NCT06237218

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress68%
Jul 2024Mar 2027

First Submitted

Initial submission to the registry

October 26, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

July 29, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2027

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

October 26, 2023

Last Update Submit

January 12, 2026

Conditions

Nervous System Diseases

Keywords

Dementia

Outcome Measures

Primary Outcomes (1)

  • Assessing the impact of the COTID program

    Reference will be falls recurrence

    12 months

Secondary Outcomes (9)

  • Recurrent falls

    12 months

  • Rehospitalization

    12 months

  • Institutional admissions

    12 months

  • Loss of functional autonomy

    12 months

  • Functional autonomy

    12 months

  • +4 more secondary outcomes

Study Arms (2)

COTID program

EXPERIMENTAL

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.

Behavioral: COTID program

Routine care

NO INTERVENTION

Patient's needs without a COTID program.

Interventions

COTID programBEHAVIORAL

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

COTID program

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Limoges

Limoges, 87042, France

RECRUITING

MeSH Terms

Conditions

Nervous System DiseasesDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Manon BOUTEAUD

CONTACT

05 55 05 65 81manon.bouteaud@chu-limoges.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double-blind randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2023

First Posted

February 1, 2024

Study Start

July 29, 2024

Primary Completion (Estimated)

August 8, 2026

Study Completion (Estimated)

March 8, 2027

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)