Occupational Therapy Group Program on Falls Prevention and Patient Education for the Older Adults Hospitalized (ENCRAGE)

Occupational Therapy Group Program on Falls Prevention and Patient Education for the Older Adults Hospitalized in Service de Soins de Suite et de Réadaptation Gériatrique (SSRG) at Hôpitaux Universitaires de Strasbourg (HUS)

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.

Study Overview

• Status: Unknown
• Conditions: Fall
• Intervention / Treatment: Behavioral: Falls prevention and education giving a demonstration of the usage of technical assistance.

• Study Type: Interventional
• Enrollment (Anticipated): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service de Soins de Suite et de Réadaptation Gériatrique - Ergothérapie -Hôpitaux Universitaires de Strasbourg
    • Contact: Stéphanie BETTINELLI; Phone Number: +33 (0)3 88 11 55 51; Email: stephanie.bettinelli@chru-strasbourg.fr
    • Principal Investigator: Stéphanie BETTINELLI
    • Sub-Investigator: Lauriane FISCHER
    • Sub-Investigator: Flavie GAUTIER
    • Sub-Investigator: Benoit BECKER
    • Sub-Investigator: Amélie WILD
    • Sub-Investigator: Inmaculada HITA TEROL
    • Sub-Investigator: Thomas VOGEL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Occupational therapy group sessions; 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.; 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.; Other Names: Occupational Therapy
Active Comparator: Individual Occupational therapy sessions; 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.; 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.; Other Names: Occupational Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The number of potential falls in the 6 months after discharge will be measured by a telephone call to the patient (if impossible, the call will be placed to his caregiver or nurse).	6 months after the hospitalization discharge (patient call #2)
Fear of falling rate	Fear of falling will be measured by the Falls Efficacy Scale I [FES-I] (score from 16 to 64; higher values represent a stronger fear of falling)	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	Balance skills will be measured by the "Equilibre et Vie Quotidienne" scale: scored from 6 (no danger) to 24 (high risk of fall with impossibility to realize the 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	Positive test (pathological) if the subject stops walking when the therapist introduces a conversation	At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Evaluation of the motor skills by the Minimum Motor Test	20 items distributed in 4 themes: mobility in decubitus, sitting position, standing position, walking. Each item rated from 0 (motor skill abnormal) to 1 (motor skill preserved) Total score from 0 to 20; higher values represent preserved motor skills	At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Evaluation of the walking speed by the Timed Up and Go test.	The time of the course (in seconds) is retained as the final score. The test is positive if the score is 14 seconds or more, representing a risk of falling.	At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Evaluation of the number of footsteps in a 10 meters walk, by the Walk test on 10 meters.	The score corresponds to the number of footsteps performed by the subject. Pathological score from 13 footsteps.	At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Stéphanie BETTINELLI, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Prevention; Occupational therapy; Fall; Group; Technical assistance; Hospitalization discharge
• Other Study ID Numbers: 6790

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No