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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06237218
Other study ID # 87RI21_0009_ErgoFallsPilote
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 8, 2024
Est. completion date March 8, 2027

Study information

Verified date October 2023
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 76
Est. completion date March 8, 2027
Est. primary completion date August 8, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 75 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
COTID program
COTID is a support program for people with Alzheimer's disease, designed to help them remain at home, including their primary caregiver.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Limoges

Outcome

Type Measure Description Time frame Safety issue
Primary Assessing the impact of the COTID program Reference will be falls recurrence 12 months
Secondary Recurrent falls The cumulative incidence of new falls between the two groups 12 months
Secondary Rehospitalization The rehospitalization rate 12 months
Secondary Institutional admissions The rate of institutional admissions 12 months
Secondary Loss of functional autonomy Scores: Activities of Daily Living, Instrumental Activities of Daily Living 12 months
Secondary Functional autonomy Scores: Activities of Daily Living, Occupational efficiency 12 months
Secondary Fragility profile Fragility according to Fried criteria 12 months
Secondary The caregiver's burden Zarit score comparison between the 2 arms 12 months
Secondary Coping strategies for caregivers According to the Ways of Coping Checklist 12 months
Secondary Learning retention According to the Ways of Coping Checklist Between months 6 and months 12
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