FuRST 2.0 Cognitive Pre-testing - Round 2

October 28, 2019 updated by: CHDI Foundation, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3B 2S7
        • Centre for Movement Disorders (Neuropharm Consulting)
  • United States
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Rocky Mountain Movement Disorders Center, P.C.
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Hereditary Neurological Disease Centre, Inc.
    • New York
      • New York, New York, United States, 10032
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

An HDGEC: Premanifest and early-manifest HDGEC who is also a participant in Enroll-HD and meets the protocol selection criteria for the HDGEC. HDGEC participants will be recruited from English speaking Enroll-HD sites.

A Companion: A person who, 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 principal investigator (site PI) or site PI's designee and meets the protocol selection criteria for the companion. The companion's participation is optional in this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Premanifest HDGEC participants
Behavioral: FuRST 2.0
Round 2 of cognitive pre-testing for a new functional rating scale
Early-manifest HDGEC participants
Behavioral: FuRST 2.0
Round 2 of cognitive pre-testing for a new functional rating scale
Companions of Premanifest HDGEC
Behavioral: FuRST 2.0
Round 2 of cognitive pre-testing for a new functional rating scale
Companions of Early-manifest
Behavioral: FuRST 2.0
Round 2 of cognitive pre-testing for a new functional rating scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant's comprehension of the FuRST 2.0 rating scale measured by qualitative analysis.
Time Frame: 7 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHDI Foundation, Inc.

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2019

Primary Completion (Actual)

October 25, 2019

Study Completion (Actual)

October 25, 2019

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (Actual)

October 17, 2018

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-000918-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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