RISE FOR HEALTH Study by the PLUS Consortium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,400
- 试验地点
- 9
- 主要终点
- Bladder Health Scales and Function Indices
研究概览
简要总结
The RISE FOR HEALTH study (RISE) is an initiative of the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium, which was formed by the NIDDK in 2015 to develop the science to improve bladder health in women and girls. RISE is designed to identify risk and protective factors for bladder health and lower urinary tract symptoms (LUTS) and to estimate the distributions of bladder health and bladder health knowledge, attitudes, and beliefs in women of all ages across the life course.
This will be accomplished by conducting a population-based prospective cohort study. A sample of individuals who live within the study base, i.e., the county containing each PLUS clinical research center and each adjacent county, will be invited to complete two baseline surveys and then two follow-up surveys one year later. A subset of participants will be invited to attend an in-person evaluation to collect additional clinical information and biologic specimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Community dwelling
- •Age ≥18 years
- •Identify or born as female (includes cis- and trans-women, and trans-men)
- •Able to read and understand English or Spanish
- •Able to read and provide informed consent
排除标准
- •Physical or mental health conditions that would prohibit self-administration of questionnaires either electronically or using paper and pencil (e.g., dementia/cognitive impairment/blindness/severe arthritis).
- •Residence in a nursing home or other institutionalized living facility.
结局指标
主要结局
Bladder Health Scales and Function Indices
时间窗: Baseline assessment
Multi-item measurement to assess bladder health comprised of subscales and indices ranging from zero to 100
次要结局
- Knowledge, Attitudes and Beliefs (KAB)(Baseline assessment)
- Change in Bladder Health Scales and Function Indices(1 year follow-up from baseline assessment)