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

Status: Completed
Location: See all (11) locations...
Intervention Type: Behavioral
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: No
View:

• 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

• 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

Locations
United States
Arizona
St. Joseph's Hospital and Medical Center
Phoenix
Colorado
Rocky Mountain Movement Disorder, P.C.
Englewood
Florida
University of South Florida
Tampa
Kansas
Hereditary Neurological Disease Centre, Inc.
Wichita
Missouri
Washington University
Saint Louis
New York
Columbia University Medical Center
New York
Ohio
The Ohio State University
Columbus
Pennsylvania
University of Pittsburgh
Pittsburgh
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
University of Texas Health Science Center at Houston
Houston
Washington
University of Washington
Seattle
Time Frame
Start Date: June 21, 2020
Completion Date: June 21, 2022
Participants
Target number of participants: 233
Treatments
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
Authors
Daniel O. Claassen, Hiral Shah, Nicki Niemann, Rajeev Kumar, Joel S. Perlmutter, William Mallonee, Ali Samii, Karen Marder, Sandra Kostyk, Valerie Suski, Stephen Aradi, Anny Lin, Sanchez-Ramos Juan, Erin Furr Stimming
Sponsors
Leads: CHDI Foundation, Inc.
Collaborators: IQVIA Company

This content was sourced from clinicaltrials.gov

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