Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
A randomised single-blind trial investigating the impact of CPPD disease labels on illness perceptions in adults
Secondary ID [1] 313767 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Calcium pyrophosphate deposition (CPPD) disease 336381 0
Condition category
Condition code
Musculoskeletal 332904 332904 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 333011 333011 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330351 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 340432 0
Response to the embarrassment question on the study questionnaire: "How embarrassed would you feel if you were diagnosed with CPPD/pseudogout?"
Timepoint [1] 340432 0
Within 1 hour after watching the 3-minute video.
Secondary outcome [1] 444042 0
Response to the seriousness question on the study questionnaire: "How serious do you think CPPD/pseudogout is as an illness?"
Timepoint [1] 444042 0
Within 1 hour after watching the 3-minute video.
Secondary outcome [2] 444043 0
Illness Perceptions
Timepoint [2] 444043 0
Within 1 hour after watching the 3-minute video.
Secondary outcome [3] 444044 0
Response to question exploring beliefs on causes of CPPD disease/pseudogout.
Timepoint [3] 444044 0
Within 1 hour after watching the 3-minute video.
Secondary outcome [4] 444045 0
Response to questions exploring beliefs on medications for the treatment of CPPD disease/pseudogout:
Timepoint [4] 444045 0
Within 1 hour after watching the 3-minute video.
Secondary outcome [5] 444046 0
Response to question exploring beliefs on management strategies for CPPD disease/pseudogout.
Timepoint [5] 444046 0
Within 1 hour after watching the 3-minute video.

Eligibility
Key inclusion criteria
- Adults aged 18 years or older
- Able to read and understand English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Health professionals or students enrolled in a health-related degree.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 26836 0
New Zealand
State/province [1] 26836 0

Funding & Sponsors
Funding source category [1] 318229 0
Government body
Name [1] 318229 0
Health Research Council of New Zealand
Country [1] 318229 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 320613 0
None
Name [1] 320613 0
Address [1] 320613 0
Country [1] 320613 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316872 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 316872 0
https://www.auckland.ac.nz/en/research/about-our-research/human-ethics.html
Ethics committee country [1] 316872 0
New Zealand
Date submitted for ethics approval [1] 316872 0
21/01/2025
Approval date [1] 316872 0
Ethics approval number [1] 316872 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139270 0
Prof Nicola Dalbeth
Address 139270 0
School of Medicine, Faculty of Medical & Health Sciences, University of Auckland, Building 507, 28 Park Ave, Grafton, Auckland, 1023
Country 139270 0
New Zealand
Phone 139270 0
+6493737599
Fax 139270 0
Email 139270 0
[email protected]
Contact person for public queries
Name 139271 0
Dr Vicky Tai
Address 139271 0
School of Medicine, Faculty of Medical & Health Sciences, University of Auckland, Building 507, 28 Park Ave, Grafton, Auckland, 1023
Country 139271 0
New Zealand
Phone 139271 0
+6493737599
Fax 139271 0
Email 139271 0
[email protected]
Contact person for scientific queries
Name 139272 0
Prof Nicola Dalbeth
Address 139272 0
School of Medicine, Faculty of Medical & Health Sciences, University of Auckland, Building 507, 28 Park Ave, Grafton, Auckland, 1023
Country 139272 0
New Zealand
Phone 139272 0
+6493737599
Fax 139272 0
Email 139272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.