CPPD - Calcium Pyrophosphate Deposition Disease Clinical Trial
Official title:
OMERACT Core Domain Set Selection for Calcium Pyrophosphate Deposition (CPPD): Exploring Patient and Stakeholder Perspectives on Outcome Domains
| NCT number | NCT04176003 |
| Other study ID # | 19061 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 8, 2019 |
| Est. completion date | January 10, 2020 |
| Verified date | November 2020 |
| Source | University of Nottingham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to obtain patient and stakeholder perspectives on what outcome measures should be included in future trials on CPPD (Calcium PyroPhosphate Deposition), a common form of inflammatory arthritis. This will form part of a wider OMERACT (Outcome Measures in Rheumatology) study, involving multiple international sites, to determine a core domain set (an agreed set of outcome measures) for this disease. In the UK, up to 10 patients with CPPD and their caregivers, healthcare professionals who care for patients with CPPD, and other stakeholders, which may include government organisations, non-government organisations, pharmaceutical representatives and health advocacy groups, will be invited to participate in a single, semi-structured interview. Interviews will be face-to-face or telephone, last up to one hour and digitally audio-recorded. For patients and their caregivers, interviews will explore their lived experience of CPPD, its impact on their daily lives, and the perceived relevance of outcome measures used in previous studies. For healthcare professionals and other stakeholders, interviews will explore their experience dealing with patients with CPPD, how they perceive CPPD impacts patient lives, and the perceived relevance of the outcome measures used in previous studies. Following analysis of the data, participants will be sent a short report with the researchers' findings, and asked to check the accuracy of these and provide brief written feedback. Interviews will also take place with patients, caregivers, healthcare practitioners and stakeholders at the other international sites where ethics committee approval will be sought locally. It is anticipated that around 30 participants will be recruited across all sites. Analysis of all interviews will be primarily conducted and managed at the UK site.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | January 10, 2020 |
| Est. primary completion date | January 10, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: Patients: - People with a diagnosis of CPPD of any form and/or their caregiver (includes acute CPP crystal arthritis (pseudogout), chronic CPP crystal arthritis, crowned dens syndrome, and osteoarthritis with CPPD) - Ability to give informed consent - Age over 18 years Healthcare professionals: - A healthcare professional (nurse, GP or hospital doctor) who cares or has cared for patients with CPPD Other stakeholders: - Government organisations, non-government organisations, pharmaceutical representatives and health advocacy groups Exclusion Criteria: - Dementia - Terminal illness - Unable to give informed consent - Stroke with receptive or expressive dysphasia - Severe enduring mental illness - Autoimmune rheumatic disease such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout - Total joint replacement in the previous 3 months |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Academic Rheumatology | Nottingham | Nottinghamshire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Nottingham |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patient and stakeholders perception of core outcome domains identified from a systematic literature review of clinical studies of patients with CPPD | This is a qualitative interview study, the primary aim is to collect patient and stakeholder perspectives on existing outcome measures of CPPD. Currently there are no recommended core outcome measure sets for CPPD and this work is being undertaken within the framework of OMERACT. Thematic analysis will be undertaken of interview transcripts and therefore there is no defined outcome measure. | 1 day | |
| Secondary | Experience of living with and perceptions of CPPD, and perceived impact of symptoms on daily life | This is a qualitative interview study, the secondary aim is to collect patients' experiences of living with CPPD as well as their and stakeholders perception of the impact of CPPD symptoms, to identify any further outcome measures that could be used in studies of CPPD. Currently there are no recommended core outcome measure sets for CPPD and this work is being undertaken within the framework of OMERACT. Thematic analysis will be undertaken of interview transcripts and therefore there is no defined outcome measure. There is no specific recall period for which experiences will be assessed as this will be dependent on each individual's disease duration. | 1 day |