FuRST 2.0 Cognitive Pre-testing - Round 2
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | July 2019 |
| End Date: | February 2020 |
| Contact: | Pua Feigenbaum, PhD |
| Email: | pua.feigenbaum@chdifoundation.org |
| Phone: | 609.945.9582 |
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.
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.
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
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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