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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official 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

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 Summary:

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 evalua
Sponsor: Johns Hopkins Bloomberg School of Public Health

Current Primary Outcome:

  • Decrease in Neonatal Mortality [ Time Frame: Within 43 days after birth ]
  • Decrease in perinatal mortality [ Time Frame: 22 Weeks Gestation through the first 7 days after birth ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Johns Hopkins Bloomberg School of Public Health

Dates:
Date Received: September 19, 2016
Date Started: June 2016
Date Completion: December 2018
Last Updated: September 20, 2016
Last Verified: September 2016