Virtual perI-/Menopause Registry of AusTrALia
NCT Number: NCT06487130
Acronym: VITAL
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Menopause|Perimenopausal Disorder|Postmenopausal Symptoms|Health Knowledge, Attitudes, Practice|Healthy Aging|Health Care Utilization|Health Care Seeking Behavior|Mental Health Impairment|Mental Deterioration|Mental Health Issue|Osteoporosis, Postmenopausal|Diabetes Mellitus Risk|Diabetes Mellitus, Type 2|Dementia|Cardiovascular Diseases|Menopause Related Conditions|Hot Flashes|Hot Flushes Aggravated|Economic Burden|Social Stigma
Interventions: OTHER: N/A Observational Registry
Sponsor: Bespoke Clinical Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-03
Completion Date: 2073-08
Locations: Bespoke Clinical Research. Community-driven from every Australian across the country. Registry led from Adelaide, Adelaide, Australia

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.

Primary Outcome Measures: 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 Outcome Measures: Registry feasibility as measured by numbers of registry entries., Registry feasibility shown by increasing Australian participation, Through study completion, ongoing at least quarterly for a minimum of 10 years post-registry commencement.