Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT03628235
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2018-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HD-Charge: Indirect and Out-of-Pocket Costs of Huntington's Disease in the United States
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-19', 'studyFirstSubmitDate': '2018-05-29', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantify the indirect costs associated with productivity loss for HDGECs and companions', 'timeFrame': '12 months', 'description': "Productivity loss is measured by annual lost wages and it is collected in the survey's employment questionnaires and WPAI"}, {'measure': 'Quantify out-of-pocket expenses for HDGECs and companions', 'timeFrame': '12 months', 'description': 'The indirect costs associated with the total annual out-of-pocket expenses.'}, {'measure': 'Identify the indirect costs associated with informal care received for HDGECs', 'timeFrame': '12 months', 'description': 'The total informal care time received during a typical week'}, {'measure': 'Quantify the indirect costs associated with non-work caregiving time for companions', 'timeFrame': '12 months', 'description': 'The indirect costs associated with the annual opportunity costs of companion'}], 'secondaryOutcomes': [{'measure': "Identify the reasons for HDGEC and companion's unemployment or underemployment", 'timeFrame': '12 months'}, {'measure': 'The proportion of Dual Role Companions, differentiated by HD stage of the companion', 'timeFrame': '12 months'}, {'measure': 'To understand traditional disease staging system based on total functional capacity (TFC)', 'timeFrame': '12 months', 'description': 'For HDGECs and Companions: Understand how the traditional disease staging system, based on the TFC score, relates to a staging system based on resource utilization questionnaire and comorbid conditions developed in Divino et al. (2013)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['online survey', 'indirect costs', 'out-of-pocket costs', 'HD', "Huntington's disease", 'companions', 'Enroll-HD'], 'conditions': ["Huntington's Disease"]}, 'descriptionModule': {'briefSummary': "Huntington's disease (HD) is a rare, inherited and progressive neurodegenerative disorder for which hallmark symptoms include movement disorders, loss of cognitive faculties and psychiatric disturbances. With the progression of the disease, patients require increasing level of medical care, caregiver support, and long-term care, which lead to substantial burden of illness. Very little data are available on the direct or indirect costs for HD. The direct medical costs of HD in the US have been summarized from retrospective commercial and Medicaid claims data analysis. The indirect and out-of-pocket costs of HD in the US have not been quantified. This study will help to bridge these gaps.\n\nThis study is a single-assessment, cross-sectional online survey administered to Huntington disease gene expansion carriers (HDGECs) and companions of HDGECs by HD stage to understand the indirect and out-of-pocket costs of Huntington's disease in the US.", 'detailedDescription': 'The survey collects the following data from each HDGEC and companion:\n\n1. Participant demographics (for HDGECs and companion)\n2. Informal care received (for HDGECs only)\n3. Out of pocket HD costs (for HDGECs and companion)\n4. Current employment status (for HDGECs and companion)\n5. Non-work and work care giving time that companion spends taking care of HDGEC (for companion only)\n6. Work Productivity and Activity Impairment (WPAI) Questionnaire (for HDGECs and companion)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "HDGECs: Participant in Enroll-HD with clinically diagnosed HD and a cytosine, adenine, guanine (CAG) length ≥ 40, who meets the protocol inclusion criteria and none of the exclusion criteria.\n\nCompanions: Primary provider (unpaid) of supportive care for an HDGEC (this HDGEC must be an active participant of Enroll-HD Study, have a CAG ≥ 40, have an adult onset of disease (disease symptoms manifested at age 20 years or older), and a DCL=4)), who meets the protocol's companion inclusion criteria and none of the exclusion criteria.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for HDGECs:\n\n* Identified as an active participant in Enroll-HD (participants who have completed their last on site Enroll-HD visit within approximately 15 months)\n* Able to provide online or written informed consent. A LAR for HDGEC can provide written consent, if applicable\n* Identified as a participant with clinically diagnosed HD and has a CAG length ≥ 40\n* Site PI has access to HDGEC's medical records for the purpose of completing the Resource Utilization Questionnaire\n* Able to speak and understand both verbal and written English\n* Has adult onset of disease (disease symptoms manifested at age 20 years or older)\n* Has access to a computer/tablet/smartphone (if compatible) and internet services\n\nStage classification of HDGECs:\n\n1. Early stage HDGEC: CAG length ≥ 40; DCL = 4, TFC ≥ 11\n2. Middle stage HDGEC: CAG length ≥ 40; DCL = 4, 7 ≤ TFC ≤ 10\n3. Late stage HDGEC: CAG length ≥ 40; DCL = 4, 0 ≤ TFC ≤ 6\n\nExclusion Criteria for HDGECs:\n\nHDGECs will be excluded from the study if they have significant cognitive or any other impairment sufficient to interfere with study associated tasks as judged by the Site PI or Site PI's designee (exceptions will be made if a companion/LAR completes the survey on their behalf).\n\nInclusion criteria for companions:\n\n* Able to provide online or written informed consent\n* Identified as the primary provider (unpaid) of supportive care of an HDGEC (HDGEC must be an Enroll-HD participant and have a CAG length ≥ 40 and have adult onset of disease (disease symptoms manifested at age 20 years or older))\n* Able to speak and understand both verbal and written English\n* Aged 21 years or older at time of survey\n* Has access to a computer/tablet/smartphone (if compatible) and internet services and has the technical skills required to complete an online survey\n\nExclusion Criteria for companions:\n\nCompanions will be excluded from the study if they are identified as paid or salaried caregivers; however, the HDGECs for whom they care may still be included in the study."}, 'identificationModule': {'nctId': 'NCT03628235', 'briefTitle': "HD-Charge: Indirect and Out-of-Pocket Costs of Huntington's Disease in the United States", 'organization': {'class': 'OTHER', 'fullName': 'CHDI Foundation, Inc.'}, 'officialTitle': "Indirect and Out-of-Pocket Costs of Huntington's Disease in the United States", 'orgStudyIdInfo': {'id': 'C-001117-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early stage HDGECs', 'description': 'CAG length ≥ 40; DCL = 4, TFC ≥ 11', 'interventionNames': ['Behavioral: Online survey']}, {'label': 'Middle stage HDGECs', 'description': 'CAG length ≥ 40; DCL = 4, 7 ≤ TFC ≤ 10', 'interventionNames': ['Behavioral: Online survey']}, {'label': 'Late stage HDGECs', 'description': 'CAG length ≥ 40; DCL = 4, 0 ≤ TFC ≤ 6', 'interventionNames': ['Behavioral: Online survey']}, {'label': 'Companions of early stage HDGECs', 'interventionNames': ['Behavioral: Online survey']}, {'label': 'Companions of middle stage HDGECs', 'interventionNames': ['Behavioral: Online survey']}, {'label': 'Companions of late stage HDGECs', 'interventionNames': ['Behavioral: Online survey']}], 'interventions': [{'name': 'Online survey', 'type': 'BEHAVIORAL', 'description': "Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions", 'armGroupLabels': ['Companions of early stage HDGECs', 'Companions of late stage HDGECs', 'Companions of middle stage HDGECs', 'Early stage HDGECs', 'Late stage HDGECs', 'Middle stage HDGECs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St. Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Movement Disorder, P.C.', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '66226', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Hereditary Neurological Disease Centre, Inc.', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98115', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHDI Foundation, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'IQVIA Company', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}