Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-03-17 @ 7:43 AM
Study NCT ID:
NCT06343220
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2024-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}, {'id': 'C563757', 'term': 'Charcot-Marie-Tooth Disease, Axonal, Type 2A2'}], '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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2024-03-26', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examine awareness', 'timeFrame': 'December 2024', 'description': "To examine prospective research participants' awareness, willingness, and ability to participate in clinical research for HD."}, {'measure': 'Provide the HD research community with the insight.', 'timeFrame': 'December 2024', 'description': 'Provide the HD research community with insight to design clinical studies and trials in the future.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HSG, HD, Observational'], 'conditions': ['Huntington Disease']}, 'descriptionModule': {'briefSummary': 'The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted.', 'detailedDescription': "The Project AWARE 2.0 Survey will be offered to HD families via HSG's online platform called myHDstory®. The survey will obtain input and knowledge about their feelings, attitudes, and beliefs concerning clinical research and the process by which HD studies are communicated and conducted. Project AWARE 2.0 is intended to provide the HD research community with the insight and tools to help (a) improve prospective research participants' awareness, willingness, and ability to participate in clinical research for HD; and (b) design clinical studies and trials in the future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Must either have HD or be at risk for having HD.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must either have HD or be at risk for having HD\n* Participants must be 18 years of age or older\n* Participants must live in the United States\n* Inclusion of participants will not be based on race, gender, or ethnicity.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06343220', 'briefTitle': 'Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research', 'organization': {'class': 'NETWORK', 'fullName': 'Huntington Study Group'}, 'officialTitle': 'Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research', 'orgStudyIdInfo': {'id': 'AWARE 2.0'}}, 'contactsLocationsModule': {'locations': [{'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Huntington Study Group', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Amy Brown, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HSG'}]}, 'ipdSharingStatementModule': {'timeFrame': '2024', 'ipdSharing': 'YES', 'description': 'The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted. Answers to these questions will provide valuable information to the HD research community when designing and conducting drug trials and observational studies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huntington Study Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Roche Products Limited', 'class': 'UNKNOWN'}, {'name': 'Neurotargeting LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}