Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001631190
Ethics application status
Approved
Date submitted
13/11/2019
Date registered
25/11/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The prevalence and Impact of Social Media to seek Support and Health Information in Women with Endometriosis.
Scientific title
The prevalence and Impact of Social Media to seek Support and Health Information in Women with Endometriosis.
Secondary ID [1] 299729 0
Nil known
Universal Trial Number (UTN)
U1111-1243-0998
Trial acronym
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 315149 0
Condition category
Condition code
Reproductive Health and Childbirth 313469 313469 0 0
Menstruation and menopause

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to identify if women with a diagnosis of endometriosis are using social media to gain health information, share stories and both provide and receive online support regarding endometriosis.

Patient completed questionnaire.

We will recruit women with a confirmed diagnosis of endometriosis who are patients of the Royal Women’s Hospital. Recruited participants will be provided with a once off electronic questionnaire to complete. The survey will use skip technology and be able to be completed in less than 20 minutes to encourage participation. Basic demographic information will be captured followed by more in-depth questions regarding social media use pertaining to the primary and secondary outcomes. This questionnaire and the subgrouping of social media platforms is modelled after an online global survey of social media use in patients with chronic pain. It has then been modified to patients with endometriosis and to meet our desired study outcomes.

Questionaries will be distributed via a third-party online survey tool (SurveyMonkey) to be completed on the patent’s personal electronic devices. Participants can ask to complete a paper-based survey if they wish. These will be provided to women to be filled out at the time of engagement with the study. Patient Information and Consent Forms (PICF) will be provided at the start of the questionnaire prior to commencing. Information on how to access the online survey tool will be provided to potentially interested parties at the initial interaction. This will be via sms/email link. Participants will undergo treatment and care as usual, with management not affected by their enrolment in this trial. This will be made clear by the clinician at time of offering participation in study. The study will be offered at the end of the consultation to minimise any disruption to the patient-doctor therapeutic relationship.

The majority of patients will be recruited through the Gynaecology 2 Unit at the Royal Women's Hospital which operates on 5-10 cases of endometriosis per week. The targeted clinics include General Gynaecology clinics and post-operative clinics, each of which is held once a week. The number of women seen in these clinics range between 30-40; with at least 10 per clinic likely to meet inclusion criteria. Additional patients will be approached in chronic pain clinic and via phone. The survey only needs to be done as a once off participation event and therefore high rates of survey completion are predicted. With a conservative estimate of 25% of approached women completing the survey, recruitment of 100 participants is expected to be achieved over a six-month period. Data entry will occur concurrently with recruitment, with a further 3 months allocated to analysis of results. Therefore, a generous timeframe for completion of the study would be 12 months.
Intervention code [1] 316039 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321937 0
To assess the prevalence of social media use for seeking health information and support in women with a diagnosis of endometriosis.

This outcome will be assessed by the study specific patient questionnaire. Specifically Participants will be defined as users of social media for the purpose of prevalence calculation if they answer yes to question 13 ‘Have you ever used social media to see health information/support for endometriosis?’
Timepoint [1] 321937 0
At completion of trial after data analysis
Secondary outcome [1] 376747 0
Identification of the most frequently used social media platforms for health information sharing

This outcome will be assessed by the study-specific questionnaire
Timepoint [1] 376747 0
At completion of the trial after data analysis
Secondary outcome [2] 376748 0
Frequency of access of Social Media platforms

This outcome will be assessed by the study-specific questionnaire
Timepoint [2] 376748 0
At completion of the trial after data analysis
Secondary outcome [3] 376749 0
Proportion of experiences that are positive or negative

This outcome will be assessed by the study-specific questionnaire
Timepoint [3] 376749 0
At completion of the trial after data analysis
Secondary outcome [4] 376750 0
Define what makes a positive vs negative health interaction/experience on Social Media

This outcome will be assessed by the study-specific questionnaire
Timepoint [4] 376750 0
At the completion of the trial after data analysis
Secondary outcome [5] 376751 0
Patient or disease factors that influence Social Media use

This outcome will be assessed by the study-specific questionnaire
Timepoint [5] 376751 0
At the completion of the trial after data analysis
Secondary outcome [6] 376752 0
Motives, barriers and expectations of health information sharing/support

