FuRST 2.0 Cognitive Pre-testing - Round 2

Study Overview
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Brief Summary
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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.

Official Title
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FuRST 2.0: Cognitive Pre-testing for a New Functional Rating Scale for Use in Huntington's Disease - Round 2

Conditions
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Huntington Disease

Intervention / Treatment
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* Behavioral: FuRST 2.0


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Premanifest HDGEC participants<br> | Behavioral: FuRST 2.0<br>* Round 2 of cognitive pre-testing for a new functional rating scale<br>|
| Early-manifest HDGEC participants<br> | Behavioral: FuRST 2.0<br>* Round 2 of cognitive pre-testing for a new functional rating scale<br>|
| Companions of Premanifest HDGEC<br> | Behavioral: FuRST 2.0<br>* Round 2 of cognitive pre-testing for a new functional rating scale<br>|
| Companions of Early-manifest<br> | Behavioral: FuRST 2.0<br>* Round 2 of cognitive pre-testing for a new functional rating scale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant's comprehension of the FuRST 2.0 rating scale measured by qualitative analysis. | 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. | 7 months |