Effects of the COTID (Community Occupational Therapist in Dementia) Program and Usual Occupational Therapy Care on Recurrence of Falls at 12 Months in Elderly People With Neurocognitive Disorders Who Had Been Hospitalized for Falls, After Their Return Home (ErgoFalls)

January 12, 2026 updated by: University Hospital, Limoges

Effets du Programme COTID (Community Occupational Therapist in Dementia) et d'Une Prise en Soins ergothérapique Habituelle Sur la récidive de Chutes à 12 Mois de Personnes âgées Atteintes de Troubles Neurocognitifs et Ayant été hospitalisées Pour Chute, après Leur Retour à Domicile

This project will enable optimization of specific carried out by occupationist for older adults discharged from hospital for falls:

  • on the environmental dimension at the participant's home
  • on the involvement of the caregiver since they are also involved in the care of the patient
  • on the recurrence of falls and rehospitalizations in order to improve the quality of life by reassuring the elderly person when traveling
  • on limiting loss of autonomy and staying at home. The occupational therapist will entrust the caregiver with a support role. The participant will feel more involved in the participant's care (thus reducing the feeling of helplessness). His actions will allow him to strengthen his sense of competence and will prevent him from physical and psychological exhaustion.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Falls constitute the greatest cause of loss of autonomy among people aged over 65 and are often the cause of injuries leading to hospitalization and therefore significant costs. Additionally, people who have fallen before are at greater risk of falling again. People aged 65 and over with dementia fall 3 times more than people without the condition. The physical and psychological consequences of these falls in patients with dementia accelerate their loss of autonomy and ultimately lead to admission to an institution.

Occupational therapy assessment in the patient's home is an effective approach to reducing falls in the general population. Indeed, the occupational therapist's care consists of carrying out a complete assessment to highlight the links that exist between a person and their abilities, their occupations in the broad sense and the environment in which their occupations take place. The occupational therapist then proposes a personalized intervention plan (objectives and means) and follow-up which may consist of the installation of technical and technological aids, home design, advice and information for people and their caregivers.

The COTID (Community Occupational Therapist in Dementia) program is a tool for describing the stages of an occupational therapy program based on evidence (scenario-based), according to a systemic approach focused on older people with dementia and their caregivers. This has been validated and widely used in the Netherlands since 2009. Indeed, it has shown its effectiveness in terms of successfully keeping elderly people with dementia at home but also in preventing the risk of caregiver burnout. through systemic care for the couple.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female, at least 75 years old
  • Living at home (excluding nursing home or long-term care facilities)
  • Hospitalized for fall
  • Presenting major mild to moderate dementia (MMSE > 16)
  • Accompanied by a caregiver with sufficient presence to meet study procedures: at investigator's discretion at the investigator's discretion
  • Having given free, informed and written consent signed by the patient
  • Whose caregiver has given free, informed consent written and signed by him/herself
  • Affiliated or beneficiary of social security

Exclusion Criteria:

  • With serious, life-threatening pathology(ies) or in palliative care
  • Participating in an educational fall program on the theme of falls, run by an occupational therapist by an occupational therapist
  • Receiving regular occupational therapy treatment on the day of inclusion (day care daily hospitalization)
  • Participating in a clinical research protocol have an impact on the occurrence of a fall (at the investigator's discretion)
  • Not matching with the fall definition from Kellogg's definition of a fall (loss of consciousness, sudden onset of paralysis paralysis or epileptic seizure)
  • Presenting a very significant post-fall syndrome:

score of 4/4 on the "Get-up early" questionnaire

  • unable to read or write
  • Participant under legal guardianship (curator, guardian, legal protector)
  • Dementia with rapid neurocognitive degeneration degeneration with frontal and language impairment (at the investigator's discretion).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COTID program

The intervention takes place entirely in the homes of elderly people with neurocognitive disorders.

It takes an average of 10 hours of intervention per treatment, spread over 5 to 10 weeks.

The COTID program is divided into several phases:

  • Phase A: Problem definition and analysis
  • Phase B: Formulation of objectives and treatment plan
  • Phase C: Implementation of the treatment plan.
COTID is a support program for people with Alzheimer's disease, designed to help them remain at home, including their primary caregiver.
No Intervention: Routine care
Patient's needs without a COTID program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the impact of the COTID program
Time Frame: 12 months
Reference will be falls recurrence
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent falls
Time Frame: 12 months
The cumulative incidence of new falls between the two groups
12 months
Rehospitalization
Time Frame: 12 months
The rehospitalization rate
12 months
Institutional admissions
Time Frame: 12 months
The rate of institutional admissions
12 months
Loss of functional autonomy
Time Frame: 12 months
Scores: Activities of Daily Living, Instrumental Activities of Daily Living
12 months
Functional autonomy
Time Frame: 12 months
Scores: Activities of Daily Living, Occupational efficiency
12 months
Fragility profile
Time Frame: 12 months
Fragility according to Fried criteria
12 months
The caregiver's burden
Time Frame: 12 months
Zarit score comparison between the 2 arms
12 months
Coping strategies for caregivers
Time Frame: 12 months
According to the Ways of Coping Checklist
12 months
Learning retention
Time Frame: Between months 6 and months 12
According to the Ways of Coping Checklist
Between months 6 and months 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2024

Primary Completion (Estimated)

August 8, 2026

Study Completion (Estimated)

March 8, 2027

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 87RI21_0009_ErgoFallsPilote

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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