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Trial registered on ANZCTR
Registration number
ACTRN12619000107123
Ethics application status
Approved
Date submitted
21/01/2019
Date registered
24/01/2019
Date last updated
18/11/2021
Date data sharing statement initially provided
24/01/2019
Date results information initially provided
18/11/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluation of a comprehensive online resource related to early menopause for consumers.
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Scientific title
Early Menopause: Implementation Research using the Experiences and Perspectives of Women and Health Professionals to Translate Evidence into Practice. Randomised controlled trial to evaluate a co-designed Early menopause online resource.
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Secondary ID [1]
297145
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none
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Universal Trial Number (UTN)
U1111-1227-0680
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Early menopause
311173
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Condition category
Condition code
Reproductive Health and Childbirth
309794
309794
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0
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Menstruation and menopause
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Public Health
309795
309795
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Two-arm parallel randomised controlled trial.
Participants will be randomized to view either the newly developed Healthtalk early menopause website (intervention) or a currently available general menopause website (control) as per the procedure below. Healthtalk Australia websites, produced and hosted by Healthdirect Australia provide accurate information about a range of health conditions. The newly developed website relates specifically to early menopause (including symptoms, infertility, long term consequences and management options) and provides a variety of resources including informative web pages, downloadable factsheets, links to other resources (videos, webpage, factsheets) video and audio clips of women's experiences, and where to seek help.
Both the intervention and control will be delivered via the internet to participants.
The online study link will take participants to a screening webpage, and if eligible, participants will be provided with an Informed Participant Information and Consent form. Consent for this study will be carried out electronically, and will allow for the capture of an electronic signature. Once the Consent is submitted online, participants will be redirected to the Baseline Evaluation survey. After the Baseline Evaluation survey is completed the study team will receive a notification, and participants will be randomised to either the intervention website or control website and emailed a link to the designated website to view the website and then complete the Immediate Post Intervention Survey. Women are free to access any or all parts of the website and have access to the website for the duration of the study until the final 1 month post intervention survey is completed. The final survey - 1 Month Post Intervention Survey will be automatically sent to participants to complete 30 days after the Immediate Post Intervention Survey has been submitted. Researchers are able to remotely monitor whether the surveys have been completed and reminder emails will be sent automatically to complete the surveys if they have not been submitted within 14 days of delivery.
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Intervention code [1]
313406
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Other interventions
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Comparator / control treatment
Currently available general menopause website which is not specific to early menopause. This website provides information related to menopausal symptoms, management and long term sequele of menopause in the form of webpages and downloadable factsheets. Links to other resources are also provided.
Both the intervention and control will be delivered via the internet to participants.
Participants randomised to the control website are emailed a link to the website to view the website and then complete the Immediate Post Intervention Survey. Women are free to access any or all parts of the website and have access to the website for duration of the study until the final 1 month post intervention survey is completed (as this website is available to the general community currently, women may potentially access the website outside of the study). The final survey - 1 Month Post Intervention Survey will be automatically sent to participants to complete 30 days after the Immediate Post Intervention Survey has been submitted. Researchers are able to remotely monitor whether the surveys have been completed and reminder emails will be sent automatically to complete the surveys if they have not been submitted within 14 days of delivery.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in health related empowerment from baseline as measured by the validated Health Education Impact Questionnaire
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Assessment method [1]
318752
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Timepoint [1]
318752
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Immediate post website view
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Primary outcome [2]
318753
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Website satisfaction measured using a 10 point visual analogue scale
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Assessment method [2]
318753
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Timepoint [2]
318753
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Immediate post website view
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Secondary outcome [1]
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Change in quality of life from baseline as measured using the validated Greene Climacteric scale
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Assessment method [1]
365920
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Timepoint [1]
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One month post website view
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Secondary outcome [2]
365921
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Changes in menopause knowledge from baseline using a previously published questionnaire (Trudeau KJ, Ainscough JL, Trant M, Starker J, Cousineau TM. Identifying the educational needs of menopausal women: a feasibility study. Womens Health Issues. 2011; 21: 145-52)
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Assessment method [2]
365921
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Timepoint [2]
365921
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Immediate and one month post website view
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Secondary outcome [3]
365922
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Changes in illness perception from baseline as measured using the validated Brief illness perception questionnaire
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Assessment method [3]
365922
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Timepoint [3]
365922
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Immediate and one month post website view
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Eligibility
Key inclusion criteria
(i) women with diagnosis of early menopause (menopause occurring before age 45 years) aged 20 years or over
(ii) computer access
(iii) use of the internet at least once per week
(iv) personal email address.
