Nervous System DiseasesErgoFallsNCT06237218
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
A study testing COTID program in people with Nervous System Diseases, run by University Hospital, Limoges at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nervous System Diseases
- What is being tested?
- COTID program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2024to 8 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Limoges
Limoges, 87042
Manon BOUTEAUD, 05 55 05 65 81, manon.bouteaud@chu-limoges.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Nervous System Diseases
- Being tested
- COTID program
- Keywords
- Dementia
- Medical subject headings
- Nervous System Diseases, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COTID programBehavioural
COTID is a support program for people with Alzheimer's disease, designed to help them remain at home, including their primary caregiver.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: COTID program |
| Routine care | No intervention | Patient's needs without a COTID program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the impact of the COTID program
Reference will be falls recurrence
Measured: 12 months
Secondary outcomes (9)
Recurrent falls
The cumulative incidence of new falls between the two groups
Measured: 12 months
Rehospitalization
The rehospitalization rate
Measured: 12 months
Institutional admissions
The rate of institutional admissions
Measured: 12 months
Loss of functional autonomy
Scores: Activities of Daily Living, Instrumental Activities of Daily Living
Measured: 12 months
Functional autonomy
Scores: Activities of Daily Living, Occupational efficiency
Measured: 12 months
Fragility profile
Fragility according to Fried criteria
Measured: 12 months
The caregiver's burden
Zarit score comparison between the 2 arms
Measured: 12 months
Coping strategies for caregivers
According to the Ways of Coping Checklist
Measured: 12 months
Learning retention
According to the Ways of Coping Checklist
Measured: Between months 6 and months 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start29 Jul 2024
- Primary completion8 Aug 2026 (estimated)
- Study completion8 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nervous System DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomised controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237218
- Sponsor's protocol ID
- 87RI21_0009_ErgoFallsPilote
- Acronym
- ErgoFalls
- Status last verified
- Jan 2026
- First submitted
- 26 Oct 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06237218
- Acronym / sponsor ID
- ErgoFalls / 87RI21_0009_ErgoFallsPilote
- Conditions
- Nervous System Diseases
- Keywords
- Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 8 Aug 2026 (estimated)
- Study completion
- 8 Mar 2027 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| COTID program | Experimental | Behavioral: COTID programThe 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. |
| Routine care | No intervention | –Patient's needs without a COTID program. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COTID programCOTID is a support program for people with Alzheimer's disease, designed to help them remain at home, including their primary caregiver. | Behavioural | COTID program |
Primary outcome
Assessing the impact of the COTID program
Time frame: 12 months
Reference will be falls recurrence
9 secondary outcomes
Recurrent falls
Time frame: 12 months
Rehospitalization
Time frame: 12 months
Institutional admissions
Time frame: 12 months
Loss of functional autonomy
Time frame: 12 months
Functional autonomy
Time frame: 12 months
Fragility profile
Time frame: 12 months
The caregiver's burden
Time frame: 12 months
Coping strategies for caregivers
Time frame: 12 months
Learning retention
Time frame: Between months 6 and months 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COTID program in people with Nervous System Diseases, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon BOUTEAUD (05 55 05 65 81, manon.bouteaud@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the impact of the COTID program (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.