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 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Movement Disorders (Neuropharm Consulting), Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FuRST 2.0

Behavioral

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

CHDI Foundation, Inc.

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Oct 17, 2018
Registry last updated: Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed