Kegel Exercise Pregnant Training mHealth App

March 22, 2022 updated by: Aida Jaffar, Universiti Putra Malaysia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Hulu Langat, Selangor, Malaysia, 43200
        • (Health Clinic Ampang) Ministry of Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kegel Exercise Pregnancy Training - App
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

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.
No Intervention: Waitlist control
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of educational video
Time Frame: 1 month
Patient Educational Material Assessment Tool (PEMAT) Standardized outcome measure
1 month
Kegel's exercise adherence
Time Frame: 1 month and 2 months
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
Time Frame: 1 month and 2 months
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
Time Frame: 1 month and 2 months
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
Time Frame: 1 month and 2 months
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
Time Frame: 1 month and 2 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Investigators

  • Principal Investigator: Sherina Mohd Sidik, PhD, Universiti Putra Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2021

Primary Completion (Actual)

November 17, 2021

Study Completion (Actual)

November 17, 2021

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR-19-471-45606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be collected via the KEPT-app link entered directly into the trial database. Data gathered from the KEPT-app enables the participants to access their data, monitor their UI symptoms and act as PFMT motivation. The data will be stored in the cloud-based Azure storage.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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