Virtual perI-/Menopause Registry of AusTrALia
NCT06487130 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000
Last updated 2024-07-05
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.
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
Registry participants may select to be contacted for future research and/or embedded clinical trials. Such interventions will require associated ethics review \& approval.
Sponsors & Collaborators
-
Bespoke Clinical Research
lead INDUSTRY
Principal Investigators
-
Erin B Morton, PhD,Medicine · Bespoke Clinical Research
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-08-03
- Primary Completion
- 2073-08-31
- Completion
- 2073-08-31
Countries
- Australia
Study Locations
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