Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 23, 2020
Date Accepted: Nov 30, 2020
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A Mobile App-based Intervention for Pregnant Women With Stress Urinary Incontinence: Protocol for a Hybrid Effectiveness-Implementation Trial
ABSTRACT
Background:
Stress urinary incontinence (SUI) is a common distress among women during and after pregnancy. It has a negative effect on quality of life but with poor care-seeking. Mobile health (mHealth) may be a promising solution with potential advantages. However, there is uncertainty whether mobile app is effective for SUI symptom improvement during and after pregnancy. The implementation is also unclear. We developed an app named UIW aimed to improve perinatal incontinence.
Objective:
The objective of this study is to evaluate the effectiveness of the UIW app-based intervention in improving SUI symptom among pregnant women and explore the facilitators and barriers to using the UIW app to help refine and optimize the intervention.
Methods:
This study is a hybrid effectiveness-implementation trial with a randomized controlled trial alongside a mixed methods process evaluation according to the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. Pregnant women with SUI (n=336) will be recruited from a university-affiliated hospital in China. They will be randomly allocated (1:1) to either the intervention group that receive usual care plus UIW app or control group that receive usual care alone. The intervention period will last 3 months. Five dimensions of RE-AIM framework will be evaluated at recruitment (-T1), baseline (T0), immediately after intervention (T1), 42 days after delivery (T2), 3 months after delivery (T3) and 6 months after delivery (T4) through project documents, online questionnaires, surface electromyography, log data of background management system and qualitative interview. Data analysis will follow the intention-to-treat principle. Descriptive statistics, t-test, chi-square test and linear mixed model (LMM) will be used to analyze the quantitative data. Inductive content analysis will be used to analyze the qualitative data.
Results:
The effectiveness-implementation trial started on June 2020, trial recruitment will be completed in September 2020 and intervention will last for a 3-month period. Completion of 6-month follow-up will be in July 2021 and we anticipate that the result of this study will be published in December 2021.
Conclusions:
This study will evaluate both effectiveness and implementation of the UIW app-based intervention among pregnant women. The hybrid effectiveness-implementation trial design according to the RE-AIM framework with mixed methods approach adopted will give valuable insights into the effects as well as facilitators and barriers to the implementation that will influence the effects of the UIW app-based intervention. Clinical Trial: Chinese Clinical Trial Registry (ChiCTR) ChiCTR1800016171; http://www.chictr.org.cn/showproj.aspx?proj=27455
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