FuRST 2.0 Cognitive Pre-testing - Round 2

Completed

• Conditions: Huntington Disease

• Registration Number: NCT03709173
• Lead Sponsor: CHDI Foundation, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Study Start: 2019-08-02
• Status Verified: 2019-10
• Primary Completion: 2019-10-25
• Study Completion: 2019-10-25
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

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

Hereditary Neurological Disease Centre, Inc.; 🇺🇸 Wichita, Kansas, United States

Columbia University; 🇺🇸 New York, New York, United States

Centre for Movement Disorders (Neuropharm Consulting); 🇨🇦 Toronto, Ontario, Canada