Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000767505p
Ethics application status
Submitted, not yet approved
Date submitted
7/06/2024
Date registered
24/06/2024
Date last updated
24/06/2024
Date data sharing statement initially provided
24/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of Healthcare Information About Endometriosis on Social Media on Women’s Medical Decision Making
Scientific title
A randomised online trial evaluating the effect of social media posts about endometriosis on women’s medical decision making.
Secondary ID [1] 312305 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 334050 0
Condition category
Condition code
Public Health 330722 330722 0 0
Health promotion/education
Public Health 330723 330723 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the study is to explore how the content and source credibility of endometriosis-related social media (Instagram) posts influence women’s intention to get a laparoscopy for a diagnosis and treatment of endometriosis.

The study will feature a randomised 2x2x(2) design where participants will be randomly assigned to one of four Instagram posts where post content (personal anecdote vs evidence-based) and account source (high vs low credibility) are varied. A within subjects component will be included to investigate change in intention when informed of the new guidelines stating laparoscopy is no longer required for diagnosis. Participants will first be randomised to view one of four Instagram posts using Qualtrics survey software. They will be blinded to randomised condition. Free stock images will be used to create stimuli that resemble posts on Instagram. A text caption and account user will accompany each image, varying by condition. For the Instagram post content arm, participants will be randomised to view an Instagram post that uses evidence-based information to describe endometriosis, or a personal anecdote of the lived experience of having endometriosis. For the source credibility arm, participants will be either be randomised to view a post from an account typically associated with high source credibility such as the World Health Organisation, or from an account typically associated with low source credibility such as from a layperson or stranger. After viewing the post, all participants will then be presented with the same written hypothetical scenario where a doctor is explaining pain medication and laparoscopy as possible treatment options. After viewing the information presented, participants will complete several outcome measures, including intention to get a laparoscopy, attitudes, perceived norms, self-efficacy, perceived source credibility, and psychosocial outcomes. An attention check item, as well as knowledge measures will also be included to monitor adherence to the intervention. All participants will then view a second hypothetical scenario, where their doctor describes the new treatment guidelines which state that laparoscopy is no longer required for endometriosis diagnosis. Their change in intention will be measured. The study is estimated to take 10-15 minutes.
Intervention code [1] 328778 0
Behaviour
Comparator / control treatment
The control group will view an Instagram post from an account typically associated with high source credibility (World Health Organisation), that features evidence-based information about endometriosis. Participants randomised to this control condition will complete the same outcome measures and are estimated to take a similar time to complete the study.
Control group
Active

Outcomes
Primary outcome [1] 338481 0
Intention to get a laparoscopy for diagnosis and treatment of endometriosis. Adapted from Fisher et al., 2012.
Timepoint [1] 338481 0
Timepoint 1: Administered immediately after participants have read the Instagram post they are randomised to and the hypothetical scenario.
Secondary outcome [1] 436088 0
Attitude towards getting a laparoscopy for the diagnosis of endometriosis (all measured on a 7-point scale, 1=not at all to 7=extremely, items will be averaged to create a composite score). Adapted from Wong et al., 2020.
Timepoint [1] 436088 0
Timepoint 1: After participants have read the Instagram post they are randomised to and the hypothetical scenario.
Secondary outcome [2] 436089 0
Perceived norms about getting a laparoscopy for the diagnosis of endometriosis (all measured on a 7-point scale, 1=Strongly disagree to 7= strongly agree, items will be averaged to create a composite score). Adapted from Wong et al., 2020.
Timepoint [2] 436089 0
Timepoint 1: After participants have read the Instagram post they are randomised to and the hypothetical scenario.
Secondary outcome [3] 436090 0
Perceived self-efficacy about getting a laparoscopy for the diagnosis of endometriosis. Adapted from Schwarzer & Jerusalem, 1995.
Timepoint [3] 436090 0
Timepoint 1: After participants have read the Instagram post they are randomised to and the hypothetical scenario.
Secondary outcome [4] 436091 0
Perceived source credibility, items will be averaged to create a composite score. Adapted from Lee & Sundar, 2013.
Timepoint [4] 436091 0
Timepoint 1: After participants have read the Instagram post they are randomised to and the hypothetical scenario.
Secondary outcome [5] 436092 0
Psychosocial outcomes. These will be assessed as a composite secondary outcome.
Timepoint [5] 436092 0
Timepoint 1: After participants have read the Instagram post they are randomised to and the hypothetical scenario.
Secondary outcome [6] 436093 0
Knowledge Measures. This is a composite secondary outcome comprising of 3 elements: knowledge of the prevalence of endometriosis, knowledge of endometriosis symptoms, and knowledge of endometriosis treatment options. .
Timepoint [6] 436093 0
Timepoint 1: After participants have read the Instagram post they are randomised to and the hypothetical scenario.
Secondary outcome [7] 436094 0
Change in intention
Timepoint [7] 436094 0
Timepoint 2: Administered after participants have been shown the second hypothetical scenario suggesting that laparoscopy is no longer the gold standard for the diagnosis and treatment of endometriosis.

