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FuRST 2.0 Cognitive Pre-Testing

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Disease Information

Descriptive Information
Brief Title † FuRST 2.0 Cognitive Pre-Testing
Official Title † FuRST 2.0: Cognitive Pre-Testing Study for a New Functional Rating Scale for Use in Huntington's Disease
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
Study Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † Participants' comprehension of the FuRST 2.0 rating scale measured by qualitative analysis
Secondary Outcome Measure † The difference between the ratings of the HDGEC participants and the companions measured by the FuRST 2.0 rating scale
Condition † Huntington's Disease
Intervention † BehavioralFuRST 2.0
Study Arms / Comparison Groups Pre-Manifest HDGEC Participant Early-Manifest HDGEC Participant Corresponding HDGEC participant Companion
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Behavioral
Estimated Enrollment † 80
Start Date † February 28, 2017
Completion Date December 2017
Primary Completion Date November 2017
Eligibility Criteria † Main criteria for inclusion: 1. HDGEC participant must be a participant in Enroll-HD (NCT No.: NCT01574053) 2. At least 18 years of age 3. Must be fluent in English and had his primary education in English 4. Must be willing and able to provide written informed consent Pre-Manifest HDGECs Criteria 1-4, and: 1. CAG length greater than or equal to 40 2. Disease Burden Score greater than or equal to 250 (calculated by the equation: [CAGn-35.5] X age) 3. UHDRS Diagnostic Confidence Level (DCL)
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Rebecca Fuller, 609-945-9605, rebecca.fuller@chdifoundation.org
Location Countries † Canada
Administrative Information
NCT ID † NCT02881931
Organization ID C-000316
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † CHDI Foundation, Inc.
Collaborators †† Dr. Glenn T. Stebbins (Rush University Medical Center )
Investigators † : ,
Information Provided By
Verification Date April 2017
First Received Date † August 12, 2016
Last Updated Date April 3, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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