Virtual perI-/Menopause Registry of AusTrALia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBespoke Clinical Research

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Any Australian over 18 years of age.

Disqualifiers

None.

Trial population

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.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • N/A Observational Registry

    Other intervention

    Registry participants may select to be contacted for future research and/or embedded clinical trials. Such interventions will require associated ethics review \& approval.

Treatment groups

10,000 Participants
are divided into 4 treatment groups
Group A: Menopause/Post-menopause1 intervention
Group B: Peri-menopause1 intervention
Group C: Pre-menopause1 intervention
Group D: Other1 intervention

Trial outcomes

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.

Time frame
Through input completion per participant, an average of 4 years

Secondary outcomes

1

Registry feasibility as measured by numbers of registry entries.

Registry feasibility shown by increasing Australian participation

Time frame
Through study completion, ongoing at least quarterly for a minimum of 10 years post-registry commencement.

Other outcomes

Sponsors and contacts

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