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| Name | Class |
|---|---|
| Dr. Glenn T. Stebbins (Rush University Medical Center ) | UNKNOWN |
| Dr. Nancy LaPelle | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premanifest HDGEC participants |
| ||
| Early-manifest HDGEC participants |
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| Companions of Premanifest HDGEC |
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| Companions of Early-manifest |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FuRST 2.0 | Behavioral | Round 2 of cognitive pre-testing for a new functional rating scale |
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| Measure | Description | Time Frame |
|---|---|---|
| Participant's comprehension of the FuRST 2.0 rating scale measured by qualitative analysis. | 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 |
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Inclusion Criteria for Premanifest HDGECs:
Inclusion Criteria for Early-manifest HDGECs:
Inclusion Criteria for a Companion of an HDGEC
Exclusion Criteria for an HDGEC/a companion of HDGEC:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Movement Disorders Center, P.C. | Englewood | Colorado | 80113 | United States | ||
| Hereditary Neurological Disease Centre, Inc. |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Wichita |
| Kansas |
| 67226 |
| United States |
| Columbia University | New York | New York | 10032 | United States |
| Centre for Movement Disorders (Neuropharm Consulting) | Toronto | Ontario | M3B 2S7 | Canada |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |