Participant evaluation of MOMitor™—a smartphone-based application that monitors postpartum mental and physical health status

Introduction

Monitoring health status and the symptoms experienced by postpartum women, especially those who had a cesarean-section (C-section) or with a history of mood disorders, hypertension, or diabetes, is crucial for reducing maternal morbidity and mortality. However, the close monitoring of postpartum mood is challenging due to the following reasons, such as limited frequency of follow-up visits, inadequate screening and assessment, and limited access to care by women due to distance, insurance status, transportation, or women’s lack of childcare (1,2). Additionally, there may be a stigma associated with postpartum depression or other complications, leading women to underreport their symptoms or avoid seeking help (3). This can make it difficult for clinicians to monitor and address these issues effectively. The current postpartum follow-up schedule recommended by the American College of Obstetricians and Gynecologists (ACOG) includes one visit within the first 3 weeks of delivery and another within 6 weeks postpartum, which may be inadequate to closely monitor women with a history of depression, anxiety, or other physical health conditions. Ecological momentary assessment (EMA) methodology, such as that deployed by the app, could address potential insufficient communication between patients and their physicians or care team members because it allows for real-time, in-the-moment monitoring and assessment of the patient’s health status and symptoms during the riskiest period of early postpartum (4-6). Mobile devices such as smartphones also allow participants to conveniently report on their symptoms and health status at various points throughout the day, providing a more nuanced and comprehensive view of a participant’s postpartum mental and physical health status (7).

Rigorous evaluation of user experience is crucial for optimization of digital health technologies, such as the MOMitor^TM app, because it allows the developers to be responsive to the needs of postpartum women and their treating clinicians (8,9). By gathering insights on the app’s features, interface, and overall impact on postpartum care from end users, we can identify areas for improvement and prioritize updates that enhance the app’s performance with the ultimate goal of improving postpartum care quality and reducing maternal morbidity and mortality.

MOMitor™ is a mobile phone-based application that utilizes EMA methodology to assess real-time mood symptoms, infection symptom monitoring following C-section, hypertension, and diabetes among postpartum women. EMA methods use repeated collection of real-time data in subjects’ real-world environments (7). MOMitor™ assesses participant-reported symptoms on a predetermined basis and sends alerts to clinic staff if the responses cross a certain pre-determined threshold. When responses cross the threshold, an alert is triggered to the study team, whereby a study team nurse calls the participant for further evaluation and clinical action as necessary, including referrals, medication adjustments, appointment scheduling, and emergency interventions such as hospitalization. The objective of this study, therefore, is to evaluate exit surveys from all MOMitor™ study participants at the end of the 6-week postpartum intervention period during the app’s 1-year beta testing phase. This multi-method evaluation, consisting of both multiple-choice and open-ended questions that provided opportunities for in-depth feedback, specifically aimed to examine user (postpartum women’s) experience with the application for each of the following areas: satisfaction with the app’s user (postpartum women’s) experience, perceived benefits of the app, and the challenges faced by women while using the app.

Methods

Sample

We enrolled a total of 535 women who were 18 years or older, delivered a viable live-born infant, were fluent in English, used a smartphone, were willing to download and use the MOMitor™ application, and respond to assessments for 6 weeks postpartum during the study period, which occurred from October 2021 to June 2022. All participants provided signed informed consent before their enrollment into the study. This study was approved by the University of Florida Institutional Review Board (UF-IRB No. 202101618), and was conducted in accordance with the Declaration of Helsinki and its subsequent amendments.

Recruitment

The study setting was in a single health-system in the southern United States. All obstetrics clinicians in this large, academic-affiliated health-system were informed of this new initiative and were asked to share information about MOMitor™ with their patients in the clinical setting and/or during their hospitalization through the labor and delivery and postpartum units. Clinicians were educated about the purpose and utility of the app. They were given examples of the medical condition algorithms and advised that nursing staff would be notified with responses that exceeded the expected thresholds. Clinicians were also advised that they would be notified by the research nurse when intervention was necessary.

Study research coordinators met with all women in the postpartum unit of UF Health Shands Hospital before discharge, explained the study in detail, and assessed eligibility criteria for participation in this study. All women delivering live births in the health-systems hospital and meeting eligibility criteria were offered the opportunity to participate.

