NCT02335177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

January 7, 2015

Last Update Submit

May 24, 2017

Conditions

Patient Fall

Keywords

FallsElderlyPhysical activitiesTechnologies for autonomyImpact of interventionautonomyphysical activity program

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Timed up and Go test score

    3 months

  • Barthel index

    3 months

  • Duke questionnaire

    3 months

Study Arms (2)

Interventionnal arm

ACTIVE COMPARATOR

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

Behavioral: Interventional arm

Control arm

NO INTERVENTION

Control arm : patients with usual care home

Interventions

Interventional armBEHAVIORAL

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.

Interventionnal arm

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP Charles Foix

Ivry-sur-Seine, 94205, France

Location

Related Publications (1)

  • Meziere A, Oubaya N, Michel-Pellegrino V, Boudin B, Neau M, Robert H, Cara I, Salgado Sanchez L, Baloul S, Piette F, Pautas E, Picou Y, Curtis V, Schonheit C, Canoui-Poitrine F, Moreau C. Exercise Interventions With Trained Home Helpers for Preventing Loss of Autonomy and Falls in Community-Dwelling Older Adults Receiving Home Heath Physical Therapy T4H: A Randomized Controlled Pilot Study. J Geriatr Phys Ther. 2021 Jul-Sep 01;44(3):E138-E149. doi: 10.1519/JPT.0000000000000287.

    PMID: 33534333DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Meziere Anthony, Dr

    Hôpital Charles Foix, AP-HP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 9, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

FR(1)