Mobile Health Intervention in the Maternal Care Pathway: Protocol for the Impact Evaluation of hAPPyMamma

Background: Mobile health (mHealth) has great potential to both improve the quality and efficiency of care and increase health literacy and empowerment of patient users. There are several studies related to the introduction of mHealth tools for supporting pregnancy and the postnatal period, with promising but not yet rigorously evaluated impacts. This article presents the protocol for evaluating an mHealth intervention (hAPPyMamma) applied in the maternal and child care pathway of a high-income country (in a pilot area of Tuscany Region, Italy). Objective: The protocol describes hAPPyMamma and the methods for evaluating its impact, including the points of view of women and practitioners. The research hypothesis is that the use of hAPPyMamma will facilitate a more appropriate use of available services, a better care experience for women, and an improvement in the maternal competencies of the women using the app compared to the control group. The protocol also includes analysis of the organizational impact of the introduction of hAPPyMamma in the maternal pathway. Methods: A pre-post quasiexperimental design with a control group is used to undertake difference-in-differences analysis for assessing the impact of the mHealth intervention from the mothers' points of view. The outcome measures are improvement of maternal health literacy and empowerment as well as experience in the maternal care pathway of the control and intervention groups of sampled mothers. The organizational impact is evaluated through a quantitative and qualitative survey addressing professionals and managers of the maternal care pathway involved in the intervention. Results: Following study recruitment, 177 women were enrolled in the control group and 150 in the intervention group, with a participation rate of 97%-98%. The response rate was higher in the control group than in the intervention group (96% vs 67%), though the intervention group had less respondent loss at the postintervention survey (10% compared to 33% of the control group). Data collection from the women was completed in April 2018, while that from professionals and managers is underway. Conclusions: The study helps consolidate evidence of the utility of mHealth interventions for maternal and child care in developed countries. This paper presents a protocol for analyzing the potential role of hAPPyMamma as an effective mHealth tool for improving the maternal care pathway at individual and organizational levels and consequently helps to understand whether and how to scale up this intervention, with local, national, and international scopes of application.