Eligibility
Key inclusion criteria
Women aged 18-45 years living in Australia who have not been diagnosed with endometriosis.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
Participants will be randomly allocated to one of the four Instagram post conditions using Qualtrics survey software. Neither the researchers nor the market research company Dynata will be aware of the condition participants are randomised to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will take place through computerised sequence generation using the Randomizer function included in Qualtrics.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study will first be piloted with a small sample to assess relatability of the posts and scenario, check for issues with randomisation and measures, and inform the final sample size. Statistical analyses will be conducted using Statistical Package for the Social Sciences (SPSS) version 29. Once data collection is complete, data will first be cleaned and checked for missing values, outliers, non-serious responders. We will initially sample an additional 25% of the required sample size to each randomised group (n=250/group, N=1000 total) to ensure an appropriate sample size after this process.

Baseline and demographic characteristics will then be quantified for each arm and overall, with the mean and standard deviations calculated for continuous variables, and frequencies and relative frequencies for categorical variables. To analyse the effect of the post content (personal anecdote vs evidence-based) and account source (high vs low credibility) on participants' intention to get a laparoscopy for the diagnosis and treatment of endometriosis and secondary outcomes, seven 2x2 between-subjects ANOVAs will be conducted. One 2x2 ANCOVA, including pre-exposure intention as a covariate, will be conducted to examine change in intention after viewing guideline advice stating laparoscopy is only necessary if treatment is ineffective. An alpha level of 0.05 will be set for all statistical tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316697 0
Government body
Name [1] 316697 0
National Health and Medical Research Council
Country [1] 316697 0
Australia
Primary sponsor type
University
Name
Sydney School of Public Health, The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318898 0
None
Name [1] 318898 0
Address [1] 318898 0
Country [1] 318898 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315477 0
Research integrity and ethics administration. University of Sydney.
Ethics committee address [1] 315477 0
Ethics committee country [1] 315477 0
Australia
Date submitted for ethics approval [1] 315477 0
01/05/2024
Approval date [1] 315477 0
Ethics approval number [1] 315477 0

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

Contacts
Principal investigator
Name 134814 0
Prof Kirsten McCaffery
Address 134814 0
Room 128B Edward Ford Building (A27) The University of Sydney, Camperdown, NSW, 2006
Country 134814 0
Australia
Phone 134814 0
+61 02 9351 7220
Fax 134814 0
Email 134814 0
[email protected]
Contact person for public queries
Name 134815 0
Kirsten McCaffery
Address 134815 0
Room 128B Edward Ford Building (A27) The University of Sydney, Camperdown, NSW, 2006
Country 134815 0
Australia
Phone 134815 0
+61 02 9351 7220
Fax 134815 0
Email 134815 0
[email protected]
Contact person for scientific queries
Name 134816 0
Kirsten McCaffery
Address 134816 0
Room 128B Edward Ford Building (A27) The University of Sydney, Camperdown, NSW, 2006
Country 134816 0
Australia
Phone 134816 0
+61 02 9351 7220
Fax 134816 0
Email 134816 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected during the trial can be made available in deidentified CSV or excel datasets, along with the data dictionary
When will data be available (start and end dates)?
Data will be made available once the manuscript outlining results from the study has been published for up to 5 years after publication.
Available to whom?
Data will be made available upon request to anyone wishing to access it who provides a methodologically sound proposal to the principal investigator.
Available for what types of analyses?
Replication and meta-analysis
How or where can data be obtained?
Data can be obtained upon direct contact with the chief investigator by emailing [email protected].


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.