- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03628235
HD-Charge: Indirect and Out-of-Pocket Costs of Huntington's Disease in the United States
Indirect and Out-of-Pocket Costs of Huntington's Disease in the United States
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.
This 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.
Study Overview
Detailed Description
The survey collects the following data from each HDGEC and companion:
- Participant demographics (for HDGECs and companion)
- Informal care received (for HDGECs only)
- Out of pocket HD costs (for HDGECs and companion)
- Current employment status (for HDGECs and companion)
- Non-work and work care giving time that companion spends taking care of HDGEC (for companion only)
- Work Productivity and Activity Impairment (WPAI) Questionnaire (for HDGECs and companion)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85013
- St. Joseph's Hospital and Medical Center
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Colorado
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Englewood, Colorado, United States, 80113
- Rocky Mountain Movement Disorder, P.C.
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Florida
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Tampa, Florida, United States, 33612
- University of South Florida
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Kansas
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Wichita, Kansas, United States, 66226
- Hereditary Neurological Disease Centre, Inc.
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt University Medical Center
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Texas
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Houston, Texas, United States, 77030
- University of Texas Health Science Center at Houston
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Washington
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Seattle, Washington, United States, 98115
- University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Companions: 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.
Description
Inclusion Criteria for HDGECs:
- Identified as an active participant in Enroll-HD (participants who have completed their last on site Enroll-HD visit within approximately 15 months)
- Able to provide online or written informed consent. A LAR for HDGEC can provide written consent, if applicable
- Identified as a participant with clinically diagnosed HD and has a CAG length ≥ 40
- Site PI has access to HDGEC's medical records for the purpose of completing the Resource Utilization Questionnaire
- Able to speak and understand both verbal and written English
- Has adult onset of disease (disease symptoms manifested at age 20 years or older)
- Has access to a computer/tablet/smartphone (if compatible) and internet services
Stage classification of HDGECs:
- Early stage HDGEC: CAG length ≥ 40; DCL = 4, TFC ≥ 11
- Middle stage HDGEC: CAG length ≥ 40; DCL = 4, 7 ≤ TFC ≤ 10
- Late stage HDGEC: CAG length ≥ 40; DCL = 4, 0 ≤ TFC ≤ 6
Exclusion Criteria for HDGECs:
HDGECs 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).
Inclusion criteria for companions:
- Able to provide online or written informed consent
- 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))
- Able to speak and understand both verbal and written English
- Aged 21 years or older at time of survey
- Has access to a computer/tablet/smartphone (if compatible) and internet services and has the technical skills required to complete an online survey
Exclusion Criteria for companions:
Companions 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Early stage HDGECs
CAG length ≥ 40; DCL = 4, TFC ≥ 11
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Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions
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Middle stage HDGECs
CAG length ≥ 40; DCL = 4, 7 ≤ TFC ≤ 10
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Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions
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Late stage HDGECs
CAG length ≥ 40; DCL = 4, 0 ≤ TFC ≤ 6
|
Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions
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Companions of early stage HDGECs
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Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions
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Companions of middle stage HDGECs
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Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions
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Companions of late stage HDGECs
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Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantify the indirect costs associated with productivity loss for HDGECs and companions
Time Frame: 12 months
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Productivity loss is measured by annual lost wages and it is collected in the survey's employment questionnaires and WPAI
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12 months
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Quantify out-of-pocket expenses for HDGECs and companions
Time Frame: 12 months
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The indirect costs associated with the total annual out-of-pocket expenses.
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12 months
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Identify the indirect costs associated with informal care received for HDGECs
Time Frame: 12 months
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The total informal care time received during a typical week
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12 months
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Quantify the indirect costs associated with non-work caregiving time for companions
Time Frame: 12 months
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The indirect costs associated with the annual opportunity costs of companion
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identify the reasons for HDGEC and companion's unemployment or underemployment
Time Frame: 12 months
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12 months
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The proportion of Dual Role Companions, differentiated by HD stage of the companion
Time Frame: 12 months
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12 months
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To understand traditional disease staging system based on total functional capacity (TFC)
Time Frame: 12 months
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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)
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Dementia
- Cognition Disorders
- Chorea
- Huntington Disease
Other Study ID Numbers
- C-001117-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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