- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02335177
Technology and Human Help at Home After Hospitalisation (T4H)
May 24, 2017 updated by: Ages et Vies Association
Technology and Human Help at Home After Hospitalisation (T4H): a Randomized Clustered Controlled Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ivry sur Seine, France, 94205
- AP-HP Charles Foix
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Interventionnal arm
Interventional arm : patients at home with technologies for autonomy and tailored physical activity program.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of falls
Time Frame: 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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Timed up and Go test score
Time Frame: 3 months
|
3 months
|
Barthel index
Time Frame: 3 months
|
3 months
|
Duke questionnaire
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Meziere Anthony, Dr, Hôpital Charles Foix, AP-HP
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
January 7, 2015
First Submitted That Met QC Criteria
January 8, 2015
First Posted (Estimate)
January 9, 2015
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 24, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2014-A00579-38
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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