Measuring the Impact of a Mobile Health System to Support Healthy Pregnancies and Improve Newborn Survival

Not Applicable

Completed

• Conditions: High Neonatal Mortality; Low Antenatal Care Service Utilization; High Perinatal Mortality; Low Postnatal Care Service Utilization
• Interventions: Other: mCARE-II

• Registration Number: NCT02909179
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

The purpose of this community-based randomized controlled trial is to test whether the mCARE-II intervention package, delivered by the existing Government of Bangladesh community health workforce, will improve neonatal and perinatal survival in a rural setting in northwestern Bangladesh. mCARE-II is a digital health intervention, which incorporates automated workload scheduling, client prioritization and risk stratification, overdue service reminders and demand generation through client side reminder messaging. The intervention package focuses on the pregnancy and early postpartum period.

Detailed Description

The aim of this study is to implement and evaluate the mCARE-II intervention package using a randomized controlled trial design. This package, supported by an mHealth application, provides workflow scheduling for guided household registration, census, pregnancy surveillance, and antenatal, postnatal, and essential newborn care visit reminders. Workflow scheduling is sorted and prioritized based on assessment of basic risk. Furthermore, the system integrates client-directed reminder SMS messages and demand-side birth notifications to schedule postnatal services immediately after birth. This will be operated by the Government of Bangladesh (GoB) community health workers, called Family Welfare Assistants (FWAs), in 18 unions of one northern district of Bangladesh who will use the system to support their routine health service delivery functions. Based on lessons learned from phase I implementation under the pilot study, additional features will be added to the intervention package, including a priority sorting algorithm to identify pregnant women and newborns with known risk factors for adverse outcomes to prioritize them for scheduled visits, a birth preparedness module to help pregnant women and their families plan for safe delivery and childbirth, and targeted newborn care counseling during late antenatal encounters. These features will be built on a scalable platform compatible with national data systems and aligned with a new global standard being advocated by WHO - the Open Smart Register Platform or OpenSRP (smartregister.org).

Based on randomization to mCARE-II or control arms by FWA catchment area, participants living in each area will receive services from their FWA, either supported by OpenSRP or according to the standard of care procedures currently in place. Performance of the FWAs and the health status of enrolled women and newborns will be monitored and evaluated by a rigorous research layer supported by a cadre of research workers who will verify services received by participants to assess exposure to and interactions with FWAs and OpenSRP. This study combines a robust RCT methodology with principles of implementation science - actual government health workers using OpenSRP to support their routine work while a cadre of highly-trained research workers collects 'gold-standard' denominator data against which to measure performance. This study is an effort to rigorously evaluate the set of mCARE-II interventions on the OpenSRP platform.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-21
• Primary Completion: 2020-12-22
• Study Completion: 2020-12-22
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113539

Inclusion Criteria

• Married women of reproductive age living with their husbands in the JiVitA study area in Gaibandha, Bangladesh
• Consented for participation in 8 weekly pregnancy surveillance
• Self reported as being pregnant
• Infants born to eligible, enrolled women

Exclusion Criteria

• Women who are menopausal or sterilized
• Refused to participate in 8 weekly pregnancy surveillance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mCARE-II	mCARE-II	mCARE-II supported service provision through existing community health workforce.

Primary Outcome Measures

Name	Time	Method
Decrease in Neonatal Mortality	Within 43 days after birth
Decrease in perinatal mortality	22 Weeks Gestation through the first 7 days after birth

Secondary Outcome Measures

Name	Time	Method
Increase in postnatal care utilization	Within 7 days of delivery/child birth
Increase in antenatal care utilization	up to 34 weeks of pregnancy
Increase in skilled birth attendance	At time of delivery
Increase in facility-based delivery	At time of delivery
Increase in essential newborn care utilization	Within 7 days of delivery/child birth
Increase in immediate breastfeeding	Within first hour of life

Trial Locations

Locations (1)

JiVitA: Maternal and Child & Nutrition Research Site; 🇧🇩 Gaibandha, Bangladesh