Clinical trial NCT06487130: Virtual perI-/Menopause Registry of AusTrALia
Official title: Virtual perI-/Menopause Registry of AusTrALia
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Bespoke Clinical Research
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Although most questions are targeted towards those in peri-/menopause, other members from the community, clinical, research, employment or other areas can also provide valuable input through participative responses to a smaller number of questions.

Note "Australian" includes Australian residents utilising the Australian healthcare system.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Any Australian over 18 years of age.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Australian peri-/menopause experience as measured by qualitative self-report generated via participation & feedback of a critical mass of at least 10,000 registry participants, broadly representative of the Australian population.
timeFrame: Through input completion per participant, an average of 4 years
Secondary outcomes:
measure: Registry feasibility as measured by numbers of registry entries.
timeFrame: Through study completion, ongoing at least quarterly for a minimum of 10 years post-registry commencement.
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Bespoke Clinical Research. Community-driven from every Australian across the country. Registry led from Adelaide
Study officials:
affiliation: Bespoke Clinical Research
name: Erin B Morton, PhD,Medicine
role: STUDY_DIRECTOR
References: