Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT06237218
Status:
RECRUITING
Last Update Posted:
2024-12-16
First Post:
2023-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind randomised controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-03-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2024-01-23', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the impact of the COTID program', 'timeFrame': '12 months', 'description': 'Reference will be falls recurrence'}], 'secondaryOutcomes': [{'measure': 'Recurrent falls', 'timeFrame': '12 months', 'description': 'The cumulative incidence of new falls between the two groups'}, {'measure': 'Rehospitalization', 'timeFrame': '12 months', 'description': 'The rehospitalization rate'}, {'measure': 'Institutional admissions', 'timeFrame': '12 months', 'description': 'The rate of institutional admissions'}, {'measure': 'Loss of functional autonomy', 'timeFrame': '12 months', 'description': 'Scores: Activities of Daily Living, Instrumental Activities of Daily Living'}, {'measure': 'Functional autonomy', 'timeFrame': '12 months', 'description': 'Scores: Activities of Daily Living, Occupational efficiency'}, {'measure': 'Fragility profile', 'timeFrame': '12 months', 'description': 'Fragility according to Fried criteria'}, {'measure': "The caregiver's burden", 'timeFrame': '12 months', 'description': 'Zarit score comparison between the 2 arms'}, {'measure': 'Coping strategies for caregivers', 'timeFrame': '12 months', 'description': 'According to the Ways of Coping Checklist'}, {'measure': 'Learning retention', 'timeFrame': 'Between months 6 and months 12', 'description': 'According to the Ways of Coping Checklist'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dementia'], 'conditions': ['Nervous System Diseases']}, 'descriptionModule': {'briefSummary': "This project will enable optimization of specific carried out by occupationist for older adults discharged from hospital for falls:\n\n* on the environmental dimension at the participant's home\n* on the involvement of the caregiver since they are also involved in the care of the patient\n* on the recurrence of falls and rehospitalizations in order to improve the quality of life by reassuring the elderly person when traveling\n* 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.", 'detailedDescription': "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.\n\nOccupational 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, at least 75 years old\n* Living at home (excluding nursing home or long-term care facilities)\n* Hospitalized for fall\n* Presenting major mild to moderate dementia (MMSE \\> 16)\n* Accompanied by a caregiver with sufficient presence to meet study procedures: at investigator\'s discretion at the investigator\'s discretion\n* Having given free, informed and written consent signed by the patient\n* Whose caregiver has given free, informed consent written and signed by him/herself\n* Affiliated or beneficiary of social security\n\nExclusion Criteria:\n\n* With serious, life-threatening pathology(ies) or in palliative care\n* Participating in an educational fall program on the theme of falls, run by an occupational therapist by an occupational therapist\n* Receiving regular occupational therapy treatment on the day of inclusion (day care daily hospitalization)\n* Participating in a clinical research protocol have an impact on the occurrence of a fall (at the investigator\'s discretion)\n* Not matching with the fall definition from Kellogg\'s definition of a fall (loss of consciousness, sudden onset of paralysis paralysis or epileptic seizure)\n* Presenting a very significant post-fall syndrome:\n\nscore of 4/4 on the "Get-up early" questionnaire\n\n* unable to read or write\n* Participant under legal guardianship (curator, guardian, legal protector)\n* Dementia with rapid neurocognitive degeneration degeneration with frontal and language impairment (at the investigator\'s discretion).'}, 'identificationModule': {'nctId': 'NCT06237218', 'acronym': 'ErgoFalls', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': '87RI21_0009_ErgoFallsPilote'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COTID program', 'description': 'The intervention takes place entirely in the homes of elderly people with neurocognitive disorders.\n\nIt takes an average of 10 hours of intervention per treatment, spread over 5 to 10 weeks.\n\nThe COTID program is divided into several phases:\n\n* Phase A: Problem definition and analysis\n* Phase B: Formulation of objectives and treatment plan\n* Phase C: Implementation of the treatment plan.', 'interventionNames': ['Behavioral: COTID program']}, {'type': 'NO_INTERVENTION', 'label': 'Routine care', 'description': "Patient's needs without a COTID program."}], 'interventions': [{'name': 'COTID program', 'type': 'BEHAVIORAL', 'description': "COTID is a support program for people with Alzheimer's disease, designed to help them remain at home, including their primary caregiver.", 'armGroupLabels': ['COTID program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87042', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Manon BOUTEAUD', 'role': 'CONTACT', 'email': 'manon.bouteaud@chu-limoges.fr', 'phone': '05 55 05 65 81'}], 'facility': 'Chu Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}], 'centralContacts': [{'name': 'Manon BOUTEAUD', 'role': 'CONTACT', 'email': 'manon.bouteaud@chu-limoges.fr', 'phone': '05 55 05 65 81'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}