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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03709173
Other study ID # C-000918-3
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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