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

Huntington's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628235
• Other study ID #: C-001117-1
• Status: Completed
• Start date: June 21, 2020
• Est. completion date: June 21, 2022

Study information

• Verified date: September 2022
• Source: CHDI Foundation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: June 21, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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:

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 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.

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

Intervention

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

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	Rocky Mountain Movement Disorder, P.C.	Englewood	Colorado
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington
United States	University of South Florida	Tampa	Florida
United States	Hereditary Neurological Disease Centre, Inc.	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
CHDI Foundation, Inc.	IQVIA Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Quantify out-of-pocket expenses for HDGECs and companions	The indirect costs associated with the total annual out-of-pocket expenses.	12 months
Primary	Identify the indirect costs associated with informal care received for HDGECs	The total informal care time received during a typical week	12 months
Primary	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	Identify the reasons for HDGEC and companion's unemployment or underemployment		12 months
Secondary	The proportion of Dual Role Companions, differentiated by HD stage of the companion		12 months
Secondary	To understand traditional disease staging system based on total functional capacity (TFC)	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)	12 months