HD-Charge: Indirect and Out-of-Pocket Costs of Huntington's Disease in the United States

NCT ID: NCT03628235

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 233 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-21
• Study Completion Date: 2022-06-21

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.

Detailed Description

The survey collects the following data from each HDGEC and companion:

1. Participant demographics (for HDGECs and companion)

2. Informal care received (for HDGECs only)

3. Out of pocket HD costs (for HDGECs and companion)

4. Current employment status (for HDGECs and companion)

5. Non-work and work care giving time that companion spends taking care of HDGEC (for companion only)

6. Work Productivity and Activity Impairment (WPAI) Questionnaire (for HDGECs and companion)

Conditions

Huntington's Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Early stage HDGECs

CAG length ≥ 40; DCL = 4, TFC ≥ 11

Online survey

Intervention Type: BEHAVIORAL

Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions

Middle stage HDGECs

CAG length ≥ 40; DCL = 4, 7 ≤ TFC ≤ 10

Online survey

Intervention Type: BEHAVIORAL

Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions

Late stage HDGECs

CAG length ≥ 40; DCL = 4, 0 ≤ TFC ≤ 6

Online survey

Intervention Type: BEHAVIORAL

Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions

Companions of early stage HDGECs

Online survey

Intervention Type: BEHAVIORAL

Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions

Companions of middle stage HDGECs

Online survey

Intervention Type: BEHAVIORAL

Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions

Companions of late stage HDGECs

Online survey

Intervention Type: BEHAVIORAL

Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions

Interventions

Online survey

Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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:

1. Early stage HDGEC: CAG length ≥ 40; DCL = 4, TFC ≥ 11

2. Middle stage HDGEC: CAG length ≥ 40; DCL = 4, 7 ≤ TFC ≤ 10

3. Late stage HDGEC: CAG length ≥ 40; DCL = 4, 0 ≤ TFC ≤ 6

• 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

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).

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IQVIA Company

UNKNOWN

Sponsor Role: collaborator

CHDI Foundation, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Rocky Mountain Movement Disorder, P.C.

Englewood, Colorado, United States

University of South Florida

Tampa, Florida, United States

Hereditary Neurological Disease Centre, Inc.

Wichita, Kansas, United States

Washington University

St Louis, Missouri, United States

Columbia University Medical Center

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

C-001117-1

Identifier Type: -

Identifier Source: org_study_id