Self-management, Constructivism or Both as Knowledge Transfer Strategies for Reducing the Cost and Impact of Urinary Incontinence Among Community-dwelling Senior Women in the United Kingdom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 259
- 试验地点
- 2
- 主要终点
- Incontinence frequency
研究概览
简要总结
Urinary incontinence is a common and bothersome condition that remains frequently untreated among senior women. The aim of this trial is to compare the effectiveness of two community-based continence promotion interventions aimed at improving rates of self-care and/or professional health-care seeking in older women with urinary incontinence. The main hypothesis posits that participation in a constructivist interactive workshop combined with use of an evidence-based self-management tool will yield rates of improvement in incontinence frequency and reduce the cost of pad use by 20% compared to either intervention alone, which individually are expected to yield minimal effect sizes of at least 0.3 compared to a sham intervention.
详细描述
The research design is a 2x2 factorial open-label cluster randomised controlled trial. The cluster (unit of randomization) is at the level of each local community senior's group, from whence participants will be recruited. Incontinent community-dwelling older women aged 60 years and older who have not sought care for their urinary symptoms in the last two years, but who experience incontinence at least twice weekly will be recruited through local community organizations. Eligible participants from each local community centre will be randomly assigned as a group to one of four interventions. The first intervention is participation in an interactive constructivist continence workshop. The second intervention involves receipt of an evidence-based self-management tool for incontinence. The third group will receive both interventions. The fourth group will act as the control group: they will simply be asked about their urinary symptoms and given a general talk on women's health. At the end of the study, the control group will be offered the self-management tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •60 years or older
- •Urinary incontinence twice weekly
- •Women who have not sought medical advice for incontinence symptoms in the last 2 years.
- •Fluent in English
排除标准
- •Women who have received treatment for their urinary incontinence within the past two years from a health care provider with expertise in urinary incontinence management (i.e. nurse practitioners/physicians/surgeons who have a clinical practice that focuses on treating urinary incontinence).
- •Women started on medications for urinary incontinence (i.e. antimuscarinic medication) within the 6 months prior to enrolment.
- •Women with a history of a neurological condition (e.g. Multiple Sclerosis and spinal cord injury) because they require further investigation. Women identified to have these historical findings will be advised to speak to their physician immediately about their incontinence and the possible need for investigation.
- •Women who do not consent to participate.
结局指标
主要结局
Incontinence frequency
时间窗: 3 months
Reductions in incontinence frequency as indicated on a 72-hour voiding diary at 3-months post-intervention compared to baseline.
次要结局
- Self-efficacy for managing incontinence(3-months)
- Cost of pad use(3 months)
研究者
Cara Tannenbaum
Dr.
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal