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
1 other identifier
observational
233
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedStudy Start
First participant enrolled
June 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2022
CompletedSeptember 21, 2022
September 1, 2022
2 years
May 29, 2018
September 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Quantify the indirect costs associated with productivity loss for HDGECs and companions
Productivity loss is measured by annual lost wages and it is collected in the survey's employment questionnaires and WPAI
12 months
Quantify out-of-pocket expenses for HDGECs and companions
The indirect costs associated with the total annual out-of-pocket expenses.
12 months
Identify the indirect costs associated with informal care received for HDGECs
The total informal care time received during a typical week
12 months
Quantify the indirect costs associated with non-work caregiving time for companions
The indirect costs associated with the annual opportunity costs of companion
12 months
Secondary Outcomes (3)
Identify the reasons for HDGEC and companion's unemployment or underemployment
12 months
The proportion of Dual Role Companions, differentiated by HD stage of the companion
12 months
To understand traditional disease staging system based on total functional capacity (TFC)
12 months
Study Arms (6)
Early stage HDGECs
CAG length ≥ 40; DCL = 4, TFC ≥ 11
Middle stage HDGECs
CAG length ≥ 40; DCL = 4, 7 ≤ TFC ≤ 10
Late stage HDGECs
CAG length ≥ 40; DCL = 4, 0 ≤ TFC ≤ 6
Companions of early stage HDGECs
Companions of middle stage HDGECs
Companions of late stage HDGECs
Interventions
Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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).
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHDI Foundation, Inc.lead
- IQVIA Companycollaborator
Study Sites (11)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Rocky Mountain Movement Disorder, P.C.
Englewood, Colorado, 80113, United States
University of South Florida
Tampa, Florida, 33612, United States
Hereditary Neurological Disease Centre, Inc.
Wichita, Kansas, 66226, United States
Washington University
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
The Ohio State University
Columbus, Ohio, 43210, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2018
First Posted
August 14, 2018
Study Start
June 21, 2020
Primary Completion
June 21, 2022
Study Completion
June 21, 2022
Last Updated
September 21, 2022
Record last verified: 2022-09