跳至主要内容
临床试验/NCT04176003
NCT04176003已完成不适用

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

University of Nottingham1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Patient and stakeholders perception of core outcome domains identified from a systematic literature review of clinical studies of patients with CPPD

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Experience of living with and perceptions of CPPD, and perceived impact of symptoms on daily life(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验