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Trial record 7 of 183 for:    "huntington disease"

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

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ClinicalTrials.gov Identifier: NCT03628235
Recruitment Status : Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
IQVIA
Information provided by (Responsible Party):
CHDI Foundation, Inc.

Brief Summary:

Huntington's disease (HD) is a progressive, rare 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 a 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.


Condition or disease Intervention/treatment
Huntington's Disease Behavioral: Online survey

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. Work Productivity and Activity Impairment (WPAI) Questionnaire Work time due to HD/caregiving (for HDGECs and companion)
  6. Non-work time spent on caregiving (for companion only)

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Indirect and Out-of-Pocket Costs of Huntington's Disease in the United States
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Early stage HDGECs
CAG length ≥ 40; DCL = 4, TFC ≥ 11
Behavioral: Online survey
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
Behavioral: Online survey
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
Behavioral: Online survey
Online survey to capture indirect and out of pocket costs of Huntington's Disease in HDGECs and companions

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

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

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




Primary Outcome Measures :
  1. Quantify the indirect costs associated with productivity loss for HDGECs and companions [ Time Frame: 30 months ]
    Productivity loss is measured by annual lost wages and it is collected in the survey's employment questionnaires and WPAI

  2. Quantify out-of-pocket expenses for HDGECs and companions [ Time Frame: 30 months ]
    The indirect costs associated with the total annual out-of-pocket expenses.

  3. Identify the indirect costs associated with informal care received for HDGECs [ Time Frame: 30 months ]
    The total informal care time received during a typical week

  4. Quantify the indirect costs associated with non-work caregiving time for companions [ Time Frame: 30 months ]
    The indirect costs associated with the annual opportunity costs of companion


Secondary Outcome Measures :
  1. Identify the reasons for HDGEC and companion's unemployment or underemployment [ Time Frame: 30 months ]
  2. To understand traditional disease staging system [ Time Frame: 30 months ]
    For HDGECs and Companions: Understand how the traditional disease staging system, based on the total functional capacity (TFC) score, relates to a staging system based on resource utilization and comorbid conditions developed in Divino et al. (2013)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628235


Contacts
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Contact: Jia Luo, MD, MS 609-945-9627 jia.luo@chdifoundation.org
Contact: Prachi Dalal, MS, CCRP 609-945-9608 prachi.dalal@chdifoundation.org

Sponsors and Collaborators
CHDI Foundation, Inc.
IQVIA

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Responsible Party: CHDI Foundation, Inc.
ClinicalTrials.gov Identifier: NCT03628235     History of Changes
Other Study ID Numbers: C-001117-1
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHDI Foundation, Inc.:
online survey
indirect costs
out-of-pocket costs
HD
Huntington's disease
companions
Enroll-HD

Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders