Virtual perI-/Menopause Registry of AusTrALia (VITAL)

July 2, 2024 updated by: Erin Morton, Bespoke Clinical Research

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Adelaide, Australia
        • Recruiting
        • Bespoke Clinical Research. Community-driven from every Australian across the country. Registry led from Adelaide
        • Contact:
        • Principal Investigator:
          • Erin B Morton, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • Any Australian over 18 years of age.

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Menopause/Post-menopause
Menopause/Post-menopause, born with ovaries
Other: 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.
Peri-menopause
Peri-menopause, born with ovaries
Other: 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.
Pre-menopause
Pre-menopause, born with ovaries
Other: 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.
Other
Not born with ovaries
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through input completion per participant, an average of 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, ongoing at least quarterly for a minimum of 10 years post-registry commencement.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bespoke Clinical Research

Investigators

  • Study Director: Erin B Morton, PhD,Medicine, Bespoke Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2023

Primary Completion (Estimated)

August 1, 2073

Study Completion (Estimated)

August 1, 2073

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

July 2, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITAL-Oz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual Participant Data collected during the trial may be shared but only if that individual participant specifically consented to it, & only after approval decisions from both Ethics Committee & VITAL Steering Committee review. Otherwise any sharing and/or publication of this data will be deidentified and/or aggregated as appropriate.

IPD Sharing Time Frame

Start dates: As appropriate to minimum data level reached for the question of interest.

End dates: At end of registry unless particular parameters are removed via amendment during annual conduct, whereupon 15 years after final collection.

IPD Sharing Access Criteria

Detailed requests must be submitted with ethics approval to the VITAL Steering Committee for review consideration. Sharing will be on hold by default until otherwise specified in VITAL information including public-facing webpage. Only IPD with individual-level consent will be shared. Otherwise any sharing and/or publication of VITAL data will be deidentified and/or aggregated as appropriate. Upon reaching internally-defined minimum data levels, more information on the IPD sharing request processes will be made available on the VITAL website.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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