Parallel-Group, Randomised Single-centred, Single-blind, Pilot and Feasibility Study for KEPT-app Trial: Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Acceptability of the mHealth app intervention.
研究概览
简要总结
This pilot feasibility study protocol is to assess the feasibility in the future definitive trial that is the Kegel Exercise Pregnancy Training app (KEPT-app) trial. The aim of this study as follows: (1) to evaluate the recruitment capability of the pregnant women, (2) to evaluate the acceptability of the KEPT-app, (3) to determine the implementation feasibility of using KEPT-app, and (4) to determine the preliminary effectiveness of KEPT-app to improve PFMT skills of pregnant women.
详细描述
The aim of this pilot feasibility study as follows: (1) to evaluate the recruitment capability of the pregnant women, (2) to evaluate the acceptability of the KEPT-app, (3) to determine the implementation feasibility of using KEPT-app, and (4) to determine the preliminary effectiveness of KEPT-app to improve PFMT skills of pregnant women.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator and the assessor will be blinded as to the recruitment and allocation via the electronic consent format and the intervention via the mobile application.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at 26-27 weeks of gestation, any parity with either stress UI or mixed UI will be included.
- •Participants are Malaysian citizens who consist of Malay, Chinese, Indian, and native ethnicities.
排除标准
- •pregnant women with a chronic medical problem(s) before pregnancy, complicated pregnancies or conditions which are not advisable to practise PFMT will be excluded.
结局指标
主要结局
Acceptability of the mHealth app intervention.
时间窗: 2 months
Interactive Malay-mHealth App Usability Questionnaire Standardized outcome measure with additional Qualitative data collection 1. How many stars would you recommend this app to your friends? 2. How many stars would you rate the content of this app? 3. How many stars would you rate the comfort of using this app? 4. How many stars would you rate simplicity using this app? 5. How many stars would you rate the recruitment process using this app? 6. How many stars would you rate the quality of the app? 7. Factors influenced/hindered using this app? 8. What motivates you to continue the PFMT? (Further information will be collected via qualitative data feedback)
次要结局
- Validation of educational video(1 month)
- Self-efficacy towards Kegel's Exercise(1 month and 2 months)
- Urinary incontinence(1 month and 2 months)
- Kegel's exercise adherence(1 month and 2 months)
- Knowledge, Attitude and Practice Pelvic Floor Muscle Training(1 month and 2 months)
- Quality of Life of pregnant women(1 month and 2 months)
研究者
Aida Jaffar
Investigator and Family Medicine Specialist, PhD Doctorate, Psuchiatry Department
Universiti Putra Malaysia