Trials / Recruiting

RecruitingNCT06487130

Virtual perI-/Menopause Registry of AusTrALia

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 10,000 (estimated)

Sponsor: Bespoke Clinical Research · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2023-08-03
Primary completion: 2073-08-01
Completion: 2073-08-01
First posted: 2024-07-05
Last updated: 2024-07-05

Locations

1 site across 1 country: Australia

Source: ClinicalTrials.gov record NCT06487130. Inclusion in this directory is not an endorsement.