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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02335177
Other study ID # 2014-A00579-38
Secondary ID
Status Completed
Phase N/A
First received January 7, 2015
Last updated May 24, 2017
Start date February 2015
Est. completion date January 2016

Study information

Verified date May 2017
Source Ages et Vies Association
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Elderly people are still at risk for falling at home. The objective of the study is to evaluate at home the impact of an intervention for 3 months combining technologies for autonomy and tailored physical activity program. The study is performed among patients aged 75 years and over leaving Charles Foix Geriatrics hospital or already supported by carer of professional home-care service Ages & Vie and with a loss of autonomy requiring physiotherapy and home support workers. It is a prospective, randomized, single-center, in cluster study which compares a Patient group (interventional group) with the intervention program (technologies + physical activities) with a control group benefiting from usual care home. Our hypothesis is that in the interventional group fewer falls were observed and improved different scores (Timed Up and Go Test,Barthel index, Quality of Life questionnaire of Duke) were reported compared to the control group.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date January 2016
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria:

- patients hospitalized in Charles Foix Hospital (France) and returning home or already supported by carer of professional home-care service Ages & Vie

- > 75 years old with loss of autonomy

- at risk for falling

- able to read and understand the information letter and consent letter

- patient requiring physiotherapy and caregiver at home.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Interventional arm
At home patients have both technologies for autonomy (walkers, treadmill) and tailored physical activity program performed with the help of the home carer. Intervention takes 3 months. Assessment at hospital discharge et at 3 months.

Locations

Country Name City State
France AP-HP Charles Foix Ivry sur Seine

Sponsors (5)

Lead Sponsor Collaborator
Ages et Vies Association Caisse National d Assurance Vieilleisse, Caisse Nationale de Solidarité pour l'Autonomie, Fondation Macif, Réunica

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of falls absence of fall requiring medical or paramedical care and improvement of the Timed Up and Go Test (TUG) or improvement of the autonomy level assessed by Barthel Index with at least stability of the test that is not improved 3 months
Secondary Timed up and Go test score 3 months
Secondary Barthel index 3 months
Secondary Duke questionnaire 3 months
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