Virtual perI-/Menopause Registry of AusTrALia

Last updated: July 2, 2024
Sponsor: Bespoke Clinical Research
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Dementia

Menopause

Treatment

N/A Observational Registry

Clinical Study ID

NCT06487130
VITAL-Oz
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any Australian over 18 years of age.

Exclusion

Exclusion Criteria:

  • None.

Study Design

Total Participants: 10000
Treatment Group(s): 1
Primary Treatment: N/A Observational Registry
Phase:
Study Start date:
August 03, 2023
Estimated Completion Date:
August 31, 2073

Study 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.

Connect with a study center

  • Bespoke Clinical Research. Community-driven from every Australian across the country. Registry led from Adelaide

    Adelaide,
    Australia

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.