NCT03738709

Brief Summary

The primary outcome is to assess the impact of the group program on falls prevention and patient education on home modifications and the implementation of technical assistance. This study aims to demonstrate that a group program on falls prevention and patient education will improve the acceptance and the implementation of recommendations on technical assistance and home modifications following discharge after an hospitalization for fall. The secondary outcome will measure the impact of the group program on the incidence of falls, the number of readmissions, fear of another fall and improvement in walking and balance skills.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

December 4, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

3.1 years

First QC Date

October 26, 2018

Last Update Submit

December 11, 2018

Conditions

Keywords

PreventionGroupTechnical assistanceFallOccupational therapyHospitalization discharge

Outcome Measures

Primary Outcomes (1)

  • Number of technical assistance and home modifications implemented following discharge in both groups, in regard to the number of recommendations given during the hospitalization.

    1 month after hospitalization discharge (patient call #1)

Secondary Outcomes (8)

  • Number of technical assistance and home modifications implemented following discharge in both groups, in regard to the number of recommendations given during the hospitalization.

    6 months after hospitalization discharge (patient call #2)

  • Number of falls followed or not by an hospitalization since the discharge.

    6 months after the hospitalization discharge (patient call #2)

  • Fear of falling rate

    At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)

  • Evaluation of balance skills in daily living activities

    At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)

  • Evaluation of the walking by the "Stop Walking when Talking" test

    At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)

  • +3 more secondary outcomes

Study Arms (2)

Occupational therapy group sessions

EXPERIMENTAL

In the collective experimental group, the care includes 6 group sessions of one hour each, programmed over 2 weeks and progressive courses.

Behavioral: Falls prevention and education giving a demonstration of the usage of technical assistance.

Individual Occupational therapy sessions

ACTIVE COMPARATOR

In the individual control group, care consists of 6 individual sessions of 45 minutes each, not programmed over 2 weeks and progressive courses.

Behavioral: Falls prevention and education giving a demonstration of the usage of technical assistance.

Interventions

* Ecological trail to work on balance and walking. * Technical assistance presentation and try-outs within the therapeutic apartment. * Discussion on the perceived feelings over the exercises and the technical assistance submitted. * Falls Education and prevention, screening of the dangerous activities and education on the safe behaviours.

Also known as: Occupational Therapy
Individual Occupational therapy sessionsOccupational therapy group sessions

Eligibility Criteria

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

You may qualify if:

  • Male/Female over 70 years old living at home and not in a nursing home, hospitalized after a fall or for a falls evaluation.
  • Mini mental state examination score over or even 20/30.
  • The person is planning to return home after discharge.

You may not qualify if:

  • Decompensated medical pathologies.
  • Severe chronical diseases with symptoms that are not stabilized by medical or non-medical treatments.
  • Dizziness/vertigo linked to a vestibular or cerebellar disorder.
  • Sensory disability preventing communication and participation in the group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Soins de Suite et de Réadaptation Gériatrique - Ergothérapie -Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Interventions

Occupational Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Stéphanie BETTINELLI

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

October 26, 2018

First Posted

November 13, 2018

Study Start

December 4, 2018

Primary Completion

January 1, 2022

Study Completion

June 1, 2022

Last Updated

December 12, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations