Virtual perI-/Menopause Registry of AusTrALia
VITAL
1 other identifier
observational
10,000
1 country
1
Brief Summary
13 million (50.7%) Australians are born with ovaries, 14% (\~3 million) are currently aged 40-59 yrs, \& all such who live to midlife will experience menopause, defined as \>12 months without a period. Peri-menopause (peri), typically occurs 5 yrs before menopause as hormone levels decrease. As with oestrogen, peri symptoms can affect every bodily system; e.g. depression/anxiety, diminished mental function, irregular periods, hot flushes, sleep problems, vaginal atrophy \& urinary urgency. These symptoms are linked with lower quality of life \& significantly higher work impairment; a third experiencing symptoms so severe as to impede daily life \& increase risk of suicide. Lifetime increased risks of diabetes, heart disease, osteoporosis \& dementia are also associated with menopause, yet it remains disconcertingly poorly studied. The investigators propose to create a world-first, cutting-edge, consumer-driven, Virtual peri-/menopause registry of AusTrALia (VITAL). The unique design will enable consumers to determine VITAL's questions, encourage secure revelation of private data e.g. vaginal \& mental health symptoms, \& to direct priorities for research, education, \& health service improvements. VITAL will thus deliver optimal assessments of incidence, prevalence \& impact. The participating consumers, researchers, clinical specialists, policy makers, \& modern virtual data infrastructure enable this unique \& innovative registry design, future translation to improved community health, \& promote awareness \& collaborative synergies. Leveraging the investigators' critical range of expertise \& ongoing feedback opportunities for both participants \& stakeholder partnerships, the investigators will create a ground-breaking platform that:
- empowers the consumer voice and priorities,
- enables peri-/menopause research to extend beyond existing niche focuses,
- evidences the true impact of peri-/menopause across the nation,
- evolves healthcare services and outcomes, \&
- educates community, clinicians, \& policy-makers. After Australian registry establishment, the investigators will expand VITAL to mirror it in other nations while still protecting individual's data the right way, but so all can learn \& apply the best aspects of care from across the world.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2023
CompletedFirst Submitted
Initial submission to the registry
August 14, 2023
CompletedFirst Posted
Study publicly available on registry
July 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2073
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2073
July 5, 2024
July 1, 2024
50 years
August 14, 2023
July 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Australian peri-/menopause experience as measured by qualitative self-report generated via participation & feedback of a critical mass of at least 10,000 registry participants, broadly representative of the Australian population.
Determination of the Australian peri-/menopause experience.
Through input completion per participant, an average of 4 years
Secondary Outcomes (1)
Registry feasibility as measured by numbers of registry entries.
Through study completion, ongoing at least quarterly for a minimum of 10 years post-registry commencement.
Study Arms (4)
Menopause/Post-menopause
Menopause/Post-menopause, born with ovaries
Peri-menopause
Peri-menopause, born with ovaries
Pre-menopause
Pre-menopause, born with ovaries
Other
Not born with ovaries
Interventions
Registry participants may select to be contacted for future research and/or embedded clinical trials. Such interventions will require associated ethics review \& approval.
Eligibility Criteria
Although most questions are targeted towards those in peri-/menopause, other members from the community, clinical, research, employment or other areas can also provide valuable input through participative responses to a smaller number of questions. Note "Australian" includes Australian residents utilising the Australian healthcare system.
You may qualify if:
- Any Australian over 18 years of age.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bespoke Clinical Research. Community-driven from every Australian across the country. Registry led from Adelaide
Adelaide, Australia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Erin B Morton, PhD,Medicine
Bespoke Clinical Research
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 50 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 14, 2023
First Posted
July 5, 2024
Study Start
August 3, 2023
Primary Completion (Estimated)
August 1, 2073
Study Completion (Estimated)
August 1, 2073
Last Updated
July 5, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Start dates: As appropriate to minimum data level reached for the question of interest. End dates: At end of registry unless particular parameters are removed via amendment during annual conduct, whereupon 15 years after final collection.
- Access Criteria
- Detailed requests must be submitted with ethics approval to the VITAL Steering Committee for review consideration. Sharing will be on hold by default until otherwise specified in VITAL information including public-facing webpage. Only IPD with individual-level consent will be shared. Otherwise any sharing and/or publication of VITAL data will be deidentified and/or aggregated as appropriate. Upon reaching internally-defined minimum data levels, more information on the IPD sharing request processes will be made available on the VITAL website.
Individual Participant Data collected during the trial may be shared but only if that individual participant specifically consented to it, \& only after approval decisions from both Ethics Committee \& VITAL Steering Committee review. Otherwise any sharing and/or publication of this data will be deidentified and/or aggregated as appropriate.