Clinical trial NCT04176003: Perspectives on CPPD Outcome Domains
Official title: OMERACT Core Domain Set Selection for Calcium Pyrophosphate Deposition (CPPD): Exploring Patient and Stakeholder Perspectives on Outcome Domains
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CPPD - Calcium Pyrophosphate Deposition Disease
Keywords: Calcium Pyrophosphate Deposition Disease
Outcome measures
Qualitative research
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CPPD, healthcare practitioners who work with patients with CPPD, and stakeholders who work on behalf of those with CPPD

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient and stakeholders perception of core outcome domains identified from a systematic literature review of clinical studies of patients with CPPD
timeFrame: 1 day
Secondary outcomes:
measure: Experience of living with and perceptions of CPPD, and perceived impact of symptoms on daily life
timeFrame: 1 day
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Academic Rheumatology
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: A Abhishek
role: PRINCIPAL_INVESTIGATOR
References: