T4H: Technology and Human Help at Home After Hospitalisation

Sponsor

Ages et Vies Association (Other)

Overall Status

Completed

CT.gov ID

NCT02335177

Collaborator

Caisse Nationale de Solidarité pour l'Autonomie (Other), National Insurance Fund Vieilleisse (Other), Réunica (Other), Fondation Macif (Other)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Patient Fall	Behavioral: Interventional arm	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Interventionnal arm Interventional arm : patients at home with technologies for autonomy and tailored physical activity program.	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.
No Intervention: Control arm Control arm : patients with usual care home

Arm

Intervention/Treatment

Active Comparator: Interventionnal arm

Interventional arm : patients at home with technologies for autonomy and tailored physical activity program.

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.

No Intervention: Control arm

Control arm : patients with usual care home

Outcome Measures

Primary Outcome Measures

Number of falls [3 months]
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

Secondary Outcome Measures

Timed up and Go test score [3 months]
Barthel index [3 months]
Duke questionnaire [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.