Women were recruited for the study during their hospital stay for the delivery of their infant. For those without major complications, the typical hospital stay in this health-system is less than 48 hours. For those with complications, the hospital stay for delivery may be longer, but efforts were made to conduct recruitment of those women during the hospital stay within 48 hours after giving birth. Women who consented to participate in the study received an incentive of $15 after enrollment and $15 at the study’s conclusion. Once consented and enrolled, participants were assisted in downloading the free mobile phone application—MOMitor™ and then trained in all the functionalities such as accessing the daily assessments, how to respond and submit the assessments by the research staff who has been part of the app development from the beginning and hence well versed in the application features and functionalities. Participants completed a baseline assessment that included socio-demographic information and current physical and mental health status before their discharge from the hospital. All participants who were at risk for preeclampsia or had a history of hypertension were provided with a blood pressure cuff to take home with them. Participants with type I or type II diabetes were offered blood glucose test strips.

Intervention

The intervention duration was 6 weeks postpartum starting from the date of delivery hospitalization discharge. Depending on their risks following delivery, participants were notified through the app to answer questions about their physical and/or mental health symptoms at a predetermined frequency. The MOMitor™ application was supported by Ilumivu to deliver notifications and transmit collected data between the participant’s smartphone app and the study team. Ilumivu is a Digital Therapeutics company enabling personalized patient care outcomes through proactive interventions using the psychology of behavior change. The Ilumivu platform combined with mobile EMA (mEMA) is a robust, patient-centered software platform designed to capture rich, multimodal behavioral data streams through user engagement. This application is Health Insurance Portability and Accountability Act (HIPAA) compliant, and the application can be tailored and personalized based on the participant’s needs regarding the timing of alerts. All enrolled participants received mood questions, while the hypertension, diabetes, and C-section questions were sent only to those women who had histories of or risks for developing those conditions. Participants were provided with blood pressure cuffs and/ or blood glucose test strips if they had a history of hypertension or diabetes, respectively, and did not have these items already. Further, participants were trained how to use the blood pressure cuffs and the blood glucose test strips during recruitment by our staff as part of the enrollment orientation, as applicable.

Four different types of branching systems were utilized for the assessment algorithm of women enrolled in each of the conditions. The measures used were the Edinburgh Postpartum Depression Scale (EPDS) for mood assessment and the Generalized Anxiety Disorder (GAD) for anxiety assessment. The blood pressure, gestational diabetes, and C-section wound healing and wellness were assessed using questions developed specifically for this study. The assessment frequencies were determined based on the clinical expertise of our team and literature. The EPDS questionnaire to assess mood had 10 questions, the hypertension survey had two questions, the gestational diabetes survey had two questions, and the C-section survey had two questions. Each survey took less than 5 minutes to complete. Women who were enrolled in the C-section group also had the opportunity to upload the picture of their C-section wound when requested. All women received a question assessing their mood daily in the first 2 weeks, such as “Overall how are you feeling today?”. Depending on their response (happy or sad), they may or may not receive a EPDS for further evaluation. After the first 2 weeks, mood assessment questions are spaced to once per 2 weeks. Women who had a cesarean delivery (C-section) will receive an additional question a day that assesses the healing of their incision. They will be asked to send a picture of their incision for the nurse/clinician to examine. Women who are at risk for diabetes will receive an additional question regarding their blood glucose readings every day. Based on the readings, they will either be encouraged to continue as usual, or they will receive a call from the nurse for assistance in managing their blood glucose level. Women who are at a risk of preeclampsia will receive an additional question daily on their blood pressure readings.

Questions were asked at a pre-determined time and day of the week, and each question appeared up to three times for 1 hour (unless answered after the 1^st or 2^nd alert) and stayed open from 8.30 am to 3 pm providing the participant adequate time to respond, after which the application will register a “no response” to that specific question. All responses from the participants were date and time-stamped. All questions were either multiple choice or as a scale that can be responded to by a single swipe. More than three consecutive “no response” statuses to any question flagged the study team regarding participant unresponsiveness. Flagged participants were then contacted via phone by the study staff to encourage participation in cases of non-responsiveness, and this contact was used to provide resolution for issues such as technical support, if applicable. If the staff was unable to contact them after three attempts of calls or leaving a voice message, they were classified as lost to follow up. However, they still received the final participant evaluation exit survey. Any nurse interaction with a participant was documented in the patient’s electronic medical records (EMR). Furthermore, when an intervention was required (medication change, need for follow-up visit, recommendation for emergency evaluation or hospitalization), the research nurse document in the EMR and directly notify the clinician. If a participant screens positive to any question regarding symptoms indicating possible C-section site infection (i.e., redness, pus, fever, pain), we request them to upload the picture of the incision site. The nursing team receives the picture and reviews. The nursing team contacts the participant directly for further questioning or follow-up care, or the nursing team consults a physician (or the patient’s primary care clinician), to give notice and request follow-up guidance.

