Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and/or Diabetes (MOM-HD)

This is a Mobile-based Obstetric Monitoring for Hypertension and/or Diabetes (MOM-HD)2 program, which includes a patient-facing mobile app for uploading BP/BG data, a provider-facing web portal for viewing patient data, and biweekly tele-visits with a study nurse.

This study aims to utilize an implementation science framework to implement and comprehensively evaluate a mobile app-based perinatal telemonitoring program within real-world clinical settings. Collaborating with government and hospital stakeholders, the investigators will employ a theory-informed multi-faceted implementation strategies: (a) Train patients and family members, and provide continuous technical support (via mobile app) for at-home BP and/or BG monitoring; (b) Provide financial assistance for at-home BP and/or BG monitoring; (c) Technical assistance, audit, and feedback to the providers; and (d) Institutionalizing and sustaining the program through advisory boards at each hospital.

Study Objective and Aims

Primary Goal:

To conduct a hybrid type II effectiveness-implementation randomized controlled trial (RCT) to evaluate the impact of MOM-HD on clinical outcomes and assess its implementation in real-world settings in Nepal.

Specific aims:

* Aim 1: Assess the effectiveness of MOM-HD + standard care compared to standard care alone via a multi-center randomized controlled trial. * Aim 2: Assess implementation outcomes of the MOM-HD using the RE-AIM framework at the patient, provider, and health system levels. * Aim 3: Conduct a comprehensive costing analysis and economic evaluation of the MOM-HD.

Study Design

This is a type II hybrid effectiveness-implementation study conducted as a multi-site randomized controlled trial in three metropolitan hospitals in Nepal: 1) Paropakar Maternity and Women's Hospital (PMWH), 2) Dhulikhel Hospital in Dhulikhel, and 3)Nobel Medical College \& Teaching Hospital in Biratnagar.

The MOM-HD telemonitoring program will consist of patient education/ training, provision of a BP monitor and/or glucometer and strips, a mobile app where BP/BG data can be uploaded, a provider-facing web portal for monitoring patient data, as well as biweekly tele-visits with a study nurse. Participants with HDP and/or GDM in the intervention group will be enrolled in the MOM-HD program from enrollment to 6 weeks postpartum.

Overall, this study aims to evaluate the effectiveness and implementation of the MOM-HD intervention, while providing insights into the costs associated with implementing the intervention in a real-world setting.

Study Duration

The study is expected to last up to 5 years. Participants will be followed from 24-30 weeks' gestation until 6 weeks postpartum.

Sample Size

A total of 864 participants (432 with HDP and 432 with GDM).

Randomization

Participants will be randomized in a 1:1 ratio to either the intervention group (MOM-HD plus standard care) or the control group (standard care alone).

Participants with both hypertensive disorders of pregnancy (HDP) and gestational diabetes mellitus (GDM) present at enrollment will be assigned to the GDM stratum for randomization and analysis. Participants who develop a second qualifying condition after enrollment will remain in their originally assigned stratum in accordance with the intention-to-treat principle. However, they will receive all applicable intervention components corresponding to their clinical diagnoses (e.g., provision of a glucometer and blood glucose monitoring for participants who develop incident GDM after enrollment). Primary analyses will be conducted according to the original stratum assignment. Sensitivity analyses will additionally evaluate outcomes among participants with dual diagnoses.

Pregnant women who meet all diagnostic and eligibility criteria but are identified at greater than 34 weeks of gestational age will not be enrolled in the RCT and will not be considered IRB study participants. However, consistent with the program's implementation objectives, these individuals will receive the intervention components and will be tracked for implementation purpose.

Study Population: See section Eligibility

Measurements

* Primary and Secondary Outcomes: See section Outcome Measures * Implementation Outcomes: Using the RE-AIM framework (4), the study will assess Reach (e.g., proportion and characteristics of participants engaged), Adoption (provider uptake), Implementation (fidelity, facilitators, barriers), and Maintenance (sustainability and costs).

Intervention: See section Arms and Interventions

Research Method: Mixed-method and Randomized Clinical Trial

• Mean diastolic BP from recruitment to delivery (continuous) [Срок оценки: Post-treatment (at delivery)]
• Mean diastolic BP at 6 week postpartum (continuous) [Срок оценки: Post-treatment (6 weeks postpartum)]
• Mean fasting BG levels from recruitment to delivery (continuous; only among women with GDM) [Срок оценки: Post-treatment (at delivery)]
• Mean postprandial BG levels from recruitment to delivery (continuous; only among women with GDM) [Срок оценки: Post-treatment (at delivery)]
• Perinatal loss (present/ absent) [Срок оценки: Post-treatment (at delivery)]
• Neonatal intensive care unit admission (present/absent) [Срок оценки: Post-treatment (at delivery)]
• Primary cesarean delivery (present/absent) [Срок оценки: Post-treatment (at delivery)]
• Labor induction (present/ absent) [Срок оценки: Post-treatment (at delivery)]
• Need for medication ( present/ absent) [Срок оценки: Post-treatment (at delivery)]
• Pre-term birth ( present/ absent) [Срок оценки: Post-treatment (at delivery)]
• Hospital admissions ( present/ absent) [Срок оценки: Post-treatment (at delivery)]
• Mean systolic BP at 6 week postpartum [Срок оценки: Post-treatment (6 weeks postpartum)]