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NCT Number: NCT06487130

Virtual perI-/Menopause Registry of AusTrALia

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.

Recruiting

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Key information

Conditions

Menopause Behavior Behavioral Symptoms Bone Diseases Bone Diseases, Metabolic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Diabetes Mellitus Diabetes Mellitus Risk Diabetes Mellitus, Type 2 Economic Burden Endocrine System Diseases Financial Stress Glucose Metabolism Disorders Health Behavior Health Care Seeking Behavior Health Care Utilization Health Knowledge, Attitudes, Practice Healthy Aging Hot Flashes Hot Flushes Aggravated Menopause Related Conditions Mental Deterioration Mental Disorders Mental Health Impairment Mental Health Issue Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Perimenopausal Disorder Postmenopausal Symptoms Signs and Symptoms Social Behavior Social Stigma Stress, Psychological Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Adelaide, Australia

Location status: Recruiting

Location contact

Erin B Morton, PhD

PRINCIPAL_INVESTIGATOR

Erin Morton, PhD

CONTACT

[email protected]

0403157844

About this study

In the Virtual Peri-Menopause Registry of Australia -VITAL- the investigators will:

  • Co-create an innovative, multidisciplinary, ongoing digital epidemiological platform & repository of Australian peri-/menopausal health, centred on relevance to the community;
  • 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;
  • Determine & define community consensus priorities in related healthcare & associated policy.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any Australian over 18 years of age.

Exclusion criteria

  • None.

Treatment and study plan

N/A observational registry

Other

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

Primary outcomes

  1. 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.

    Time frame: Through input completion per participant, an average of 4 years

    Determination of the Australian peri-/menopause experience.

Secondary outcomes

  1. Registry feasibility as measured by numbers of registry entries.

    Time frame: Through study completion, ongoing at least quarterly for a minimum of 10 years post-registry commencement.

    Registry feasibility shown by increasing Australian participation

Study contacts

Contact information is provided by the study sponsor or research team.

Erin B Morton, PhD,Medicine

CONTACT

[email protected]

+61403157844

VITAL Peri-/Menopause Registry

CONTACT

[email protected]

+61403157844

Sponsors and collaborators

Lead sponsor

Bespoke Clinical Research

Industry

Registry information

Acronym: VITAL

Important dates

Study start
2023
Primary completion
2073
Study completion
2073
First posted
Jul 5, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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