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Completed

NCT Number: NCT04176003

Perspectives on CPPD Outcome Domains

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Rheumatology

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qualitative interview

Other

Qualitative interview to explore experiences and perceptions of living with CPPD, and outcome measures to use in future studies

Member checking

Other

Participants will be sent a short report with the researchers' findings from the qualitative interview, and asked to check the accuracy of these and provide brief written feedback.

Primary outcomes

  1. Patient and stakeholders perception of core outcome domains identified from a systematic literature review of clinical studies of patients with CPPD

    Time frame: 1 day

    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.

Secondary outcomes

  1. Experience of living with and perceptions of CPPD, and perceived impact of symptoms on daily life

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

OMERACT Core Domain Set Selection for Calcium Pyrophosphate Deposition (CPPD): Exploring Patient and Stakeholder Perspectives on Outcome Domains

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2019
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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