Participant evaluation exit survey

All enrolled participants were administered a participation evaluation exit survey, crafted by the research team to assess the usability and acceptability of MOMitor™ features and functionalities at the conclusion of their 6-week study period, regardless of whether they completed all assessments, unless the participant opted to withdraw from the study. The survey invitations were delivered via email, and email reminders were sent twice, at 2-week intervals. The exit survey comprised 15 multiple-choice questions and six open-ended questions to ensure ample opportunities to collect targeted feedback on each of the areas of interest [i.e., user (postpartum women’s) experience, utility, and recommendations for changes]. Survey data were collected electronically via research electronic data capture (REDCap) (10,11), which is a secure web application for building and managing online surveys and databases, where data can be entered directly from participants using a smartphone or computer/tablet via the invitation link send to them using their emails.

Statistical analysis

Quantitative data

We reported the following participant characteristics collected at baseline: age, race, gestational age of the infant at delivery, number of pregnancies, number of living children, and delivery method. Further, we examined the ‘rate of compliance with the app assessments’ and the ‘usefulness of the app’ concerning each of the groups: (I) all participants (since all participants received the mood assessments); (II) those who were assigned to the hypertension group; (III) those who were assigned to the C-section group; and (IV) those who were assigned to the diabetes group. We conducted Chi-squared and Fisher’s exact tests as appropriate to assess the association between the monitored conditions and compliance or usefulness of the app. SAS version 9.4 (SAS Institute) (12) was used to analyze demographic information.

Qualitative data

We conducted a content analysis of participant’s open-ended responses via manual coding to identify the most frequently reported themes under satisfaction and challenges with the app. We used a deductive content analysis approach for analysis. Two coders independently coded the focus group transcripts meeting weekly to compare the codes and reach a consensus. During the second cycle of coding, codes that reflected a pattern or were similar in meaning were collated into themes that answered the research questions. This paper presents the results from the two themes: ’satisfaction/benefits’ and ‘challenges’.

Results

A total of 535 participants were enrolled in the MOMitor™, and 483 participants received the exit evaluation survey at the end of the 6-week period. Among the 483 participants who received the exit survey, 52 requested study withdrawal (n=431), and 213 participants responded. This gave us a response rate of 49.4%. To evaluate the compliance with app assessments and the usefulness of the MOMitor™ application, the first question, “Did you open the MOMitor™ application at least once?” was required to be answered. A total of 192 participants answered ‘yes’ to this question. One hundred and ninety out of 213 participants (89.2%) who responded to at least one question in the evaluation survey reported that they opened the MOMitor™ application at least once. Given the small sample size of respondents in the diabetes group (six women), we excluded that group from sub-group analysis. Therefore, the final sample size for this analysis was 190, 69, and 77 for mood, hypertension, and C-section, respectively.

Demographic characteristics

The mean age of the women was 30.6 [standard deviation (SD), 5.8] overall, and 30.7 (SD, 6.4) for the hypertension intervention group, and 31.1 (SD, 5.7) for the c-section intervention group. The gestational age of the infant at delivery was also similar across the three groups, i.e., 38.5 (SD, 2.6), 37.5 (SD, 3.1), and 37.8 (SD, 2.9). The mean number of pregnancies ranged from 2.6 to 3.0. More than half (64.2%) of our total participants were Caucasians followed by African Americans (19.5%) and then those who identified as ‘other races’ (16.3%). A similar distribution of race was also seen in the hypertension and C-section groups. More than half of the participants were in the age group of 26–35 years. Approximately, 55.8%, 71.0%, and 71.1% of women in the mood, hypertension, and C-section groups, respectively, delivered a baby with the pre/early gestational age, were the gestational age is under 39 weeks, based on the Centers for Disease Control and Prevention (CDC) definition (more details in Table 1).

