FuRST 2.0 Cognitive Pre-testing - Round 2

NCT ID: NCT03709173

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-02

Study Completion Date

2019-10-25

Brief Summary

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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.

Detailed Description

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Conditions

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Huntington Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Premanifest HDGEC participants

FuRST 2.0

Intervention Type BEHAVIORAL

Round 2 of cognitive pre-testing for a new functional rating scale

Early-manifest HDGEC participants

FuRST 2.0

Intervention Type BEHAVIORAL

Round 2 of cognitive pre-testing for a new functional rating scale

Companions of Premanifest HDGEC

FuRST 2.0

Intervention Type BEHAVIORAL

Round 2 of cognitive pre-testing for a new functional rating scale

Companions of Early-manifest

FuRST 2.0

Intervention Type BEHAVIORAL

Round 2 of cognitive pre-testing for a new functional rating scale

Interventions

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FuRST 2.0

Round 2 of cognitive pre-testing for a new functional rating scale

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
* Total Functional Capacity (TFC) ≥11


* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Glenn T. Stebbins (Rush University Medical Center )

UNKNOWN

Sponsor Role collaborator

Dr. Nancy LaPelle

UNKNOWN

Sponsor Role collaborator

CHDI Foundation, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rocky Mountain Movement Disorders Center, P.C.

Englewood, Colorado, United States

Site Status

Hereditary Neurological Disease Centre, Inc.

Wichita, Kansas, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Centre for Movement Disorders (Neuropharm Consulting)

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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C-000918-3

Identifier Type: -

Identifier Source: org_study_id

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