Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000455662
Ethics application status
Approved
Date submitted
18/04/2023
Date registered
2/05/2023
Date last updated
28/04/2024
Date data sharing statement initially provided
2/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of video explanations of illness on healthy adults' perceptions of illness
Scientific title
A randomized study of the impact of framing descriptions of the causes of an illness on healthy adults' perceptions of the illness
Secondary ID [1] 309478 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 329744 0
Condition category
Condition code
Musculoskeletal 326642 326642 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be watching a short video describing the causes of gout using a biological explanation (for example, explanation of genetic risk factors and chronic kidney disease). The video has been created by the researchers and is 2 minutes long. It will be watched as a single viewing. The link to watch the video will be emailed to participants. Participants will watch the video prior to having an interview with a researcher where they will complete a survey about their perceptions of gout. Before doing the survey, the participants will be asked if they have watched the video in its entirety.
Intervention code [1] 325904 0
Behaviour
Comparator / control treatment
The comparator will be a short (2-minute) video describing the causes of gout using a lifestyle explanation (for example, explanation of dietary risk factors). It will be watched as a single viewing. The link to watch the video will be emailed to participants. Participants will watch the video prior to having an interview with a researcher where they will complete a survey about their perceptions of gout. Before doing the survey, the participants will be asked if they have watched the video in its entirety.
Control group
Active

Outcomes
Primary outcome [1] 334507 0
The primary outcome measure will be the response to the treatment control question on the Brief Illness Perceptions Questionnaire (BIPQ): “How likely is it that long-term medications would help gout?”.
Timepoint [1] 334507 0
Participants will complete the questionnaire after watching the video (time 0).
Secondary outcome [1] 420933 0
Responses to the other questions on the Brief Illness Perception Questionnaire.
Timepoint [1] 420933 0
Participants will complete the questionnaire after watching the video (time 0).
Secondary outcome [2] 421301 0
Participant ratings of the likely causes of gout, assessed using a study-specific questionnaire.
Timepoint [2] 421301 0
After viewing the video (time 0).
Secondary outcome [3] 421302 0
Participant ratings of the likely management strategies for gout, assessed using a study-specific questionnaire.
Timepoint [3] 421302 0
After watching the video (time 0).

Eligibility
Key inclusion criteria
Age 18 years and older
Able to complete a questionnaire in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cognitive impairment which would preclude completion of the questionnaire.

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 schedule will be prepared by a statistician working off-site and will not be accessible to the researcher doing the screening for study eligibility/contacting participants/carrying out the surveys.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization schedule will be created by a statistician using a pseudo-random number generator within Microsoft Excel (Microsoft Corp., Redmond, WA, US). 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 biological explanation video, and the random numbers in the upper half of the block to watch the lifestyle explanation video.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size of 200 participants is based on a previous study of diseases labelled ‘urate crystal arthritis’ or ‘gout’. This sample size allowed the detection of at least a 2-point difference for each Brief Illness Perception Questionnaire (BIPQ) item with a 90% power and an alpha of 0.05. P-values will be adjusted for multiple comparisons using the Bonferroni calculation. The primary outcome measure will be the response to the treatment control question on the BIPQ: “How likely is it that long-term medications would help gout?”.
Demographic differences between the two groups will be explored with independent sample t-tests and chi-square tests. Differences between the groups in ratings of illness perceptions, causes, and management strategies will be tested with independent sample t-tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/06/2023
Actual
30/06/2023
Date of last participant enrolment
Anticipated
18/10/2023
Actual
11/04/2024
Date of last data collection
Anticipated
31/10/2023
Actual
11/04/2024
Sample size
Target
200
Accrual to date
Final
202
Recruitment outside Australia
Country [1] 25401 0
New Zealand
State/province [1] 25401 0

Funding & Sponsors
Funding source category [1] 313675 0
University
Name [1] 313675 0
University of Auckland
Country [1] 313675 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland,
25 Park Avenue,
Grafton,
Auckland 1023,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 315476 0
None
Name [1] 315476 0
Address [1] 315476 0
Country [1] 315476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312840 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 312840 0
Ethics committee country [1] 312840 0
New Zealand
Date submitted for ethics approval [1] 312840 0
12/04/2023
Approval date [1] 312840 0
17/05/2023
Ethics approval number [1] 312840 0
UAHPEC25912

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126102 0
Dr Rachel Murdoch
Address 126102 0
Faculty of Medical and Health Sciences,
University of Auckland,
25 Park Avenue,
Grafton,
Auckland 1023,
New Zealand
Country 126102 0
New Zealand
Phone 126102 0
+64 9 373 7599
Fax 126102 0
Email 126102 0
[email protected]
Contact person for public queries
Name 126103 0
Rachel Murdoch
Address 126103 0
Faculty of Medical and Health Sciences,
University of Auckland,
25 Park Avenue,
Grafton,
Auckland 1023,
New Zealand
Country 126103 0
New Zealand
Phone 126103 0
+64 9 373 7599
Fax 126103 0
Email 126103 0
[email protected]
Contact person for scientific queries
Name 126104 0
Rachel Murdoch
Address 126104 0
Faculty of Medical and Health Sciences,
University of Auckland,
25 Park Avenue,
Grafton,
Auckland 1023,
New Zealand
Country 126104 0
New Zealand
Phone 126104 0
+64 9 373 7599
Fax 126104 0
Email 126104 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.