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Completed

NCT Number: NCT02881931

FuRST 2.0 Cognitive Pre-Testing

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.

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Key information

Conditions

Huntington's 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 Huntington Disease 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

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Who can participate

Healthy volunteers accepted: No

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

Main criteria for inclusion:

  • 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
  • UHDRS Total Functional Capacity (TFC) ≥7
  • Participants whose companion is willing to participate in this study and complete the scale independently

Main criteria for exclusion:

  • 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

Treatment and study plan

FuRST 2.0

Behavioral

Cognitive Pre-testing of new Functional Rating Scale

Primary outcomes

  1. Participants' comprehension of the FuRST 2.0 rating scale measured by qualitative analysis

    Time frame: 8 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.

Secondary outcomes

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

    Time frame: 8 months

    The secondary outcome measure will be evaluated using the Kolmogorov-Smirnov test

Sponsors and collaborators

Lead sponsor

CHDI Foundation, Inc.

Other

Collaborators

  • Dr. Glenn T. Stebbins (Rush University Medical Center )
  • Nancy LaPelle
  • The University of Texas Health Science Center, Houston

Registry information

Official study title

FuRST 2.0: Cognitive Pre-Testing Study for a New Functional Rating Scale for Use in Huntington's Disease

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 29, 2016
Registry last updated
Aug 8, 2017

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.

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