Virtual perI-/Menopause Registry of AusTrALia

NCT06487130 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2024-07-05

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06487130 on ClinicalTrials.gov