This outcome will be assessed by the study-specific questionnaire
Timepoint [6] 376752 0
At the completion of the trial after data analysis
Secondary outcome [7] 376753 0
Gaps in information and services

This outcome will be assessed by the study-specific questionnaire
Timepoint [7] 376753 0
At the completion of the trial after data analysis

Eligibility
Key inclusion criteria
Women greater or equal to 18yrs of age
Confirmed diagnosis of endometriosis via surgical visualisation or histological diagnosis.
- This can be a pre-existing diagnosis prior to engagement with the Royal Women's Hospital
A minimum 6 week timeframe since the confirmed diagnosis was given to the woman
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-consent
Non-English speaking
Women with undiagnosed pelvic pain
Other gynaecological/non-gynaecological causes of pelvic pain without a diagnosis of endometriosis

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
This is an observational study to collect data primarily on prevalence of social media use for health information sharing and support. There is currently no prevalence data reported in literature surrounding the use of social media in either for chronic pain self-management or specifically in women with endometriosis. Previous studies used participant numbers from 69 through to 231; however only recruited people who identified as users of social media/online support groups. As no previous data on this topic has been collected a sample size of 100 participants would be sufficient to provide insight into this area. This is based on sample size calculations using prevalence of 0.5 and precision 0.1 values.

Data analysis methods include descriptive statistical analysis, frequency counts, as well as cross-tabulation to examine any statistical association between variables. Analysis will involve comparing categorical outcomes using Chi squared tests and comparing continuous variables using t-tests. If the data does not have a normal distribution a non-parametric tests such as the Mann Whitney U test will be used. P value of <0.05 will be considered significant. Responses to free text answers will be qualitatively analysed using deductive-inductive semantic thematic analysis. This approach allows for the identification of common themes across the dataset and therefore closely reflects the data and language used by participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15136 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 28430 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 304201 0
Hospital
Name [1] 304201 0
The Royal Women's Hospital
Country [1] 304201 0
Australia
Primary sponsor type
Individual
Name
Dr Kelly van den Haspel
Address
The Royal Women's Hospital
20 Flemington Road
Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 304432 0
Individual
Name [1] 304432 0
Dr Charlotte Reddington
Address [1] 304432 0
The Royal Women's Hospital
20 Flemington Road
Parkville, VIC 3052
Country [1] 304432 0
Australia
Secondary sponsor category [2] 304487 0
Individual
Name [2] 304487 0
Dr Claudia Cheng
Address [2] 304487 0
The Royal Women's Hospital
20 Flemington Road
Parkville, VIC 3052
Country [2] 304487 0
Australia
Secondary sponsor category [3] 304488 0
Individual
Name [3] 304488 0
A/Prof Martin Healey
Address [3] 304488 0
The Royal Women's Hospital
20 Flemington Road
Parkville VIC 3052
Country [3] 304488 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304668 0
Royal Women's Hospital
Ethics committee address [1] 304668 0
Ethics committee country [1] 304668 0
Australia
Date submitted for ethics approval [1] 304668 0
16/10/2019
Approval date [1] 304668 0
18/11/2019
Ethics approval number [1] 304668 0

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

Contacts
Principal investigator
Name 97790 0
Dr Kelly van den Haspel
Address 97790 0
The Royal Women's Hospital
20 Flemington Road
Parkville, VIC 3052
Country 97790 0
Australia
Phone 97790 0
+61 3 8345 2000
Fax 97790 0
Email 97790 0
[email protected]
Contact person for public queries
Name 97791 0
Kelly van den Haspel
Address 97791 0
The Royal Women's Hospital
20 Flemington Road
Parkville, VIC 3052
Country 97791 0
Australia
Phone 97791 0
+61 3 83452000
Fax 97791 0
Email 97791 0
[email protected]
Contact person for scientific queries
Name 97792 0
Kelly van den Haspel
Address 97792 0
The Royal Women's Hospital
20 Flemington Road
Parkville, VIC 3052
Country 97792 0
Australia
Phone 97792 0
+61 3 8345 2000
Fax 97792 0
Email 97792 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
Data and questionnarie answers will be collated during data analysis


What supporting documents are/will be available?




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.