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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
24/01/2019
Date data sharing statement initially provided
24/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a comprehensive online resource related to early menopause for consumers.
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.
Secondary ID [1] 297145 0
none
Universal Trial Number (UTN)
U1111-1227-0680
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early menopause 311173 0
Condition category
Condition code
Reproductive Health and Childbirth 309794 309794 0 0
Menstruation and menopause
Public Health 309795 309795 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 313406 0
Other interventions
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.

Control group
Active

Outcomes
Primary outcome [1] 318752 0
Change in health related empowerment from baseline as measured by the validated Health Education Impact Questionnaire
Timepoint [1] 318752 0
Immediate post website view
Primary outcome [2] 318753 0
Website satisfaction measured using a 10 point visual analogue scale
Timepoint [2] 318753 0
Immediate post website view
Secondary outcome [1] 365920 0
Change in quality of life from baseline as measured using the validated Greene Climacteric scale
Timepoint [1] 365920 0
One month post website view
Secondary outcome [2] 365921 0
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)
Timepoint [2] 365921 0
Immediate and one month post website view
Secondary outcome [3] 365922 0
Changes in illness perception from baseline as measured using the validated Brief illness perception questionnaire
Timepoint [3] 365922 0
Immediate and one month post website view

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.
Minimum age
20 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) no diagnosis of early menopause or diagnosis unclear
(ii) unable to read English
(iii) no or limited computer access,

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)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

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

Funding & Sponsors
Funding source category [1] 301700 0
Government body
Name [1] 301700 0
National Health and Medical Research Council
Address [1] 301700 0
16 Marcus Clarke St,
Canberra ACT 2601
Country [1] 301700 0
Australia
Primary sponsor type
University
Name
Monash Centre for Health Research and Implementation, Monash University
Address
43-51 Kanooka Grove
Clayton
Victoria, 3168
Country
Australia
Secondary sponsor category [1] 301426 0
None
Name [1] 301426 0
Address [1] 301426 0
Country [1] 301426 0
Other collaborator category [1] 280499 0
University
Name [1] 280499 0
RMIT
Address [1] 280499 0
Social and Global Studies Centre
School of Global, Urban and Social Studies
RMIT University
124 La Trobe St,
Melbourne
VIC 3000
Country [1] 280499 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302419 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 302419 0
Monash Health Human Research Ethics Committee
Research Support Services
Level 2, I Block
Monash Medical Centre
Clayton Victoria 3168
Ethics committee country [1] 302419 0
Australia
Date submitted for ethics approval [1] 302419 0
25/10/2018
Approval date [1] 302419 0
05/11/2018
Ethics approval number [1] 302419 0
07062A

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.
Trial website
Trial related presentations / publications
Public notes
Email address to contact researchers or register interest in participating in the study:
MCHRI-earlymenopausestudy@monash.edu

Contacts
Principal investigator
Name 90182 0
A/Prof Amanda Vincent
Address 90182 0
Monash Centre for Health Research and Implementation
43-51 Kanooka Grove
Clayton 3168
Victoria
Country 90182 0
Australia
Phone 90182 0
+61 3 85722665
Fax 90182 0
Email 90182 0
amanda.vincent@monash.edu
Contact person for public queries
Name 90183 0
Dr Kim Huynh
Address 90183 0
Monash Centre for Health Research and Implementation
43-51 Kanooka Grove
Clayton 3168
Victoria
Country 90183 0
Australia
Phone 90183 0
+61 (3) 8572 2635
Fax 90183 0
Email 90183 0
MCHRI-earlymenopausestudy@monash.edu
Contact person for scientific queries
Name 90184 0
A/Prof Amanda Vincent
Address 90184 0
Monash Centre for Health Research and Implementation
43-51 Kanooka Grove
Clayton 3168
Victoria
Country 90184 0
Australia
Phone 90184 0
+61 3 85722665
Fax 90184 0
Email 90184 0
amanda.vincent@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.
What supporting documents are/will be available?
No other documents available
Summary results
No Results