynod
France SAMSAH Le Fil d'Ariane Seynod
France ESAT Myriade Thônes
France Centre Arthur Lavy - FAM Le Cristal Thorens Glières
France Centre Arthur Lavy - MAS l'Opaline Thorens Glières
France Association "Nous aussi" - Foyer d'hébergement - SATTHAV Vetraz-Monthoux

Sponsors (3)

Lead Sponsor Collaborator
Centre Hospitalier de la Région d'Annecy Agence Régionale de Santé Rhône-Alpes, Conseil Départemental de haute-Savoie

Country where clinical trial is conducted

France, 

References & Publications (11)

Ahmed N, Mandel R, Fain MJ. Frailty: an emerging geriatric syndrome. Am J Med. 2007 Sep;120(9):748-53. — View Citation

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. — View Citation

Dubuc N, Hébert 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. Epub 2005 Aug 25. — View Citation

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. Review. — View Citation

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. — View Citation

Gervais P, Hébert 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. French. — View Citation

Pinsonnault E, Dubuc N, Desrosiers J, Delli-Colli N, Hébert 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. Epub 2007 Dec 3. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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