MedPath

FuRST 2.0 Cognitive Pre-Testing

Completed
Conditions
Huntington's Disease
Registration Number
NCT02881931
Lead Sponsor
CHDI Foundation, Inc.
Brief Summary

The FuRST 2.0 scale is being developed as a Patient Reported Outcome (PRO) with information coming directly from the Huntington's Disease Gene Expansion Carrier (HDGEC) and companion through self-report. The purpose of this study is to identify real or potential comprehension or usage problems with questionnaire items or response options. Through a process of structured cognitive de-briefing with HDGEC participants and companions, independently, followed by qualitative analysis, the final phrasing of the individual items and response options for the scale will be generated. Depending on the results of the first round of cognitive pre-testing, additional rounds of cognitive pre-testing may be required.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
75
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Participants' comprehension of the FuRST 2.0 rating scale measured by qualitative analysis8 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.

Secondary Outcome Measures
NameTimeMethod
The difference between the ratings of the HDGEC participants and the companions measured by the FuRST 2.0 rating scale8 months

The secondary outcome measure will be evaluated using the Kolmogorov-Smirnov test

Trial Locations

Locations (4)

Rocky Mountain Movement Disorders Center, P.C.

🇺🇸

Englewood, Colorado, United States

Hereditary Neurology Disease Centre, Inc.

🇺🇸

Wichita, Kansas, United States

Columbia University

🇺🇸

New York, New York, United States

CENTRE FOR MOVEMENT DISORDERS (Neuropharm Consulting)

🇨🇦

Toronto, Ontario, Canada

Rocky Mountain Movement Disorders Center, P.C.
🇺🇸Englewood, Colorado, United States

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