| BackgroundUrinary incontinence(UI)has a high prevalence with profound impacts among women during peripartum.With the rapidly-evolving of mobile health(mHealth),mobile application(APP)-based self-management program for UI in elderly women has shown effectiveness in several studies.However,its application and evaluation in women during and after pregnancy needs to be further studied.ObjectivesBased on the Urinary Incontinence for Women(UIW)APP,which our research team developed before for self-management of maternal UI,this study will complete the optimization of UIW APP.Besides,the effectiveness and process evaluation of upgraded version of UIW APP-based intervention will be performed.Methods1.Optimization of maternal UI self-management APPThrough the scoping review of literature and online APP stores,we searched the literature on APP-based self-management for UI from the establishment of the databases to March 2020 and commercially available APP for free in Apple App Store and Google Play Store.After systematic analysis for functions of APP,the optimization requirements were identified.The maternal UI self-management UIW APP was optimized and tested in collaboration with software engineer team.2.Effectiveness evaluation of APP-based maternal UI self-management programAccording to the RE-AIM Qualitative Evaluation for Systematic Translation(RE-AIM QuEST)framework,we applied the mixed methods research to evaluate the effectiveness.By adopting the randomized controlled trial(RCT)design,pregnant women from a hospital in Shenzhen were conveniently sampled from June 2020 to October 2020 and then randomly assigned to intervention group and control group.The intervention lasted for a 2-month period.The control group received the usual care.The intervention group received the usual care plus UIW APP-based intervention.The quantitative outcomes included UI prevalence,UI severity,UI-related quality of life,pelvic floor muscle training(PFMT)self-efficacy,and UI knowledge to explore the effect size.Qualitative interviews after the intervention were performed in the intervention group to explore the effect mechanism.Triangulation protocol was used to integrate the quantitative and qualitative results.3.Process evaluation of APP-based maternal UI self-management programAccording to the RE-AIM QuEST framework,we applied the mixed methods research to evaluate the reach,adoption,implementation and maintenance of the UIW APP-based intervention.The process evaluation was performed in parallel with the effectiveness evaluation.The quantitative outcomes included participation rate,adoption of the UIW APP,fidelity of PFMT,sustainability adoption and recommendation intention in the future to explore the implementation process.Qualitative interviews after the intervention were performed to explore the facilitators and barriers to the implementation process.Triangulation protocol was used to integrate the quantitative and qualitative results.Results1.Optimization of maternal UI self-management APPBased on the scoping review,we systematically analyzed the functions of UI self-management APP and identified the optimization requirements to complete the optimization of UIW APP.There were 24 changes totally to improve the ease of use and user friendliness,information openness and transparency and credibility,simplicity and vitality of interface design,interaction,monitoring and traceability,novelty and comprehensiveness of content and privacy policy.After test and update in the APP stores,the updated version of UIW APP could be used in the following evaluation.2.Effectiveness evaluation of APP-based maternal UI self-management programThe RCT recruited 126 pregnant women.The results showed that UI prevalence and severity,UI-related quality of life,PFMT self-efficacy and UI knowledge in intervention group were improved compared to the control group after the 2-month intervention(P<0.05).At the 42 days postpartum,there was no significant difference in prevalence of UI between the two groups(P>0.05),while the UI severity,UI-related quality of life;PFMT self-efficacy and UI knowledge were improved in the intervention group compared to the control group(P<0.05).18 participants in the intervention group were interviewed and qualitative interviews indicated that women regarded the UIW APP as a knowledge base,the UIW APP enhanced the individual motivation and efficacy and promoted the PFMT behaviors for UI self-management.The integration of quantitative and qualitative results showed the confirmation and expansion between the results.3.Process evaluation of APP-based maternal UI self-management programThe process evaluation showed that the participation rate was 79.2%.The mean logins per day was 2.51(SD 1.72)in one participant,mean reads per article was 54.58(SD 45.94),mean watches per video was 43.82(SD 38.02),and mean exercises and usage minutes per day in one participant was 2.87(SD 0.69)and 7.59(SD 6.83),respectively.The fidelity of PFMT was 89.7%.The ten levels Likert scale indicated mean overall quality of UIW APP was 8.00(SD 1.15).91.4%of the participants had the intention of sustainability adoption and 87.9%of the participants had the recommendation intention to others in the future.Qualitative interviews showed that there were various facilitators and barriers to the implementation process of UIW APP-based intervention.The integration of quantitative and qualitative results showed the confirmation and expansion between the results.ConclusionsThe scoping review was performed to systematically analyze the functions of UI self-management APP in the literature and online APP stores,which provided the guide of the UIW APP optimization.Through the clinical application,the effectiveness evaluation indicates UIW APP-based self-management program is effective in improving UI symptom,UI-related quality of life,PFMT self-efficacy,and UI knowledge.However,barriers to the clinical application process need to be addressed to provide support for further scale-up in the future.Adopting mixed methods research also strengthen the understanding of the effectiveness and process evaluation. |
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