Participant evaluation survey

Usage

Table 2 shows the findings from the participant evaluation survey from all 190 respondents who opened the app at least once. Among 187 who responded to the question whether they received any notifications, approximately 91.4% (n=171) of participants said ‘yes’ to receiving a notification through the app at least once. Only 3.0% reported that they changed the default setting of the MOMitor™ application. Among all the participants, 46.9% reported being contacted by a nurse and 21.9% of the total 190 participants mentioned that they discussed the app with their clinicians.

Adherence

Out of 169 participants who responded to the question on adherence to the MOMitor™ application, 42.6% and 41.4% reported responding every time or most of the time, respectively, to the app assessments (Table 3). While 13.0% mentioned responding sometimes and 2.4% reported responding rarely. Only one participant stated that she never responded to any assessments or notifications from the app. Only 6.0% and 2.4% of the 169 women mentioned that they contacted the study nurse most of the time or sometimes, while 9.6% said rarely and the majority (81.9%) said that they never contacted the study nurse.

All participants received the mood survey and only 166 participants responded to the question regarding recording their mood in the evaluation survey. Three-fourths of the participants mentioned that they recorded their mood most of the time, and only 4.8% noted that they never recorded their mood. Overall, 64 out of the 69 participants in the hypertension group and 69 out of 77 in the C-section group responded to the questions regarding adherence to the MOMitor™ app. About 70% of the hypertension group stated that they recorded their blood pressure most of the time and a quarter mentioned that they recorded it sometimes. Only 2–3% mentioned that they rarely or never recorded their blood pressure despite being in the hypertension group. About 60% of the participants recorded the updates regarding their healing every time, while two-tenths recorded them sometimes. Only 4–12% reported recording their healing rarely or never. Participants with hypertension are more likely to record their blood pressure frequently (70.3%) compared to patients without hypertension (3.9%) (Table 1, Table S1). Similarly, participants with hypertension found the educational feature (37.3%) very helpful than their counterparts (Table 2, Table S2).

Usefulness

The last section of the participant survey was on the usefulness of the MOMitor™ application. Overall, 149 to 160 participants responded to the various questions in this category (Table 4). More than one-third of the participants reported all features as very helpful except for uploading the picture (18.0%). Among all, ‘recording the mood’ was reported as the ‘most helpful’ feature of all. More than 40% of the participants reported this feature as either helpful or very helpful. Two features that were reported to helpful by many participants were message notifications (37.8%) and contact with the nurse (39.4%).

Among all participants, women in the hypertension and C-section groups were more likely to record responses to various assessments including their blood pressure readings and C-section wound healing questions. Additionally, women with hypertension were more likely to indicate the notification (P=0.02) and educational information (P=0.02) in the app as ‘helpful’ or ‘very helpful’ than women in other groups. Sub-group analyses were limited as we did not have enough sample size for some of the interventions (notably diabetes) to compare key experiences of app usage and perceived feasibility/utility, suggesting need for further research in this area.

Qualitative analysis

The analysis of the responses from the open-ended questions in the survey was aimed at getting an in-depth understanding of the benefits and challenges of using the MOMitor™ application directly from the women. Table 5 presents the benefits and challenges most frequently reported by the MOMitor™ app users (postpartum women).

Benefits

The most frequently reported benefits of the MOMitor™ app were its ability to assist them in monitoring their symptoms and reaching out to a clinician to seek help when needed. Several women also mentioned that they thought the notifications feature of the app was beneficial to them to remember the tasks that they needed to complete. Another frequently reported benefit was convenience. Women felt that the app was simple, easy to use, and was with them all the time since it was on their phones.

Challenges

The most frequently reported challenges by the participants were an unfriendly interface, an inadequate timeframe to respond to questions, the need to download updates regularly, a requirement that the app needs to be kept open in the background always, and the visually unappealing app design. Several women found the user interface inconvenient and the menus difficult to navigate. Some others noted that the time frame to respond to a question was inadequate. Two other commonly reported challenges were that the MOMitor™ app needed to be kept open in the background for them to receive the assessments and other notifications regularly. Many women logged out after responding to a question and missed receiving other questions initially. A few women also mentioned that the appearance of the MOMitor™ app is not ‘eye-catching’ and needs improvement. Table 3 gives the verbatim quotes from the respondents regarding the benefits and challenges of the MOMitor™ app.

