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Completed

NCT Number: NCT02335177

Technology and Human Help at Home After Hospitalisation

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.

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Key information

Conditions

Patient Fall Behavior Motor Activity

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP Charles Foix

Ivry-sur-Seine, 94205, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interventional arm

Behavioral

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.

Primary outcomes

  1. 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

  1. Timed up and Go test score

    Time frame: 3 months

  2. Barthel index

    Time frame: 3 months

  3. Duke questionnaire

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Ages et Vies Association

Other

Collaborators

  • Caisse Nationale de Solidarité pour l'Autonomie
  • Fondation Macif
  • National Insurance Fund Vieilleisse
  • Réunica

Registry information

Official study title

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

Acronym: T4H

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jan 9, 2015
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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