Ignite Creation Date:
2024-07-17 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487130
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-08-14
Brief Title:
Virtual perI-Menopause Registry of AusTrALia
Sponsor:
Bespoke Clinical Research
Organization:
Bespoke Clinical Research
Study Overview
Official Title:
Virtual perI-Menopause Registry of AusTrALia
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITAL
Brief Summary:
13 million 507 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 eg depressionanxiety 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 VITALs questions encourage secure revelation of private data eg 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 individuals data the right way but so all can learn apply the best aspects of care from across the world
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 VITALs questions encourage secure revelation of private data eg 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 individuals 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 eg 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 eg community education clinical advice policies data linkage with significant datasets andor registries eg cardiac cancer ageing Medicare etc
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 eg 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 eg community education clinical advice policies data linkage with significant datasets andor registries eg cardiac cancer ageing Medicare etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None