Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT02218567
Status:
TERMINATED
Last Update Posted:
2020-10-22
First Post:
2014-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioural Problems in Huntington Disease : Analysis and Enhancement of Caregiver and Patient Experience
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007406', 'term': 'Interview, Psychological'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D011580', 'term': 'Psychological Techniques'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'inclusion difficult', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2014-08-14', 'studyFirstSubmitQcDate': '2014-08-14', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Huntington's Disease health-related Quality of Life questionnaire", 'timeFrame': 'Baseline', 'description': 'The primary outcome is to find a list of caregiver competences necessary to prevent and adapt to behavioural problems of Huntington Disease patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Huntington Disease']}, 'descriptionModule': {'briefSummary': 'The study hypothesis is that caregivers experience allows them to develop a lot of knowledge and know-how about behavioural problems in Huntington Disease and its consequences. The purpose of this study is to collect, describe and analyse caregivers experience in order to find and enhance their knowledge related to the adaptation to behavioural problems of Huntington Disease patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For patients:\n\n * Patients with Huntington Disease declared\n * Huntington Disease diagnosed with abnormal number of CAG repeats: 38 \\< nucleotide expansion (CAG)\n * Total Functional Capacity ≥ 7\n * Patients living with a caregiver\n * Aged 18 years and above\n * Subject gave its written consent\n* For caregivers :\n\n * No risk of caregiver having Huntington disease\n * Aged 18 years and above\n * Subject gave its written consent\n\nExclusion Criteria:\n\n* For patients:\n\n * Patient who do not live with a caregiver\n * No national health insurance affiliation\n * Being under guardianship\n* For caregivers :\n\n * Caregiver at risk for Huntington Disease\n * No national health insurance affiliation\n * Being under guardianship'}, 'identificationModule': {'nctId': 'NCT02218567', 'acronym': 'HUNTEXPERT', 'briefTitle': 'Behavioural Problems in Huntington Disease : Analysis and Enhancement of Caregiver and Patient Experience', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'orgStudyIdInfo': {'id': '2014-A00327-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients', 'interventionNames': ['Behavioral: psychological interview', 'Behavioral: psychological tests', 'Other: Motor evaluation', 'Behavioral: Behavioral evaluation', 'Behavioral: cognitive tests']}, {'type': 'OTHER', 'label': 'Caregivers', 'interventionNames': ['Behavioral: questionnaire qualilty of life', 'Behavioral: psychological interview']}], 'interventions': [{'name': 'questionnaire qualilty of life', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Caregivers']}, {'name': 'psychological interview', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Caregivers', 'Patients']}, {'name': 'psychological tests', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Patients']}, {'name': 'Motor evaluation', 'type': 'OTHER', 'armGroupLabels': ['Patients']}, {'name': 'Behavioral evaluation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Patients']}, {'name': 'cognitive tests', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'state': 'Maine Et Loire', 'country': 'France', 'facility': 'University Hospital of Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}