NCT03709173

FuRST 2.0 Cognitive Pre-testing - Round 2

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: CHDI Foundation, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
BEHAVIORAL	FuRST 2.0	Round 2 of cognitive pre-testing for a new functional rating scale

Timeline

• Start date: 2019-08-02
• Primary completion: 2019-10-25
• Completion: 2019-10-25
• First posted: 2018-10-17
• Last updated: 2019-10-29

Locations

4 sites across 2 countries: United States, Canada