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Osteoarthritis (OA) is a degenerative joint disease which causes joints to become painful and stiff. HOA is the second most common form of OA and is characterized by stiffness, joint pain and inflammation and tenderness in the knuckles or around the waist. This cross-sectional, qualitative interview study aims to explore the experience of erosive HOA as well as explore the content validity of the Michigan Hand Outcomes Questionnaire (MHQ) by conducting semi-structured combined concept elicitation (CE) and cognitive debriefing (CD) telephone interviews and real-time data capture. The conceptual model developed from this data will be used to support the development of GSK3196165, a human monoclonal antibody target for the treatment of HOA. The CE interviews (45 minutes duration) will explore the experience of subjects suffering with HOA and will collect information about symptoms, health related quality of life (HRQoL), treatment experience and the language used by subjects to describe them whereas the CD interviews (45 minutes duration) will assess the content validity of the MHQ. The real-time disease experience of subjects will be captured by the real-time data capture app-based activity over a period of 7 days. Approximately 30 subjects from the United States (US) of which 15 subjects will be erosive HOA and rest 15 will be non-erosive HOA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects participating in the CE and CD interview | Thirty adult subjects from the US with erosive HOA will be asked to participate in CE and CD interviews. |
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| Subjects participating in interview and real time data capture | Ten adult subjects from the US (n=5 with erosive HOA, n=5 with non-erosive HOA) of the thirty subjects who are participating in the CE and CD interviews, will be asked to participate in the real-time data capture app task |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Michigan Hand Outcomes Questionnaire | Other | The MHQ is a self-report measure that assesses the function of the hand(s) and/or wrist(s). The MHQ contains six distinct scales including overall hand function, activities of daily living, pain, work performance, aesthetics and subject satisfaction with hand function. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with hand osteoarthritis participating in CE interviews | CE interviews will be carried out to explore disease experience with respect to symptoms, impacts and treatment/surgical experiences. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Content validity of the Michigan Hand Outcomes Questionnaire through CD interviews | The MHQ is a self-report measure that assesses the function of hand(s) and/or wrist(s). The MHQ contains six distinct scales including overall hand function, activities of daily living, pain, work performance, aesthetics and subject satisfaction with hand function. In a pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance. Subjects will be asked to complete the MHQ questionnaire during CD interview using a 'think-aloud' technique to evaluate the content validity. |
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Inclusion Criteria:
Inclusion Criteria for Erosive Hand OA
Inclusion Criteria for Non-Erosive Hand OA
Inclusion criteria for subjects taking part in real-time data capture:
Exclusion Criteria:
Exclusion Criteria for Erosive Hand OA
Exclusion Criteria for Non-Erosive Hand OA
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Thirty adult US-English speaking subjects with erosive HOA will be included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bollington | Cheshire | SK10 5JB | United Kingdom |
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| Label | URL |
|---|---|
| Results for study 206599 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Real-time data capture app | Other | Real time data capture app is a smart-phone or web-based application which will allow the subjects to provide responses about their experience of HOA in real-time via varying video, audio, photographic and text forms. |
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| 1 day |
| Analysis of hand osteoarthritis experience by using real-time data data capture task | A subgroup of ten of the thirty subjects participating in the CE and CD interviews will be asked to take part in the real-time data capture task over the course of 7 days and during this time a series of questions/tasks will be asked to subjects via the application to explore the experience of the symptoms, HRQoL impacts and treatment of erosive HOA and any day-to-day variability that exists these experiences in 'real time'. | Up to 7 days |
| Preparation of conceptual model | Data obtained from the CE and CD interviews as well as real-time data capture will be used to develop a conceptual model for erosive HOA. Symptom, impact, and treatment concepts which have been identified will be grouped into domains and displayed visually and any identified relationships or trends between domains will also be included in the model. A key will be developed using color coding or bolding/italics to show the source of the concept (example, red if the concept emerged from the interviews only, and green it emerged from the real-time data capture only). In addition, and where relevant the frequency at which a concept was reported across sources will be included in the model. | Up to 7 days |