FuRST 2.0 Cognitive Pre-Testing

NCT02881931 | Completed

• 1 other identifier: C-000316
• Study Type: observational
• Target: 75
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Huntington's Disease

Keywords

Huntington's disease; functional rating scale; cognitive pre-testing; patient reported outcome (PRO); HDGEC participant at Pre-Manifest stage; HDGEC participant at Early-Manifest stage; Corresponding HDGEC participant companion

Outcome Measures

Primary Outcomes (1)

• Participants' 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.

  8 months

Secondary Outcomes (1)

• The difference between the ratings of the HDGEC participants and the companions measured by the FuRST 2.0 rating scale

  8 months

Study Arms (3)

Pre-Manifest HDGEC Participant

Behavioral: FuRST 2.0

Early-Manifest HDGEC Participant

Behavioral: FuRST 2.0

Corresponding HDGEC participant Companion

Behavioral: FuRST 2.0

Interventions

FuRST 2.0 BEHAVIORAL

Cognitive Pre-testing of new Functional Rating Scale

Corresponding HDGEC participant Companion; Early-Manifest HDGEC Participant; Pre-Manifest HDGEC Participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants: Individuals of either gender, equal to or greater than 18 years of age. HDGEC Pre-Manifest and Early-Manifest participants (see inclusion criteria) will be recruited from English speaking Enroll-HD sites. Companions: Available companions for HDGEC Pre-Manifest participants will be encouraged to participate (at least five Pre-Manifest's companions are required). Companions will be identified for HDGEC Early-Manifest participants and asked to participate. Companion's participation for HDGEC Early-Manifest participant is mandatory as specified in the inclusion criteria.

You may qualify if:

• HDGEC participant must be a participant in Enroll-HD (NCT No.: NCT01574053)
• At least 18 years of age
• Must be fluent in English and had his primary education in English
• Must be willing and able to provide written informed consent
• Pre-Manifest HDGECs
• Criteria 1-4, and:
• CAG length greater than or equal to 40
• Disease Burden Score greater than or equal to 250 (calculated by the equation:
• \[CAGn-35.5\] X age)
• UHDRS Diagnostic Confidence Level (DCL) \< 3
• 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:
• CAG length greater than or equal to 36
• DCL=4

You may not qualify if:

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

Sponsors & Collaborators

• CHDI Foundation, Inc.: lead
• Dr. Glenn T. Stebbins (Rush University Medical Center ): collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Nancy LaPelle: collaborator

Study Sites (4)

Rocky Mountain Movement Disorders Center, P.C.

Englewood, Colorado, 80113, United States

Location

Hereditary Neurology Disease Centre, Inc.

Wichita, Kansas, 67226, United States

Location

Columbia University

New York, New York, 10032, United States

Location

CENTRE FOR MOVEMENT DISORDERS (Neuropharm Consulting)

Toronto, Ontario, M3B 2S7, Canada

Location

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 29, 2016
• Study Start: February 28, 2017
• Primary Completion: July 28, 2017
• Study Completion: July 28, 2017
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

CA (1); US (3)