FuRST 2.0 Cognitive Pre-Testing
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pre-Manifest HDGEC Participant
|
Behavioral: FuRST 2.0
Cognitive Pre-testing of new Functional Rating Scale
|
| Early-Manifest HDGEC Participant
|
Behavioral: FuRST 2.0
Cognitive Pre-testing of new Functional Rating Scale
|
| Corresponding HDGEC participant Companion
|
Behavioral: FuRST 2.0
Cognitive Pre-testing of new Functional Rating Scale
|
Outcome Measures
Primary Outcome Measures
- Participants' comprehension of the FuRST 2.0 rating scale measured by qualitative analysis [8 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
- The difference between the ratings of the HDGEC participants and the companions measured by the FuRST 2.0 rating scale [8 months]
The secondary outcome measure will be evaluated using the Kolmogorov-Smirnov test
Eligibility Criteria
Criteria
Main criteria for inclusion:
-
HDGEC participant must be a participant in Enroll-HD (NCT No.: NCT01574053)
-
At least 18 years of age
-
Must be fluent in English and had his primary education in English
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Must be willing and able to provide written informed consent
Pre-Manifest HDGECs
Criteria 1-4, and:
-
CAG length greater than or equal to 40
-
Disease Burden Score greater than or equal to 250 (calculated by the equation:
[CAGn-35.5] X age)
-
UHDRS Diagnostic Confidence Level (DCL) < 3
-
At least five Pre-Manifest HDGEC participants should have a companion who is willing to participate in this study and complete the scale independently.
Early-Manifest (Stage 1&2) HDGECs
Criteria 1-4, and:
-
CAG length greater than or equal to 36
-
DCL=4
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UHDRS Total Functional Capacity (TFC) ≥7
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Participants whose companion is willing to participate in this study and complete the scale independently
Main criteria for exclusion:
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Significant cognitive or any other impairment sufficient to interfere with study associated tasks as judged by the study Investigator or the Investigator's designee
-
Currently participating in a clinical trial involving an investigational medicinal product
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rocky Mountain Movement Disorders Center, P.C. | Englewood | Colorado | United States | 80113 |
| 2 | Hereditary Neurology Disease Centre, Inc. | Wichita | Kansas | United States | 67226 |
| 3 | Columbia University | New York | New York | United States | 10032 |
| 4 | CENTRE FOR MOVEMENT DISORDERS (Neuropharm Consulting) | Toronto | Ontario | Canada | M3B 2S7 |
Sponsors and Collaborators
- CHDI Foundation, Inc.
- Dr. Glenn T. Stebbins (Rush University Medical Center )
- The University of Texas Health Science Center, Houston
- Nancy LaPelle
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C-000316