- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06237218
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)
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
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manon BOUTEAUD
- Phone Number: 05 55 05 65 81
- Email: manon.bouteaud@chu-limoges.fr
Study Locations
-
-
-
Limoges, France, 87042
- Recruiting
- CHU Limoges
-
Contact:
- Manon BOUTEAUD
- Phone Number: 05 55 05 65 81
- Email: manon.bouteaud@chu-limoges.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
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
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 87RI21_0009_ErgoFallsPilote
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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