Virtual perI-/Menopause Registry of AusTrALia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any Australian over 18 years of age.
排除标准
- 未提供
结局指标
主要结局
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.
时间窗: Through input completion per participant, an average of 4 years
Determination of the Australian peri-/menopause experience.
次要结局
- Registry feasibility as measured by numbers of registry entries.(Through study completion, ongoing at least quarterly for a minimum of 10 years post-registry commencement.)
研究者
Erin Morton
Associate Professor
Bespoke Clinical Research