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Trial registered on ANZCTR
Registration number
ACTRN12625000135415p
Ethics application status
Submitted, not yet approved
Date submitted
20/01/2025
Date registered
6/02/2025
Date last updated
6/02/2025
Date data sharing statement initially provided
6/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Calcium Pyrophosphate Deposition (CPPD) Disease Label and Illness Perceptions Study
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Scientific title
A randomised single-blind trial investigating the impact of CPPD disease labels on illness perceptions in adults
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Secondary ID [1]
313767
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Calcium pyrophosphate deposition (CPPD) disease
336381
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Condition category
Condition code
Musculoskeletal
332904
332904
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0
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Other muscular and skeletal disorders
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Inflammatory and Immune System
333011
333011
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants in the exposure group will watch a 3-minute video describing the causes and treatment of a form of arthritis labelled as ‘pseudogout’. The video has been specifically designed by the research team for the purposes of this study.
Participants have the option of watching the video and completing the study questionnaire online over Zoom or in-person at the University of Auckland's Clinical Research Centre.
To ensure that participants have watched the video, they will be asked to name what condition the video was about at the beginning of the study questionnaire.
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Intervention code [1]
330351
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Behaviour
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Comparator / control treatment
Participants in the comparator group will watch a 3-minute video describing the causes and treatment of a form of arthritis labelled as 'CPPD disease'. The information in this video is identical to the video that participants in the intervention/exposure group watched except for the disease label.
Participants have the option of watching the video and completing the study questionnaire online over Zoom or in-person at the University of Auckland's Clinical Research Centre.
To ensure that participants have watched the video, they will be asked to name what condition the video was about at the beginning of the study questionnaire.
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Control group
Active
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Outcomes
Primary outcome [1]
340432
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Response to the embarrassment question on the study questionnaire: "How embarrassed would you feel if you were diagnosed with CPPD/pseudogout?"
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Assessment method [1]
340432
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11-point rating scale: 0 ("not embarrassed at all") to 10 ("extremely embarrassed")
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Timepoint [1]
340432
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Within 1 hour after watching the 3-minute video.
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Secondary outcome [1]
444042
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Response to the seriousness question on the study questionnaire: "How serious do you think CPPD/pseudogout is as an illness?"
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Assessment method [1]
444042
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11-point rating scale: 0 ("not serious at all") to 10 ("extremely serious")
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Timepoint [1]
444042
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Within 1 hour after watching the 3-minute video.
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Secondary outcome [2]
444043
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Illness Perceptions
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Assessment method [2]
444043
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Brief Illness Perception Questionnaire (consists of 8 items including consequences, timeline, personal control, treatment control, identity, concern, understanding, emotional response). Items will be rated on an 11-point scale (0 to 10).
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Timepoint [2]
444043
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Within 1 hour after watching the 3-minute video.
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Secondary outcome [3]
444044
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Response to question exploring beliefs on causes of CPPD disease/pseudogout.
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Assessment method [3]
444044
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Participants will be asked how much they agree the following factors are important in causing the illness: Stress, hereditary factors, diet, aging, alcohol use, environmental pollution, chance or bad luck, a germ or virus, the person's own behaviour. Items will be rated on a 5-point scale from "strongly disagree" to "strongly agree".
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Timepoint [3]
444044
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Within 1 hour after watching the 3-minute video.
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Secondary outcome [4]
444045
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Response to questions exploring beliefs on medications for the treatment of CPPD disease/pseudogout:
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Assessment method [4]
444045
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Participants will be asked the following questions: 1. "How likely is it that you would need long-term medications prescribed for CPPD disease/pseudogout?" - 11-point rating scale: 0 ("wouldn't need it at all") to 10 ("it would be absolutely essential") 2. "How motivated do you think you would be to take long-term medications prescribed for CPPD disease/pseudogout?" - 11-point rating scale: 0 ("not at all motivated") to 10 ("extremely motivated") 3. "How concerned do you think you would be to take long-term medications prescribed for CPPD disease/pseudogout?" - 11-point rating scale: 0 ("not at all concerned") to 10 ("extremely concerned")
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Timepoint [4]
444045
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Within 1 hour after watching the 3-minute video.
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Secondary outcome [5]
444046
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Response to question exploring beliefs on management strategies for CPPD disease/pseudogout.
