Kegel Exercise Pregnant Training mHealth App

Study Overview
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Brief Summary
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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
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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.

Official Title
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Parallel-Group, Randomised Single-centred, Single-blind, Pilot and Feasibility Study for KEPT-app Trial: Study Protocol

Conditions
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Pregnancy Related, Urinary Incontinence

Intervention / Treatment
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* Device: Kegel Exercise Pregnancy Training - app


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will use a single-blind, single-centre, parallel, randomized controlled trial (RCT) design which will incorporate individualised treatment flexibility, as in a real-world setting, and provide a realistic estimation in future KEPT-app RCT study (Sidik et al., 2021).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kegel Exercise Pregnancy Training - App<br>The intervention arm will be given a mHealth app for two months duration with the usual antenatal follow-up. | Device: Kegel Exercise Pregnancy Training - app<br>* KEPT-app is designed to educate pregnant women on PFMT via the step-by-step training with the capability element to improve their confidence and skills (beginner, intermediate and advance skills). Pregnant women are encouraged to continue adopt the PFMT throughout pregnancy until postpartum period. The details of the mHealth app content was developed based on the need assessment gathered from the cross-sectional study (Jaffar et al., 2020). It was conducted to identify the need of PFMT by looking at the prevalence of the UI among pregnant women and to understand their knowledge, attitude, and practices towards PFMT.<br>|
| No Intervention: Waitlist control<br>The control (waitlist) group will continue their usual antenatal follow-up and the KEPT-app will be given after the study ends. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the mHealth app intervention. | Interactive Malay-mHealth App Usability Questionnaire Standardized outcome measure with additional Qualitative data collection How many stars would you recommend this app to your friends? How many stars would you rate the content of this app? How many stars would you rate the comfort of using this app? How many stars would you rate simplicity using this app? How many stars would you rate the recruitment process using this app? How many stars would you rate the quality of the app? Factors influenced/hindered using this app? What motivates you to continue the PFMT? (Further information will be collected via qualitative data feedback) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of educational video | Patient Educational Material Assessment Tool (PEMAT) Standardized outcome measure | 1 month | 
| Kegel's exercise adherence | Exercise Adherence Rating Scale Standardized outcome measure where the increasing PFMT adherence from lowest score (0) to maximum score (24) of Exercise Adherence Rating Scale (EARS) Increasing Exercise adherence from lowest score (0) to maximum score (24). | 1 month and 2 months | 
| Self-efficacy towards Kegel's Exercise | Self-Efficacy Scale For Practicing Pelvic Floor Exercise Questionnaire Standardized outcome measure The final scores were obtained by calculating the mean of the items, ranging between 0 and 100, in which the higher values were equivalent to higher self-efficacy in practising PFME. | 1 month and 2 months | 
| Urinary incontinence | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) The overall score is between 0 and 21 whereby greater values of the overall scores indicated increased severity of UI. | 1 month and 2 months | 
| Knowledge, Attitude and Practice Pelvic Floor Muscle Training | The overall knowledge scores ranged between 0 and 14, and a higher score suggested a higher level of knowledge. The total scores for attitude ranged between 8 and 40, with higher scores suggesting a positive attitude. The total scores for the practice domain ranged between 4 and 16, and the higher score suggested higher levels of its practice. | 1 month and 2 months | 
| Quality of Life of pregnant women | The minimum mark was 19 and the maximum mark was 76 indicating severely affecting QOL using the Incontinence Impact Questionnaire Quality of Life (ICIQ-LUTSqol). | 1 month and 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilot study, Feasibility study, Acceptability, mHealth app, Pelvic Floor Muscle Training