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OpenTrials
Completed

NCT Number: NCT02909179

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

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.

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Key information

Age range

Up to 45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JiVitA: Maternal and Child & Nutrition Research Site

Gaibandha, 5700, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mCARE-II

Other

mCARE-II is a package of interventions that provides guided client enumeration and follow-up support to community health workers, automated workflow scheduling, risk assessment, client prioritization and stratification and client-based demand generation messaging. These features are incorporated into a platform called OpenSRP, which integrates text message reminders, scheduling, and form submissions on the server side, and displays schedules and client lists on a tablet-based application for community health workers.

Primary outcomes

  1. Decrease in Neonatal Mortality

    Time frame: Within 43 days after birth

  2. Decrease in perinatal mortality

    Time frame: 22 Weeks Gestation through the first 7 days after birth

Secondary outcomes

  1. Increase in postnatal care utilization

    Time frame: Within 7 days of delivery/child birth

  2. Increase in essential newborn care utilization

    Time frame: Within 7 days of delivery/child birth

  3. Increase in antenatal care utilization

    Time frame: up to 34 weeks of pregnancy

  4. Increase in skilled birth attendance

    Time frame: During child birth

  5. Increase in immediate breastfeeding

    Time frame: Within first hour of life

  6. Increase in facility-based delivery

    Time frame: At time of delivery

  7. Increase in skilled birth attendance

    Time frame: At time of delivery

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • The JiVitA Project
  • mPower Social Enterprises Limited

Registry information

Official study title

mCARE II: Enhancing, Integrating and Scaling mCARE and Measuring the Impact of a Mobile Health System to Support Healthy Pregnancies and Improve Newborn Survival

Acronym: mCARE-II

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2016
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.