Technology and Human Help at Home After Hospitalisation

Patient Fall Clinical Trial

— T4H  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335177
• Other study ID #: 2014-A00579-38
• Status: Completed
• Phase: N/A
• First received: January 7, 2015
• Last updated: May 24, 2017
• Start date: February 2015
• Est. completion date: January 2016

Study information

• Verified date: May 2017
• Source: Ages et Vies Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patient Fall

Intervention

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.

Locations

Country	Name	City	State
France	AP-HP Charles Foix	Ivry sur Seine

Sponsors (5)

Lead Sponsor	Collaborator
Ages et Vies Association	Caisse National d Assurance Vieilleisse, Caisse Nationale de Solidarité pour l'Autonomie, Fondation Macif, Réunica

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Timed up and Go test score		3 months
Secondary	Barthel index		3 months
Secondary	Duke questionnaire		3 months