NCT01858493已完成不适用
Phase 3 Cluster Randomised Trial Testing the Efficacy of a Continence Promotion Intervention to Improve Urinary Symptoms and Quality of Life, and Reduce Stigma and Falls in Older Community-dwelling Women With Untreated Incontinence
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal8 个研究点 分布在 3 个国家目标入组 910 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 910
- 试验地点
- 8
- 主要终点
- Self-reported improvement in urinary incontinence
研究概览
简要总结
To determine whether women exposed to the continence promotion intervention will report improved urinary symptoms and quality of life, and lower incontinence-related stigma and falls than women who receive a control intervention at one-year post-intervention.
详细描述
This is a cluster-randomized 4-site intervention study testing the effect of a continence-promotion intervention on:
- Improved urinary symptoms and quality of life
- Reduction in falls
- Reduction in stigma
A cost-effectiveness component will also be included
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •65 years and older
- •Urinary incontinence at least once weekly
排除标准
- •Living in residential or long-term care
- •Received treatment for incontinence within the past year
- •Dementia or other neurological conditions that preclude the ability to provide -Informed consent
结局指标
主要结局
Self-reported improvement in urinary incontinence
时间窗: 1 year
Patient global impression of improvement questionnaire Sandvik severity index ICIQ-FLUTS
次要结局
- Reduction in incontinence related stigma and quality of life(1 year)
- Falls(1 year)
研究者
Cara Tannenbaum
Principal Investigator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
研究点 (8)
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