Perspectives on CPPD Outcome Domains

NCT04176003 | Completed

• 1 other identifier: 19061
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

CPPD - Calcium Pyrophosphate Deposition Disease

Keywords

Calcium Pyrophosphate Deposition Disease; Outcome measures; Qualitative research

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  1 day

Study Arms (3)

Patients with CPPD

Other: Qualitative interview; Other: Member checking

Healthcare professionals working with CPPD patients

Other: Qualitative interview; Other: Member checking

Stakeholders working on behalf of CPPD patients

Other: Qualitative interview; Other: Member checking

Interventions

Qualitative interview OTHER

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

Healthcare professionals working with CPPD patients; Patients with CPPD; Stakeholders working on behalf of CPPD patients

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.

Healthcare professionals working with CPPD patients; Patients with CPPD; Stakeholders working on behalf of CPPD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Academic Rheumatology

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Chondrocalcinosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Study Officials

• A Abhishek

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: November 25, 2019
• Study Start: October 8, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

GB (1)