Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT04394767
Status:
TERMINATED
Last Update Posted:
2025-05-16
First Post:
2019-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Couple and Spouse Caregiver in Huntington's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "Sponsor's decision, no more inclusions made since the last extension", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2020-05-14', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "report of the experience and interactions of couple and Spouse Caregiver in Huntington's Disease", 'timeFrame': 'once time, Baseline', 'description': "Qualitative assessment: Interpretative phenomenological analysis (IPA) by semi-structured interviews to explore families representations and strategies about the patients with Huntington's Disease"}], 'secondaryOutcomes': [{'measure': "report of the experience and interactions of couple and Spouse Caregiver in Huntington's Disease", 'timeFrame': 'once time, Baseline', 'description': "Qualitative assessment : Thematic analysis by COAT (Carers Outcome Agreement Tool) during a semi-structured interviews to explore families representations and strategies about the patients with Huntington's Disease"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Huntington's disease", 'spouse caregiver', 'quality of life'], 'conditions': ['Huntington Disease']}, 'descriptionModule': {'briefSummary': 'The objectives are to better document the psychosocial status and needs of caregiver of HD patients and understand the dyad functioning, facing the disease at various stages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Huntington disease population ( patient, caregiver, spouses)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor patient :\n\n* HD, CAG \\> 36, motor UHDRS \\> 5\n* Being able to communicate with the investigator\n\nFor both spouses :\n\n* Living together since at least 5 years\n* 30 to 60 years old\n\nExclusion Criteria:\n\nFor patient :\n\n\\- Other chronic neurologic disorder\n\nFor both spouses :\n\n* Psychiatric disease\n* Unable to participate, incl read, understand and sign the informed consent'}, 'identificationModule': {'nctId': 'NCT04394767', 'acronym': 'COCOON', 'briefTitle': "Couple and Spouse Caregiver in Huntington's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': "Couple and Spouse Caregiver in Huntington's Disease", 'orgStudyIdInfo': {'id': '2018_33'}, 'secondaryIdInfos': [{'id': '2018-A02046-49', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Clémence Simonin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}, {'name': 'Pascal ANTOINE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}