Huntington Disease
Conditions
Brief summary
The study is a single, cross-sectional cognitive interview of FuRST 2.0, functional rating scale, administered to forty Huntington's Disease Gene Expansion Carriers (HDGECs) and potentially, their companions (the companion's participation is optional in this study). The scale will be tested as a patient reported outcome (PRO) in that the information will come directly from the HDGEC participant or the HDGEC participant together with his/her companion through self-report. The purpose is to identify real or potential comprehension or usage problems with scale items, response options, instructions and disclaimer statement, which are all components of the FuRST 2.0 scale. Through a structured cognitive interview with the HDGEC participants or the HDGEC participants together with their companions, followed by qualitative analysis, the final phrasing of the individual scale items, response options, instructions and disclaimer statement for the scale will be generated. Depending on the results of this study, an additional round of cognitive pre-testing may be required in a separate study.
Interventions
BEHAVIORALFuRST 2.0
Round 2 of cognitive pre-testing for a new functional rating scale
Sponsors
Dr. Glenn T. Stebbins (Rush University Medical Center )
Dr. Nancy LaPelle
CHDI Foundation, Inc.
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Premanifest HDGECs: * Identified as an active participant in Enroll-HD (participants who have completed their last onsite Enroll-HD visit within approximately 15 months) * At least 18 years of age * Fluent in English and had his/her primary education in English * Able and willing to provide critical feedback (per site PI or site PI's designee discretion) * Willing and able to provide written informed consent * Cytosine, Adenine, Guanine (CAG) length ≥ 40 * Disease burden score (DBS) ≥ 250 * Diagnostic confidence level (DCL) ≤ 3 Inclusion Criteria for Early-manifest HDGECs: * Identified as an active participant in Enroll-HD (participants who have completed their last onsite Enroll-HD visit within approximately 15 months) * At least 18 years of age * Fluent in English and had his/her primary education in English * Able and willing to provide critical feedback (per site PI or site PI's designee discretion) * Willing and able to provide written informed consent * CAG length ≥ 36 * DCL= 4 * Total Functional Capacity (TFC) ≥11 Inclusion Criteria for a Companion of an HDGEC * At least 18 years of age * Fluent in English and had his/her primary education in English * In his/her opinion, has sufficient interaction and knowledge of the HDGEC participant's capabilities and daily activities * Is acceptable to the HDGEC participant and the site PI or site PI's designee * Willing and able to provide written informed consent
Exclusion criteria
for an HDGEC/a companion of HDGEC: * Significant cognitive or any other impairment sufficient to interfere with study associated tasks as judged by the site PI or the site PI's designee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant's comprehension of the FuRST 2.0 rating scale measured by qualitative analysis. | 7 months | The primary assessment will use qualitative analysis of the cognitive interview to determine the usability of the FuRST 2.0 scale in the HD population. Note: The instructions, items, response options and disclaimer statement are all part of the FuRST 2.0 scale. |
Countries
Canada, United States
Outcome results
None listed