Parallel-Group, Randomised Single-centred, Single-blind, Pilot and Feasibility Study for KEPT-app Trial: Study Protocol
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pregnancy Related
- Sponsor
- Universiti Putra Malaysia
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Acceptability of the mHealth app intervention.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Aida Jaffar
Investigator and Family Medicine Specialist, PhD Doctorate, Psuchiatry Department
Universiti Putra Malaysia
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •pregnant women with a chronic medical problem(s) before pregnancy, complicated pregnancies or conditions which are not advisable to practise PFMT will be excluded.
Outcomes
Primary Outcomes
Acceptability of the mHealth app intervention.
Time Frame: 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)
Secondary Outcomes
- 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)