Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women

Aida Jaffar, Sherina Mohd Sidik, Chai Nien Foo, Noor Azimah Muhammad, Rosliza Abdul Manaf, Siti Irma Fadhilah Ismail, Nazhatussima Suhaili, Aida Jaffar, Sherina Mohd Sidik, Chai Nien Foo, Noor Azimah Muhammad, Rosliza Abdul Manaf, Siti Irma Fadhilah Ismail, Nazhatussima Suhaili

Abstract

Background: The delivery of pelvic floor muscle training (PFMT) through mHealth apps has been shown to produce promising results in improving pelvic floor muscle strength and urinary incontinence (UI). However, there is limited evidence on mHealth apps designed for pregnant women who are at high risk of developing UI. This pilot study aims to evaluate the feasibility of conducting an effectiveness trial for a newly developed PFMT app among pregnant women in Malaysia.

Methods: This is a prospective, single-centre, single-blind, randomised controlled pilot feasibility study: The Kegel Exercise Pregnancy Training app (KEPT-app) Trial. Sixty-four incontinent pregnant women who attended one primary care clinic for the antenatal follow-up will be recruited and randomly assigned to either intervention or waitlist control group. The intervention group will receive the intervention, the KEPT-app developed from the Capability, Opportunity, Motivation-Behaviour (COM-B) theory with Persuasive Technology and Technology Acceptance Model.

Discussion: This study will provide a fine-tuning for our future randomised control study on the recruitment feasibility methods, acceptability, feasibility, and usability of the KEPT-app, and the methods to reduce the retention rates among pregnant women with UI.

Trial registration: This study was registered on ClinicalTrials.gov on 19 February 2021 (NCT04762433) and is not yet recruiting.

Keywords: behavioural change theory; mHealth app; mobile application; pelvic floor muscle training; pilot feasibility study; pregnancy; randomized control trial; urinary incontinence.

Conflict of interest statement

The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
Pilot study flowchart.
Figure 2
Figure 2
Conceptual framework of KEPT-app.

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