Discussion

This study presents the findings of a participant evaluation survey of a mobile phone-based application MOMitor™ app developed by this team to monitor and assess postpartum mood and other health conditions, specifically, hypertension, diabetes, and C-section incision site infection. Though only 40% of the total participants responded to the evaluation survey, the findings presented here provide us a clear picture of the app features that were useful and convenient and those that need improvement. Our response rate of 49.4% is higher than a recent study that reported 46% response rate for web-based surveys and closer to the email surveys by patients (51%) in the same study (13).

A large majority (84%) mentioned that they responded to the app ‘most of the time’ or ‘every time’, indicating a high adherence rate and the app’s usefulness for those who utilized it. Among the 190 participants who mentioned using their app at least once, 91% reported receiving notifications. It was unclear why the rest (9%) did not receive any notifications. Half of the participants mentioned contacting the nurse either because their responses did not trigger any alerts, or because they completed all assigned surveys within the allocated period. Similarly, nearly three-fourths of participants recorded their mood and blood pressure, and 62% of those who had a C-section recorded their healing process, again reflecting the app’s utility for the assessment group. Consistent with this finding, the qualitative data also highlighted that woman considered ’self-monitoring of symptoms’ by responding to the assessment questions periodically as an important benefit of using the MOMitor™ application (Table 3). A recent pilot study that collected daily mood, sleep, and activity data on postpartum women for 6 weeks using EMA also reported a compliance rate of 67% (34.4/51.5 days) of all active daily assessments and 74% (38/51.5 days) of all passive measures (5). The higher engagement rate with the app in this study could be due to its personalized approach rather than sending general informational messages to all participants.

The results of this survey not only confirm the app’s current settings as optimal but also provide valuable insights into the app’s overall utility and user experience. 97% of respondents reported leaving the app settings unchanged, suggesting that the existing configuration is well-suited to meet the needs of its users or most app users do not have the time or are unaware to change the settings. This could also be because the app’s current settings are capable of providing a user-friendly and intuitive experience. The qualitative responses further emphasize the app’s value in supporting women during the postpartum period. The MOMitor™ app was consistently rated as ‘helpful’ or ‘very helpful’ by our women, highlighting its overall usefulness and potential to improve postpartum care.

The features most frequently cited as ‘helpful’ or ‘very helpful’ were ‘contact the nurse’ and ‘record your mood’, underscoring the importance of postpartum mood assessments and the need for ongoing clinical support. Regularly responding to questions via the app also had a significant impact on women, with many reporting that it made them feel as though ’someone cared’. Postpartum women may feel lost, be confined to their homes most of the time, and may feel unsupported by their family and friends (14,15). This could be the reason that those who used our MOMitor™ app felt supported and cared for by a professional who is easy to reach and communicate with in case of any concerns, especially during the coronavirus disease 2019 (COVID-19) pandemic, when the feelings of isolation were reported at a higher degree (14).

Further, contrary to the ongoing debate on asking new mothers to answer periodic assessments as burdensome, women’s responses such as ‘Convenient because I can log things right on my phone’ or ‘It was simple to check if you are unwell and get help’ highlights the acceptance of ‘real-time’ logging of their symptoms and getting responses from the clinical staff (16,17). As in this study, several other studies have also reported many women logging newborn habits like breastfeeding or diaper changes in apps on their phones during the newborn days (18). Responses from this feasibility study show that women are willing and happy to log their symptoms in real-time to communicate any concerns with clinicians. Previous studies have shown that many women despite their symptoms such as sadness, hopelessness, fatigue, and feeling overwhelmed and unable to carry out their tasks as new mothers do not report their symptoms. This could be due to a lack of awareness or shame in sharing feelings of sadness at a time when society expects you to be happy. An app such as MOMitor™ could provide women a convenient way to make themselves aware of their symptoms by responding to daily questions as well as provide them with a private and confidential channel to communicate their symptoms with their clinicians and seek help. Women in this study also mentioned periodic notifications that remind them to answer the assessments as a benefit. As in these studies, participants from several other previous EMA studies have also reported the convenience of being able to respond via their mobile phone which is always with them (19).

The ‘upload a photo’ feature was exclusively available to the C-section group and ‘record your BP’ was also only available to those who were in the blood pressure group. As a result, participants in other groups might not have understood the exact nature of this feature, which could explain the high rate of ‘not helpful’ responses to these two questions.