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Assessment method [5]
444046
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Participants will be asked to rate the effectiveness of the following management strategies for CPPD disease/pseudogout: changing to a healthier diet, using long-term medications, managing stress, regular exercise, stopping or restricting alcohol, using alternative medicine, losing weight. Items will be rated on an 11-point scale from 0 ("wouldn't help at all") to 10 ("very likely to help).
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Timepoint [5]
444046
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Within 1 hour after watching the 3-minute video.
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Eligibility
Key inclusion criteria
- Adults aged 18 years or older
- Able to read and understand English
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Health professionals or students enrolled in a health-related degree.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be created by a statistician using a pseudo-random number generator within Microsoft Excel. Six blocks of variable size with ten to thirty participants each will be created. Within each block, participants who enter the study will be sorted into two groups: the random numbers in the lower half of the block will be allocated to watch the video on pseudogout, and the random numbers in the upper half of the block will be allocated to watch the video on CPPD disease.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
17/03/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26836
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New Zealand
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State/province [1]
26836
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Funding & Sponsors
Funding source category [1]
318229
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Government body
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Name [1]
318229
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Health Research Council of New Zealand
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Address [1]
318229
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Country [1]
318229
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New Zealand
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Primary sponsor type
University
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Name
The University of Auckland
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Address
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Country
New Zealand
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Secondary sponsor category [1]
320613
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None
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Name [1]
320613
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Address [1]
320613
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Country [1]
320613
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
316872
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University of Auckland Human Participants Ethics Committee
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Ethics committee address [1]
316872
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https://www.auckland.ac.nz/en/research/about-our-research/human-ethics.html
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Ethics committee country [1]
316872
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New Zealand
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Date submitted for ethics approval [1]
316872
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21/01/2025
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Approval date [1]
316872
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Ethics approval number [1]
316872
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Summary
Brief summary
Calcium pyrophosphate deposition (CPPD) disease is one of the most common forms of inflammatory arthritis, with prevalence estimates of 4-7% in Europe and the United States. Despite being a common condition, the nomenclature of CPPD disease remains confusing, with many different labels used interchangeably to describe the condition. Whilst ‘CPPD disease’ is the term that has been recommended by the European Alliance of Associations for Rheumatology (EULAR) since 2011, ‘pseudogout’ remains a popular term amongst clinicians, including rheumatologists. A diagnostic label of ‘pseudogout’ may be troublesome, however, as it could be misinterpreted by patients as gout, a condition that is plagued by inaccurate lay views – often considered an embarrassing, self-inflicted condition caused by over-indulgence in food and alcohol. Previous research in gout has demonstrated that disease labels can have a significant impact on illness perceptions, and beliefs about causes and management strategies for an illness. Therefore, the aim of this study is to evaluate how the different labels, ‘pseudogout’ versus ‘CPPD disease’, affect perceptions of this condition and its management. We hypothesise that the pseudogout-labelled illness would be considered a more socially embarrassing condition and attributed to poor diet, due to similarities of this label with gout. By understanding how different labels for CPPD disease affect perceptions of the condition, we can improve how we communicate with patients and the general public about CPPD disease. We expect that findings from the study will be used to inform CPPD disease labels used in clinical practice in the future.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Nicola Dalbeth
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Address
139270
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School of Medicine, Faculty of Medical & Health Sciences, University of Auckland, Building 507, 28 Park Ave, Grafton, Auckland, 1023
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Country
139270
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New Zealand
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Phone
139270
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+6493737599
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Fax
139270
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Email
139270
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[email protected]
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Contact person for public queries
Name
139271
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Dr Vicky Tai
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Address
139271
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School of Medicine, Faculty of Medical & Health Sciences, University of Auckland, Building 507, 28 Park Ave, Grafton, Auckland, 1023
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Country
139271
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New Zealand
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Phone
139271
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+6493737599
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Fax
139271
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Email
139271
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[email protected]
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Contact person for scientific queries
Name
139272
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Prof Nicola Dalbeth
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Address
139272
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School of Medicine, Faculty of Medical & Health Sciences, University of Auckland, Building 507, 28 Park Ave, Grafton, Auckland, 1023
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Country
139272
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New Zealand
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Phone
139272
0
+6493737599
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Fax
139272
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Email
139272
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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