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NCT03709173 · ClinicalTrials.gov registry record

FuRST 2.0 Cognitive Pre-testing - Round 2

A clinical trial, sponsored by CHDI Foundation.

Completed
Registry status
52
Enrollment target

NCT03709173: Completed study, sponsored by CHDI Foundation.

NCT03709173 is a clinical trial that has completed, run by CHDI Foundation. The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03709173 has completed, sponsored by CHDI Foundation.

COMPLETED
Registry status
52 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • BEHAVIORAL FuRST 2.0

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2019-08-02
Est. Completion 2019-10-25
CHDI Foundation

5 total trials

What the finished NCT03709173 record still lists

NCT03709173 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which FuRST 2.0 is the first listed.

NCT03709173 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03709173 about?

NCT03709173 is a clinical study titled "FuRST 2.0 Cognitive Pre-testing - 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 pat...

What is the current status of trial NCT03709173?

This trial is currently completed. The enrollment target is 52 participants. The study started on 2019-08-02. Estimated completion is 2019-10-25.

What interventions are being tested in trial NCT03709173?

The interventions under investigation include: FuRST 2.0 (BEHAVIORAL).

Who is sponsoring clinical trial NCT03709173?

This trial is sponsored by CHDI Foundation, which has 5 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03709173, the US trial registry maintained by the National Library of Medicine. NCT03709173 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.