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FuRST 2.0 Cognitive Pre-testing - Round 2

NCT03709173 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2019-10-29

No results posted yet for this study

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

BEHAVIORAL

FuRST 2.0

Round 2 of cognitive pre-testing for a new functional rating scale

Sponsors & Collaborators

  • Dr. Glenn T. Stebbins (Rush University Medical Center )

    collaborator UNKNOWN

  • Dr. Nancy LaPelle

    collaborator UNKNOWN

  • CHDI Foundation, Inc.

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-02
Primary Completion
2019-10-25
Completion
2019-10-25

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03709173 on ClinicalTrials.gov