Tailoring Online Continence Promotion for Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 445
- 试验地点
- 2
- 主要终点
- User Engagement With Online Mind Over Matter (MOM)
研究概览
简要总结
This project seeks to understand whether, and how, tailoring an online continence intervention can increase engagement and uptake of health behaviors known to improve bladder and bowel symptoms.
详细描述
The investigators will conduct a two-arm, parallel, randomized, controlled trial (RCT) comparing an online continence promotion program with standard weekly reminders (control arm) to an online continence promotion program with tailoring (treatment arm) to determine the impact of tailoring on program engagement. Women in the treatment arm will receive tailored content and digital reminders for 24 weeks based on their individual characteristics, symptoms, and behaviors assessed at baseline, with reassessment of key inputs every 2 weeks resulting in re-tailored outputs. Participants will complete electronic surveys at enrollment, 4, 12, and 24 weeks. To contextualize the findings from all 3 aims, a subset of participants will be invited to complete semi-structured qualitative interviews about their engagement with the program, their adoption of health behaviors, and their perceived barriers to and facilitators of engagement and behavior change.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •50 years or older
- •Can read & write English
- •Can use email
- •Has access to an Internet-connected device to use the online program
排除标准
- •Neurologic or musculoskeletal conditions in which pelvic floor muscle exercises are contraindicated
- •Hematuria or bloody stools within last 6 months that has not been evaluated by a medical professional
结局指标
主要结局
User Engagement With Online Mind Over Matter (MOM)
时间窗: 0-4 weeks
Proportion of participants who engage with online MOM at least 4 times during weeks 0-4 in the group with (test) and without (control) tailoring.
次要结局
- Differences in Scores of the Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q)(Baseline and 24 weeks)
- Self-reported Behavior Changes: Change in the Frequency of Pelvic Floor Muscle Exercises(Baseline, 4, 12, and 24 weeks)
- Differences in Scores of the Geriatric Index for Urinary Incontinence (GSE-UI)(Baseline, 4, and 24 weeks)
- Differences in Responses to the Generalized Self-Efficacy Scale Adapted for MOM Program(Baseline, 4, and 24 weeks)
- Program Specific Health Action Process Approach Survey Responses Reported as Binary Outcomes(Baseline, 4, and 24 weeks)
- Differences in Scores of the Barriers to Care-seeking for Accidental Bowel Leakage (BCABL)(Baseline and 24 weeks)
- Differences in Scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)(Baseline, 4, 12, and 24 weeks)
- Differences in Scores of the St. Mark's Incontinence Scale (SMIS) (Aka Vaizey)(Baseline, 4, 12, and 24 weeks)
- Differences in Scores of the Pelvic Floor Impact Questionnaire Short Form (PFIQ-7)(Baseline, 4, 12, and 24 weeks)
- Change in the Response of Global Patient Satisfaction Question (PSQ)(4 and 24 weeks)
- Change in Patient Estimated Percent Improvement (EPI)(4 and 24 weeks)
- Change in Response on Global Perception of Improvement (GPI)(4 and 24 weeks)
- Differences in Scores of the 12-item Short Form Health Survey (SF-12)(Baseline, 4, 12, and 24 weeks)