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Clinical Trials/NCT02335177
NCT02335177CompletedNot Applicable

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

Ages et Vies Association2 sites in 1 country36 target enrollmentStarted: February 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
36
Locations
2
Primary Endpoint
Number of falls

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
70 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Duke questionnaire(3 months)
  • Timed up and Go test score(3 months)
  • Barthel index(3 months)

Investigators

Sponsor
Ages et Vies Association
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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