Disabled PeoplePHVNCT02735005

Determining the Needs of Aging People With Disabilities

A study testing SMAF assessment in people with Disabled People and Aging, run by Centre Hospitalier Annecy Genevois at 30 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Disabled People, Aging, Mental Handicap
What is being tested?: SMAF assessment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 741 participants
Where: 30 sitesFrance
Study dates: Aug 2015to 31 Dec 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

patient or patient's legal guardian opposed to participate

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

France30 sites

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

Other trials in France

About this study

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

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
Being tested: SMAF assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SMAF assessmentOther
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)

Study groups in NCT02735005
Study group	Role	What they receive
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. Receives: Other: SMAF assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201531 Dec 2017

First posted12 Apr 2016 (estimated)
Study startAug 2015
Primary completion26 Sep 2016
Study completion31 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Disabled PeopleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 741 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02735005
Sponsor's protocol ID: 2015-A00642-47
Acronym: PHV
Status last verified: Apr 2018
First submitted: 24 Mar 2016
Last updated: 18 Jun 2019
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 17765039
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.
PubMed 11253156
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.
PubMed 15031310
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.
PubMed 6390207
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.
PubMed 8105269
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.
PubMed 11866651
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.
PubMed 7984118
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.
PubMed 18061289
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.
PubMed 16125809
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.
PubMed 22182818
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.
PubMed 9180669

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Adapting, Implementing and Evaluating the Effectiveness of HARP for People With Disabilities
Disabilities Physical, Falls
Active, not recruitingPhase 3
Evaluation of a Disability-Focused Sexual and Reproductive Health Curriculum for Health Students in Tanzania
Sexual and Reproductive Health, Disability
Recruiting
PRACOH Prevention Breakdown Support Advice Guidance Disability
Person With a Disability, Caregiver
Not yet recruiting
Reduction of Anxiety Through Dual Treatment: Digital CBT & NBHWC Coaching
Hearing Disability, Anxiety
Not yet recruiting
Reduction of Depression Through Dual Treatment: Digital CBT & NBHWC Coaching
Hearing Disability, Depression

All Disabled People trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02735005
Acronym / sponsor ID: PHV / 2015-A00642-47
Conditions: Disabled People, Aging, Mental Handicap
Study type: Interventional
Recruitment status: Completed
Enrolment: 741 participants (actual)
Lead sponsor: Centre Hospitalier Annecy GenevoisUniversity, hospital or other
Collaborators: Agence Régionale de Santé Rhône-Alpes, Conseil Départemental de haute-Savoie
Study start: Aug 2015
Primary completion: 26 Sep 2016 (actual)
Study completion: 31 Dec 2017 (actual)
First posted: 12 Apr 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SMAF assessment	Experimental	Other: SMAF assessmentFace 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.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

patient or patient's legal guardian opposed to participate

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SMAF assessmentAfter 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)	Other	SMAF assessment

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
Background: PubMed 17765039Ahmed 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.
Background: PubMed 11253156Fried 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.
Background: PubMed 15031310Fried 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.
Background: PubMed 6390207Rubenstein 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.
Background: PubMed 8105269Stuck 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.
Background: PubMed 11866651Stuck 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.
Background: PubMed 7984118Carlsen 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.
Background: PubMed 18061289Pinsonnault 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.
Background: PubMed 16125809Dubuc 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.
Background: PubMed 22182818Gervais 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.
Background: PubMed 9180669Vellas 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.
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°C256Link provided by the sponsor.
Pillard F, Rivière D (june 2009). Pratique d'une activité physique ou sportive chez les seniors. Dossier " Activités physiques ou sportives \& santé " adsp n° 67Link provided by the sponsor.
Blanc P (2006). Une longévité accrue pour les personnes handicapées vieillissantes : un nouveau défi pour leur prise en charge. Rapport ministériel.Link provided by the sponsor.
Michaudon H (2002). Les personnes handicapées vieillissantes : une approche à partir de l'enquête Handicaps-invalidités-dépendance. In : Drees Études et Résultats; 204.Link provided by the sponsor.
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 DortmundLink provided by the sponsor.
Rapport Jacob (2013). Un droit citoyen pour la personne handicapée. Un parcours de soins et de santé sans rupture d'accompagnement.Link provided by the sponsor.

Related trials for Disabled People

Recruiting
Adapting, Implementing and Evaluating the Effectiveness of HARP for People With Disabilities
Disabilities Physical, Falls
Active, not recruitingPhase 3
Evaluation of a Disability-Focused Sexual and Reproductive Health Curriculum for Health Students in Tanzania
Sexual and Reproductive Health, Disability
Recruiting
PRACOH Prevention Breakdown Support Advice Guidance Disability
Person With a Disability, Caregiver
Not yet recruiting
Reduction of Anxiety Through Dual Treatment: Digital CBT & NBHWC Coaching
Hearing Disability, Anxiety
Not yet recruiting
Reduction of Depression Through Dual Treatment: Digital CBT & NBHWC Coaching
Hearing Disability, Depression

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthieu DEBRAY, MD principal investigator

CH Annecy Genevois, head of the gerontological sector

Max BUCHNER principal investigator

Foyer le pré vert - Villeurbanne

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SMAF assessment in people with Disabled People and Aging, run by Centre Hospitalier Annecy Genevois at 30 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Needs in supports for aging disabled patients (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02735005, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.