Measuring the Impact of a Mobile Health System to Support Healthy Pregnancies and Improve Newborn Survival (mCARE-II)
Primary Purpose
High Perinatal Mortality, High Neonatal Mortality, Low Antenatal Care Service Utilization
Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
mCARE-II
Sponsored by
About this trial
This is an interventional health services research trial for High Perinatal Mortality focused on measuring Community Health Workers, mHealth, mobile phones, ANC, PNC, essential newborn care
Eligibility Criteria
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
Sites / Locations
- JiVitA: Maternal and Child & Nutrition Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
mCARE-II
Comparison
Arm Description
mCARE-II supported service provision through existing community health workforce.
Standard of care, paper-based service provision through existing community health workforce.
Outcomes
Primary Outcome Measures
Decrease in Neonatal Mortality
Decrease in perinatal mortality
Secondary Outcome Measures
Increase in postnatal care utilization
Increase in essential newborn care utilization
Increase in antenatal care utilization
Increase in skilled birth attendance
Increase in immediate breastfeeding
Increase in facility-based delivery
Increase in skilled birth attendance
Full Information
NCT ID
NCT02909179
First Posted
September 19, 2016
Last Updated
July 13, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
mPower Social Enterprises Limited, The JiVitA Project
1. Study Identification
Unique Protocol Identification Number
NCT02909179
Brief Title
Measuring the Impact of a Mobile Health System to Support Healthy Pregnancies and Improve Newborn Survival
Acronym
mCARE-II
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 22, 2020 (Actual)
Study Completion Date
December 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
mPower Social Enterprises Limited, The JiVitA Project
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Perinatal Mortality, High Neonatal Mortality, Low Antenatal Care Service Utilization, Low Postnatal Care Service Utilization
Keywords
Community Health Workers, mHealth, mobile phones, ANC, PNC, essential newborn care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113539 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mCARE-II
Arm Type
Experimental
Arm Description
mCARE-II supported service provision through existing community health workforce.
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
Standard of care, paper-based service provision through existing community health workforce.
Intervention Type
Other
Intervention Name(s)
mCARE-II
Intervention Description
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 Outcome Measure Information:
Title
Decrease in Neonatal Mortality
Time Frame
Within 43 days after birth
Title
Decrease in perinatal mortality
Time Frame
22 Weeks Gestation through the first 7 days after birth
Secondary Outcome Measure Information:
Title
Increase in postnatal care utilization
Time Frame
Within 7 days of delivery/child birth
Title
Increase in essential newborn care utilization
Time Frame
Within 7 days of delivery/child birth
Title
Increase in antenatal care utilization
Time Frame
up to 34 weeks of pregnancy
Title
Increase in skilled birth attendance
Time Frame
During child birth
Title
Increase in immediate breastfeeding
Time Frame
Within first hour of life
Title
Increase in facility-based delivery
Time Frame
At time of delivery
Title
Increase in skilled birth attendance
Time Frame
At time of delivery
10. Eligibility
Sex
All
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
JiVitA: Maternal and Child & Nutrition Research Site
City
Gaibandha
ZIP/Postal Code
5700
Country
Bangladesh
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15767001
Citation
Darmstadt GL, Bhutta ZA, Cousens S, Adam T, Walker N, de Bernis L; Lancet Neonatal Survival Steering Team. Evidence-based, cost-effective interventions: how many newborn babies can we save? Lancet. 2005 Mar 12-18;365(9463):977-88. doi: 10.1016/S0140-6736(05)71088-6.
Results Reference
background
PubMed Identifier
21094420
Citation
Schiffman J, Darmstadt GL, Agarwal S, Baqui AH. Community-based intervention packages for improving perinatal health in developing countries: a review of the evidence. Semin Perinatol. 2010 Dec;34(6):462-76. doi: 10.1053/j.semperi.2010.09.008.
Results Reference
background
PubMed Identifier
12853204
Citation
Jones G, Steketee RW, Black RE, Bhutta ZA, Morris SS; Bellagio Child Survival Study Group. How many child deaths can we prevent this year? Lancet. 2003 Jul 5;362(9377):65-71. doi: 10.1016/S0140-6736(03)13811-1.
Results Reference
background
PubMed Identifier
23949837
Citation
Baqui AH, Rosen HE, Lee AC, Applegate JA, El Arifeen S, Rahman SM, Begum N, Shah R, Darmstadt GL, Black RE. Preterm birth and neonatal mortality in a rural Bangladeshi cohort: implications for health programs. J Perinatol. 2013 Dec;33(12):977-81. doi: 10.1038/jp.2013.91. Epub 2013 Aug 15.
Results Reference
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PubMed Identifier
25014008
Citation
Jo Y, Labrique AB, Lefevre AE, Mehl G, Pfaff T, Walker N, Friberg IK. Using the lives saved tool (LiST) to model mHealth impact on neonatal survival in resource-limited settings. PLoS One. 2014 Jul 11;9(7):e102224. doi: 10.1371/journal.pone.0102224. eCollection 2014. Erratum In: PLoS One. 2014;9(8):e106980.
Results Reference
background
Citation
G Mehl, L Vasudevan, L Gonsalves, M Berg, T Seimon, M Temmerman, AB Labrique. Harnessing mHealth in low-resource settings to achieve universal access to health. In: Marsch LA, Lord SE, Dallery J, editors. Transforming Behavioral Health Care with Technology: The State of the Science. Oxford University Press; 2014
Results Reference
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PubMed Identifier
25276529
Citation
Labrique AB, Vasudevan L, Kochi E, Fabricant R, Mehl G. mHealth innovations as health system strengthening tools: 12 common applications and a visual framework. Glob Health Sci Pract. 2013 Aug 6;1(2):160-71. doi: 10.9745/GHSP-D-13-00031. eCollection 2013 Aug.
Results Reference
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PubMed Identifier
22805598
Citation
Lund S, Hemed M, Nielsen BB, Said A, Said K, Makungu MH, Rasch V. Mobile phones as a health communication tool to improve skilled attendance at delivery in Zanzibar: a cluster-randomised controlled trial. BJOG. 2012 Sep;119(10):1256-64. doi: 10.1111/j.1471-0528.2012.03413.x. Epub 2012 Jul 17.
Results Reference
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PubMed Identifier
25720457
Citation
Tran MC, Labrique AB, Mehra S, Ali H, Shaikh S, Mitra M, Christian P, West K Jr. Analyzing the mobile "digital divide": changing determinants of household phone ownership over time in rural bangladesh. JMIR Mhealth Uhealth. 2015 Feb 25;3(1):e24. doi: 10.2196/mhealth.3663.
Results Reference
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Measuring the Impact of a Mobile Health System to Support Healthy Pregnancies and Improve Newborn Survival
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