Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001149752
Ethics application status
Approved
Date submitted
11/12/2021
Date registered
22/08/2022
Date last updated
22/08/2022
Date data sharing statement initially provided
22/08/2022
Date results provided
22/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Self-management and self-efficacy in endometriosis
Scientific title
Self-management and self-efficacy in endometriosis: a quantitative and qualitative study exploring self-efficacy and self-management strategies of women diagnosed with endometriosis
Secondary ID [1] 305937 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 324531 0
Self-management of endometriosis symptoms 324532 0
Condition category
Condition code
Mental Health 321998 321998 0 0
Other mental health disorders
Reproductive Health and Childbirth 321999 321999 0 0
Other reproductive health and childbirth disorders
Mental Health 322000 322000 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study is split into a quantitative arm and a qualitative arm. The primary aim of the quantitative arm of the study is to investigate factors that are predictive of anxiety and depression amongst those suffering from endometriosis. The anticipated time to complete the online questionnaire is approximately 20 minutes. Participants will only need to complete the one survey. Additionally, the role of self-efficacy will be examined as a potential moderator for symptoms of anxiety and depression. These aims will be investigated using our online questionnaire.
The aim of the qualitative arm of the study will be to determine how women’s self-management of endometriosis has been affected by the COVID-19 pandemic. This aim will be the focus of the semi-structured interview, which is anticipated to take approximately 45-60 minutes. The sem-structured interview will be a once off, delivered via Zoom. Interviews will be completed by a member of the research team, a currently registered provisional psychologist. Participants will be given the opportunity to opt-in following the completion of the quantitative questionnaire. For participants that express interest in the interview, they will be directed to provide their contact details on a secure platform and will then be contacted by a member of the research team.
Intervention code [1] 322329 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329754 0
Self-efficacy. Self-efficacy will be assessed using the PROMIS measures of self-efficacy for managing chronic conditions.
Timepoint [1] 329754 0
This study is not a longitudinal study in nature and does not involve any timepoints. Therefore, all data (such as primary outcome of self-efficacy) will be gathered at baseline.
Secondary outcome [1] 403662 0
The secondary outcome will be psychological distress as measured by symptoms of anxiety and depression. The measure that will be used to assess this outcome will be the DASS-21.
Timepoint [1] 403662 0
This study is not a longitudinal study in nature and does not involve any timepoints. Therefore, all data (such as secondary outcomes of psychological distress) will be gathered at baseline.

Eligibility
Key inclusion criteria
1) Being diagnosed with endometriosis,
2) Aged 18 years or over,
3) Competency of the English language,
4) Access to the internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be used only by the research team. For the quantitative arm of the study, data will be collected via the secure online RedCap portal from Macquarie University, and used only by the research team. Quantitative data will be analysed using STATA. Initial descriptive analyses of demographic and medical characteristics and bivariate associations of these variables with the study outcomes will be undertaken to identify possible covariates using Pearson’s correlation (continuous variables) and chi-square analyses (categorical variables). Inferential statistics analysis will involve linear regression analyses to determine variables associated with self-care and self-efficacy.
For the qualitative arm of the study, data will be collected via semi-structured interviews conducted over Zoom and saved locally. Interviews will be transcribed to enable subsequent analysis. The qualitative analysis is designed to be exploratory and as such does not test hypotheses and has no outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/04/2022
Date of last participant enrolment
Anticipated
Actual
30/06/2022
Date of last data collection
Anticipated
Actual
30/06/2022
Sample size
Target
300
Accrual to date
Final
987
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310276 0
University
Name [1] 310276 0
Macquarie University
Country [1] 310276 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd
Macquarie Park
NSW 2109
Country
Australia
Secondary sponsor category [1] 311383 0
None
Name [1] 311383 0
Address [1] 311383 0
Country [1] 311383 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309947 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 309947 0
Ethics committee country [1] 309947 0
Australia
Date submitted for ethics approval [1] 309947 0
14/10/2021
Approval date [1] 309947 0
12/01/2022
Ethics approval number [1] 309947 0
520211078333729

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

Contacts
Principal investigator
Name 115946 0
Prof Kerry Sherman
Address 115946 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
Macquarie Park 2109
New South Wales
Country 115946 0
Australia
Phone 115946 0
+612 9850 6874
Fax 115946 0
Email 115946 0
kerry.sherman@mq.edu.au
Contact person for public queries
Name 115947 0
Kerry Sherman
Address 115947 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
Macquarie Park 2109
New South Wales
Country 115947 0
Australia
Phone 115947 0
+612 9850 6874
Fax 115947 0
Email 115947 0
kerry.sherman@mq.edu.au
Contact person for scientific queries
Name 115948 0
Kerry Sherman
Address 115948 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
Macquarie Park 2109
New South Wales
Country 115948 0
Australia
Phone 115948 0
+612 9850 6874
Fax 115948 0
Email 115948 0
kerry.sherman@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be made available as data is to be analysed at the group level, rather than individual level. This will ensure privacy confidentiality for participants are maintained. De-identified data will be made available in a publicly available repository (e.g. OpenScience).


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.