Four out of five challenges highlighted by our participants were related to the design of the MOMitor™ app itself. Several women reported dissatisfaction with the short response time. This is understandable considering the multitude of duties required of a postpartum woman. Therefore, it is justifiable that the women indicated the need for extra time to complete the responses. As in previous studies, women in this study also reported that it was difficult to download periodic app updates (4,20). Though we agree with that concern, installing periodic updates is necessary for the optimal functioning of any mobile application. Another challenge that women encountered was the automatic shutdown of the application if it remained unused for a specific duration, failing to send notifications and messages to women. We recognize this is a significant obstacle that may hinder the application’s usefulness among a bigger user (postpartum women) base. It is crucial to explore ways to address this challenge to improve user satisfaction and minimize user burden. Another challenge women faced was that the application if left unused for a certain period shut down on its own and hence did not send the notifications to women. We acknowledge that this is an important challenge that could limit the usability of the application when used by a larger population. Further exploring ways to address this challenge to improve user satisfaction and minimize user burden is important.

The visually unappealing landing page of the app and the uninviting app interface were two additional challenges mentioned by our participants. The landing page is often the first interaction potential users have with the app. An appealing, well-designed landing page can create a positive first impression, encouraging users to download and try the app. This along with a user-friendly interface enhances the overall user experience. When users find an app intuitive and easy to navigate and inviting, they are likelier to enjoy using it and less likely to become frustrated or confused. Previous studies also reported the significance of user-friendly app interfaces for maintaining user engagement, satisfaction, and competitive edge (21-23). It also helps to build a loyal user base and can significantly impact the app’s overall success. Given limited resources, we prioritized app features to allow for customization for common postpartum complications (e.g., hypertension, C-section surgical site recovery). A next step would be to put resources into making it more visually appealing as suggested by the participants. The future plan is to conduct a larger study with participants from different counties and health care systems within the state.

Limitations

We recognize that all the participants for this feasibility study were recruited from one large hospital attached to a large public university. Hence, the results may not be generalizable at a national level without a larger multi-site study. Although, we are one of the largest studies focusing on the close-monitoring system for postpartum women, some of our findings might be inconclusive due to the diverse responses we tried to capture as well as the average responses rate. However, we still have the large sample size, more than five times than any other studies. At the same time, the mediocre responses rate could bias our findings. We also acknowledge that 10% of our participants who opened the app reported not receiving any notifications which also could have impacted the overall response rate. However, our response rate is consistent with other web-based surveys, and the characteristics of our participants are consistent between responder and non-responder. Thus, we are confident with our findings. Further, we acknowledge that those who responded to the exit survey may be different in a meaningful way than non-responders, particularly considering their perceived positive or negative experiences with the app, and this should be considered a limitation. Lastly, we need to interpret some of our findings with caution given they are based on subjective participant responses. For example, participants may have different cut-offs between the ‘very helpful’ and ‘helpful’, as well as ’sometimes’ and ‘frequently’. These variations might lead to fluctuation on some of responses. However, the findings on the less granular perspective are consistent: participants with hypertension or c-section are more likely to find the app are helpful, or very helpful.

Conclusions

Despite the limitations, this feasibility study shows that mobile phone-based apps such as MOMitor™, which utilizes EMA methodology, are acceptable for monitoring and assessing the mental and physical health of post-partum women to facilitate early intervention and treatment. Improved patient-clinician communication and the ability of the app to equip women to self-monitor their symptoms were found beneficial and acceptable for postpartum women. Despite a few suggestions for improvement, the MOMitor™ app has a high potential to serve as a simple, convenient, and acceptable tool for postpartum health monitoring and early intervention to prevent maternal morbidity and mortality.

Acknowledgments

We would like to acknowledge the Ilumivu team’s continued technical support throughout this project.

Footnote

Data Sharing Statement: Available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-6/dss

Peer Review File: Available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-6/prf

Funding: The Florida Department of Health (FL-DOH) funded this study. Funders had no role in the analysis or interpretation of the results.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-25-6/coif). D.S.V., A.J.G., and K.R.R. report that the funding for this study was from the Florida Department of Health and they participate as a member of the study Advisory Board, which is an unpaid role. T.J. reports a grant from Bill & Melinda Gates Foundation. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the University of Florida Institutional Review Board (UF-IRB No. 202101618) and informed consent was obtained from all individual participants.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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