Virtual perI-/Menopause Registry of AusTrALia

NCT ID: NCT06487130

Last Updated: 2024-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-03

Study Completion Date

2073-08-31

Brief Summary

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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

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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

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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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Menopause/Post-menopause

Menopause/Post-menopause, born with ovaries

N/A Observational Registry

Intervention Type OTHER

Registry participants may select to be contacted for future research and/or embedded clinical trials. Such interventions will require associated ethics review \& approval.

Peri-menopause

Peri-menopause, born with ovaries

N/A Observational Registry

Intervention Type OTHER

Registry participants may select to be contacted for future research and/or embedded clinical trials. Such interventions will require associated ethics review \& approval.

Pre-menopause

Pre-menopause, born with ovaries

N/A Observational Registry

Intervention Type OTHER

Registry participants may select to be contacted for future research and/or embedded clinical trials. Such interventions will require associated ethics review \& approval.

Other

Not born with ovaries

N/A Observational Registry

Intervention Type OTHER

Registry participants may select to be contacted for future research and/or embedded clinical trials. Such interventions will require associated ethics review \& approval.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Any Australian over 18 years of age.

Exclusion Criteria

* None.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bespoke Clinical Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Erin Morton

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erin B Morton, PhD,Medicine

Role: STUDY_DIRECTOR

Bespoke Clinical Research

Locations

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

Adelaide, , Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Erin B Morton, PhD,Medicine

Role: CONTACT

+61403157844

VITAL Peri-/Menopause Registry

Role: CONTACT

+61403157844

Facility Contacts

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Erin Morton, PhD

Role: primary

0403157844

Related Links

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https://bespokeclinicalresearch.com.au/vitalimpact/

VITAL Research: co-creating healthcare improvement.

Other Identifiers

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VITAL-Oz

Identifier Type: -

Identifier Source: org_study_id

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