Virtual perI-/Menopause Registry of AusTrALia (VITAL)

Bespoke Clinical Research

Status: Enrolling

Conditions: Menopause; Cardiovascular Diseases; Postmenopausal Symptoms; Diabetes Mellitus, Type 2; Health Care Utilization; Osteoporosis, Postmenopausal; Menopause Related Conditions; Health Care Seeking Behavior; Hot Flushes Aggravated; Social Stigma; Economic Burden; Perimenopausal Disorder; Mental Health Issue; Mental Health Impairment; Hot Flashes; Mental Deterioration; Diabetes Mellitus Risk; Health Knowledge, Attitudes, Practice; Dementia; Healthy Aging

Treatments: Other: N/A Observational Registry

Study type: Observational

Funder types: Industry

Identifiers

NCT06487130

VITAL-Oz

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any Australian over 18 years of age.

Exclusion criteria

• None.

Trial design

10,000 participants in 4 patient groups

Menopause/Post-menopause

Description:

Menopause/Post-menopause, born with ovaries

Treatment:

Other: N/A Observational Registry

Peri-menopause

Description:

Peri-menopause, born with ovaries

Treatment:

Other: N/A Observational Registry

Pre-menopause

Description:

Pre-menopause, born with ovaries

Treatment:

Other: N/A Observational Registry

Other

Description:

Not born with ovaries

Treatment:

Other: N/A Observational Registry