FuRST 2.0 Cognitive Pre-testing - Round 2

Huntington Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709173
• Other study ID #: C-000918-3
• Status: Completed
• Start date: August 2, 2019
• Est. completion date: October 25, 2019

Study information

• Verified date: October 2019
• Source: CHDI Foundation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 25, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Premanifest HDGECs:

• 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

Inclusion Criteria for Early-manifest HDGECs:

• 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

• Total Functional Capacity (TFC) =11

Inclusion Criteria for a Companion of an HDGEC

• At least 18 years of age

• Fluent in English and had his/her primary education in English

• 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 PI or site PI's designee

• Willing and able to provide written informed consent

Exclusion Criteria for an HDGEC/a companion of HDGEC:

• 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

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Behavioral:
• FuRST 2.0
Round 2 of cognitive pre-testing for a new functional rating scale

Locations

Country	Name	City	State
Canada	Centre for Movement Disorders (Neuropharm Consulting)	Toronto	Ontario
United States	Rocky Mountain Movement Disorders Center, P.C.	Englewood	Colorado
United States	Columbia University	New York	New York
United States	Hereditary Neurological Disease Centre, Inc.	Wichita	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
CHDI Foundation, Inc.	Dr. Glenn T. Stebbins (Rush University Medical Center ), Dr. Nancy LaPelle

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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