High Perinatal MortalitymCARE-IINCT02909179
Measuring the Impact of a Mobile Health System to Support Healthy Pregnancies and Improve Newborn Survival
A study testing mCARE-II in people with High Perinatal Mortality and High Neonatal Mortality, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- High Perinatal Mortality, High Neonatal Mortality, Low Antenatal Care Service Utilization
- What is being tested?
- mCARE-II
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113,539 participants
- Where
- 1 siteBangladesh
- Study dates
- Jun 2016to 22 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Women who are menopausal or sterilized
- Refused to participate in 8 weekly pregnancy surveillance
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
JiVitA: Maternal and Child & Nutrition Research Site
Gaibandha, 5700
About this study
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
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.
Read the 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.
- Conditions
- High Perinatal Mortality, High Neonatal Mortality, Low Antenatal Care Service Utilization, Low Postnatal Care Service Utilization
- Being tested
- mCARE-II
- Keywords
- Community Health Workers, mHealth, mobile phones, ANC, PNC, essential newborn care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCARE-IIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| mCARE-II | Experimental | mCARE-II supported service provision through existing community health workforce. Receives: Other: mCARE-II |
| Comparison | No intervention | Standard of care, paper-based service provision through existing community health workforce. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Neonatal Mortality
Measured: Within 43 days after birth
Decrease in perinatal mortality
Measured: 22 Weeks Gestation through the first 7 days after birth
Secondary outcomes (7)
Increase in postnatal care utilization
Measured: Within 7 days of delivery/child birth
Increase in essential newborn care utilization
Measured: Within 7 days of delivery/child birth
Increase in antenatal care utilization
Measured: up to 34 weeks of pregnancy
Increase in skilled birth attendance
Measured: During child birth
Increase in immediate breastfeeding
Measured: Within first hour of life
Increase in facility-based delivery
Measured: At time of delivery
Increase in skilled birth attendance
Measured: At time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startJun 2016
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for High Perinatal MortalityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113,539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- mPower Social Enterprises Limited, The JiVitA Project
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909179
- Sponsor's protocol ID
- IRB00006469
- Acronym
- mCARE-II
- Status last verified
- Jul 2023
- First submitted
- 19 Sep 2016
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 15767001Schiffman 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.
PubMed 21094420Jones 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.
PubMed 12853204Baqui 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.
PubMed 23949837Jo 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.
PubMed 25014008G 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
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.
PubMed 25276529Lund 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.
PubMed 22805598Tran 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.
PubMed 25720457Tong H, Thorne-Lyman A, Palmer AC, Shaikh S, Ali H, Gao Y, Pasqualino MM, Wu L, Alland K, Schulze K, West KP Jr, Hossain MI, Labrique AB. Prelacteal feeding is not associated with infant size at 3 months in rural Bangladesh: a prospective cohort study. Int Breastfeed J. 2024 Feb 27;19(1):15. doi: 10.1186/s13006-024-00621-4.
PubMed 38413997
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02909179
- Acronym / sponsor ID
- mCARE-II / IRB00006469
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113,539 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- mPower Social Enterprises Limited, The JiVitA Project
- Study start
- Jun 2016 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mCARE-II | Experimental | Other: mCARE-IImCARE-II supported service provision through existing community health workforce. |
| Comparison | No intervention | –Standard of care, paper-based service provision through existing community health workforce. |
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Women who are menopausal or sterilized
- Refused to participate in 8 weekly pregnancy surveillance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mCARE-IImCARE-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. | Other | mCARE-II |
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Background: PubMed 15767001Darmstadt 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.
- Background: PubMed 21094420Schiffman 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.
- Background: PubMed 12853204Jones 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.
- Background: PubMed 23949837Baqui 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.
- Background: PubMed 25014008Jo 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.
- BackgroundG 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
- Background: PubMed 25276529Labrique 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.
- Background: PubMed 22805598Lund 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.
- Background: PubMed 25720457Tran 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.
- Derived from this study: PubMed 38413997Tong H, Thorne-Lyman A, Palmer AC, Shaikh S, Ali H, Gao Y, Pasqualino MM, Wu L, Alland K, Schulze K, West KP Jr, Hossain MI, Labrique AB. Prelacteal feeding is not associated with infant size at 3 months in rural Bangladesh: a prospective cohort study. Int Breastfeed J. 2024 Feb 27;19(1):15. doi: 10.1186/s13006-024-00621-4.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mCARE-II in people with High Perinatal Mortality and High Neonatal Mortality, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Neonatal Mortality (time frame: Within 43 days after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02909179, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.