Perspectives on CPPD Outcome Domains

NCT ID: NCT04176003

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-08

Study Completion Date

2020-01-10

Brief Summary

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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.

Detailed Description

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Conditions

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CPPD - Calcium Pyrophosphate Deposition Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Patients with CPPD

Qualitative interview

Intervention Type OTHER

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

Member checking

Intervention Type 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

Qualitative interview

Intervention Type OTHER

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

Member checking

Intervention Type 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.

Stakeholders working on behalf of CPPD patients

Qualitative interview

Intervention Type OTHER

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

Member checking

Intervention Type 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.

Interventions

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Qualitative interview

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

Intervention Type OTHER

Member checking

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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A Abhishek

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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Academic Rheumatology

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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19061

Identifier Type: -

Identifier Source: org_study_id