CPPD - Calcium Pyrophosphate Deposition DiseaseNCT04176003
Perspectives on CPPD Outcome Domains
An observational study of CPPD - Calcium Pyrophosphate Deposition Disease, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CPPD - Calcium Pyrophosphate Deposition Disease
- What is being tested?
- Qualitative interview and Member checking
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Oct 2019to 10 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with CPPD, healthcare practitioners who work with patients with CPPD, and stakeholders who work on behalf of those with CPPD
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Rheumatology
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: OMERACT Core Domain Set Selection for Calcium Pyrophosphate Deposition (CPPD): Exploring Patient and Stakeholder Perspectives on 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.
Read more
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.
- Being tested
- Qualitative interview, Member checking
- Keywords
- Calcium Pyrophosphate Deposition Disease, Outcome measures, Qualitative research
- Medical subject headings
- Chondrocalcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interviewOther
Qualitative interview to explore experiences and perceptions of living with CPPD, and outcome measures to use in future studies
Member checkingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with CPPD | Not described Receives: Other: Qualitative interview; Other: Member checking | |
| Healthcare professionals working with CPPD patients | Not described Receives: Other: Qualitative interview; Other: Member checking | |
| Stakeholders working on behalf of CPPD patients | Not described Receives: Other: Qualitative interview; Other: Member checking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
Experience of living with and perceptions of CPPD, and perceived impact of symptoms on daily life
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start8 Oct 2019
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CPPD - Calcium Pyrophosphate Deposition DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A Abhishek, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176003
- Sponsor's protocol ID
- 19061
- Status last verified
- Nov 2020
- First submitted
- 17 Oct 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OMERACT Core Domain Set Selection for Calcium Pyrophosphate Deposition (CPPD): Exploring Patient and Stakeholder Perspectives on Outcome Domains
- ClinicalTrials.gov ID
- NCT04176003
- Acronym / sponsor ID
- 19061
- Keywords
- Calcium Pyrophosphate Deposition Disease, Outcome measures, Qualitative research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CPPD, healthcare practitioners who work with patients with CPPD, and stakeholders who work on behalf of those with CPPD
Key inclusion criteria (8 listed)
- 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
- A healthcare professional (nurse, GP or hospital doctor) who cares or has cared for patients with CPPD
- Government organisations, non-government organisations, pharmaceutical representatives and health advocacy groups
Key exclusion criteria (7 listed)
- Dementia
- Terminal illness
- Unable to give informed consent
- Stroke with receptive or expressive dysphasia
- Severe enduring mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative interviewQualitative interview to explore experiences and perceptions of living with CPPD, and outcome measures to use in future studies | Other | Healthcare professionals working with CPPD patients, Patients with CPPD, Stakeholders working on behalf of CPPD patients |
| Member checkingParticipants 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. | Other | Healthcare professionals working with CPPD patients, Patients with CPPD, Stakeholders working on behalf of CPPD patients |
Primary outcome
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.
1 secondary outcome
Experience of living with and perceptions of CPPD, and perceived impact of symptoms on daily life
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Abhishek principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CPPD - Calcium Pyrophosphate Deposition Disease, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.