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Minimum age
20
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(i) no diagnosis of early menopause or diagnosis unclear
(ii) unable to read English
(iii) no or limited computer access,
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size calculation was based on parameters obtained from a similar published study. Based on all individual components of the Health Education Impact Questionnaire (except for emotional wellbeing for which there was no clinically meaningful effect size seen), we based our final sample size based on the minimum effect size to estimate. To estimate a mean difference of 0.11 (standard deviation of 0.54), a sample size of 379 per arm (total=758) would be required for a power of 80% and level of significance set at 5%. Assuming that 10% will be lost to follow-up, a total of 422 patients per arm (844 total) will be required for the study. Sample size calculation was performed in PS Power and Sample Size software V13.0.
The Analysis of Covariance (ANCOVA) model will be used to compare changes in outcome measures at follow-up, after adjusting for baseline values. In addition, we may adjust for variables such as educational level and country of birth, if necessary. Appropriate transformation of the data (e.g. natural logarithmic) will be undertaken in the event of skewness of distribution. Analysis will be based on intention to treat principle and level of significance set at 5%. Data analysis will be performed in Stata V13.0.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
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Other reasons
A unanticipated software upgrade resulted in an irretrievable failure of the automated online randomisation process.
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Date of first participant enrolment
Anticipated
24/01/2019
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Actual
24/01/2019
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Date of last participant enrolment
Anticipated
29/04/2019
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Actual
29/04/2019
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Date of last data collection
Anticipated
31/05/2019
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Actual
31/05/2019
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Sample size
Target
844
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Accrual to date
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Final
257
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
301700
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Government body
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Name [1]
301700
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National Health and Medical Research Council
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Address [1]
301700
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16 Marcus Clarke St,
Canberra ACT 2601
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Country [1]
301700
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Australia
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Primary sponsor type
University
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Name
Monash Centre for Health Research and Implementation, Monash University
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Address
43-51 Kanooka Grove
Clayton
Victoria, 3168
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Country
Australia
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Secondary sponsor category [1]
301426
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None
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Name [1]
301426
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Address [1]
301426
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Country [1]
301426
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Other collaborator category [1]
280499
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University
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Name [1]
280499
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RMIT
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Address [1]
280499
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Social and Global Studies Centre
School of Global, Urban and Social Studies
RMIT University
124 La Trobe St,
Melbourne
VIC 3000
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Country [1]
280499
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302419
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Monash Health Human Research Ethics Committee
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Ethics committee address [1]
302419
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Monash Health Human Research Ethics Committee
Research Support Services
Level 2, I Block
Monash Medical Centre
Clayton Victoria 3168
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Ethics committee country [1]
302419
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Australia
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Date submitted for ethics approval [1]
302419
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25/10/2018
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Approval date [1]
302419
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05/11/2018
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Ethics approval number [1]
302419
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07062A
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Summary
Brief summary
Study purpose
The aim of this project is to find out the usefulness and helpfulness of the newly developed co-designed Early Menopause website compared to what is currently available.
Who is it for?
Women aged 20 years or over with a diagnosis of early menopause (menopause occurring before age 45 years).
What does it involve?
We will explore and compare the views of women with early menopause (EM) on their experience, satisfaction and knowledge after looking at the EM website or another menopause website currently available. To try to make sure the groups are the same, each participant will be put into a group by chance (random) to either review the EM website or a currently available menopause website and complete 3 surveys.
After you agree to participate and complete a baseline survey, you will be sent a link to one of the 2 websites randomly chosen for you. After viewing the website, you will be asked to complete an online survey immediately after you look at the website. You will then be sent a link one month later to complete a further follow-up survey. Each survey will take approximately 20 minutes to complete. All women regardless of group will be able to freely access the EM website once the evaluation process is completed and the website is launched.
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Trial website
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Trial related presentations / publications
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Public notes
Study recruitment has ceased.
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Contacts
Principal investigator
Name
90182
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A/Prof Amanda Vincent
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Address
90182
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Monash Centre for Health Research and Implementation
43-51 Kanooka Grove
Clayton 3168
Victoria
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Country
90182
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Australia
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Phone
90182
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+61 3 85722665
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Fax
90182
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Email
90182
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[email protected]
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Contact person for public queries
Name
90183
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A/Prof Amanda Vincent
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Address
90183
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Monash Centre for Health Research and Implementation
43-51 Kanooka Grove
Clayton 3168
Victoria
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Country
90183
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Australia
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Phone
90183
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+61 3 85722665
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Fax
90183
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Email
90183
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[email protected]
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Contact person for scientific queries
Name
90184
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A/Prof Amanda Vincent
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Address
90184
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Monash Centre for Health Research and Implementation
43-51 Kanooka Grove
Clayton 3168
Victoria
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Country
90184
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Australia
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Phone
90184
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+61 3 85722665
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Fax
90184
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Email
90184
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Access to individual de-identified data may be made available on a case by case basis after communication with the investigators for purposes of meta-analyses following publication.
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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
Source
Title
Year of Publication
DOI
Embase
Positive impact of a co-designed digital resource for women with early menopause.
2022
https://dx.doi.org/10.1097/GME.0000000000001972
N.B. These documents automatically identified may not have been verified by the study sponsor.
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