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Subject Insights to Understand the Hand Osteoarthritis (HOA)

NCT03271203 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2018-10-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Michigan Hand Outcomes Questionnaire

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.

OTHER

Real-time data capture app

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-03
Primary Completion
2017-10-30
Completion
2017-10-30

Countries

  • United Kingdom

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03271203 on ClinicalTrials.gov