Technology and Human Help at Home After Hospitalisation

Study Overview
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Brief Summary
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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.

Official Title
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Technology and Human Help at Home After Hospitalisation (T4H): a Randomized Clustered Controlled Trial

Conditions
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Patient Fall

Intervention / Treatment
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* Behavioral: Interventional arm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interventionnal arm<br>Interventional arm : patients at home with technologies for autonomy and tailored physical activity program. | Behavioral: Interventional arm<br>* 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.<br>|
| No Intervention: Control arm<br>Control arm : patients with usual care home | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed up and Go test score |  | 3 months | 
| Barthel index |  | 3 months | 
| Duke questionnaire |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Falls, Elderly, Physical activities, Technologies for autonomy, Impact of intervention, autonomy, physical activity program