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Recruiting NCT06487130

Virtual perI-/Menopause Registry of AusTrALia

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

Sponsor: Bespoke Clinical Research

trial.available_in: БГ
Overview
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.
Description
In the Virtual Peri-Menopause Registry of Australia -VITAL- the investigators will: 1. Co-create an innovative, multidisciplinary, ongoing digital epidemiological platform \& repository of Australian peri-/menopausal health, centred on relevance to the community; 2. Establish incidence, prevalence \& impact of Australian peri-/menopause symptomology, associated disease risk factors, \& healthcare system pathways, via secure participant input, encouraging safe revelation of personal data, e.g. symptoms, impairment, substandard care; 3. Determine \& define community consensus priorities in related healthcare \& associated policy. 4. Disseminate not only results, but ensure accessibility of the data from the national registry to authorised, relevant \& ethical investigations to streamline research \& in turn, translate to community healthcare outcomes, e.g. community education, clinical advice, policies, data linkage with significant datasets and/or registries e.g. cardiac, cancer, ageing, Medicare etc.
Who can participate
Inclusion Criteria: * Any Australian over 18 years of age. Exclusion Criteria: * None.
Locations 1
Australia (1)
Bespoke Clinical Research. Community-driven from every Australian across the country. Registry led from Adelaide
Adelaide
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.08.2023
Completion date
01.08.2073
Registry ID
NCT06487130
Source
anzctr
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