## Protocol Section
### Identification Module
**NCT ID:** NCT02909179

**Acronym:** mCARE-II

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

**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

#### Organization Study ID Info
**ID:** IRB00006469
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins Bloomberg School of Public Health
### Status Module
#### Completion Date
**Date:** 2020-12-22

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-17

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-12-22

**Type:** ACTUAL

#### Start Date
**Date:** 2016-06

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2016-09-21
**Type:** ESTIMATED
**Study First Submit Date:** 2016-09-19
**Study First Submit QC Date:** 2016-09-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** mPower Social Enterprises Limited

**Class:** UNKNOWN

**Name:** The JiVitA Project

#### