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
1 other identifier
observational
52
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2019
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2018
CompletedFirst Posted
Study publicly available on registry
October 17, 2018
CompletedStudy Start
First participant enrolled
August 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2019
CompletedOctober 29, 2019
October 1, 2019
3 months
September 25, 2018
October 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Participant's comprehension of the FuRST 2.0 rating scale measured by qualitative analysis.
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.
7 months
Study Arms (4)
Premanifest HDGEC participants
Early-manifest HDGEC participants
Companions of Premanifest HDGEC
Companions of Early-manifest
Interventions
Round 2 of cognitive pre-testing for a new functional rating scale
Eligibility Criteria
An HDGEC: Premanifest and early-manifest HDGEC who is also a participant in Enroll-HD and meets the protocol selection criteria for the HDGEC. HDGEC participants will be recruited from English speaking Enroll-HD sites. A Companion: A person who, in his/her opinion, has sufficient interaction and knowledge of the HDGEC participant's capabilities and daily activities, is acceptable to the HDGEC participant and the site principal investigator (site PI) or site PI's designee and meets the protocol selection criteria for the companion. The companion's participation is optional in this study.
You may qualify if:
- Identified as an active participant in Enroll-HD (participants who have completed their last onsite Enroll-HD visit within approximately 15 months)
- At least 18 years of age
- Fluent in English and had his/her primary education in English
- Able and willing to provide critical feedback (per site PI or site PI's designee discretion)
- Willing and able to provide written informed consent
- Cytosine, Adenine, Guanine (CAG) length ≥ 40
- Disease burden score (DBS) ≥ 250
- Diagnostic confidence level (DCL) ≤ 3
- Identified as an active participant in Enroll-HD (participants who have completed their last onsite Enroll-HD visit within approximately 15 months)
- At least 18 years of age
- Fluent in English and had his/her primary education in English
- Able and willing to provide critical feedback (per site PI or site PI's designee discretion)
- Willing and able to provide written informed consent
- CAG length ≥ 36
- DCL= 4
- +6 more criteria
You may not qualify if:
- Significant cognitive or any other impairment sufficient to interfere with study associated tasks as judged by the site PI or the site PI's designee
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHDI Foundation, Inc.lead
- Dr. Glenn T. Stebbins (Rush University Medical Center )collaborator
- Dr. Nancy LaPellecollaborator
Study Sites (4)
Rocky Mountain Movement Disorders Center, P.C.
Englewood, Colorado, 80113, United States
Hereditary Neurological Disease Centre, Inc.
Wichita, Kansas, 67226, United States
Columbia University
New York, New York, 10032, United States
Centre for Movement Disorders (Neuropharm Consulting)
Toronto, Ontario, M3B 2S7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2018
First Posted
October 17, 2018
Study Start
August 2, 2019
Primary Completion
October 25, 2019
Study Completion
October 25, 2019
Last Updated
October 29, 2019
Record last verified: 2019-10