FuRST 2.0 Cognitive Pre-Testing

NCT ID: NCT02881931

Last Updated: 2017-08-08

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

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-28

Study Completion Date

2017-07-28

Brief Summary

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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.

Detailed Description

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Conditions

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Huntington's Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-Manifest HDGEC Participant

FuRST 2.0

Intervention Type BEHAVIORAL

Cognitive Pre-testing of new Functional Rating Scale

Early-Manifest HDGEC Participant

FuRST 2.0

Intervention Type BEHAVIORAL

Cognitive Pre-testing of new Functional Rating Scale

Corresponding HDGEC participant Companion

FuRST 2.0

Intervention Type BEHAVIORAL

Cognitive Pre-testing of new Functional Rating Scale

Interventions

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FuRST 2.0

Cognitive Pre-testing of new Functional Rating Scale

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. HDGEC participant must be a participant in Enroll-HD (NCT No.: NCT01574053)
2. At least 18 years of age
3. Must be fluent in English and had his primary education in English
4. Must be willing and able to provide written informed consent

Pre-Manifest HDGECs

Criteria 1-4, and:

1. CAG length greater than or equal to 40
2. Disease Burden Score greater than or equal to 250 (calculated by the equation:

\[CAGn-35.5\] X age)
3. UHDRS Diagnostic Confidence Level (DCL) \< 3
4. 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:

1. CAG length greater than or equal to 36
2. DCL=4
3. UHDRS Total Functional Capacity (TFC) ≥7
4. Participants whose companion is willing to participate in this study and complete the scale independently

Main criteria for exclusion:

1. Significant cognitive or any other impairment sufficient to interfere with study associated tasks as judged by the study Investigator or the Investigator's designee
2. Currently participating in a clinical trial involving an investigational medicinal product
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

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

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 Neurology 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-000316

Identifier Type: -

Identifier Source: org_study_id

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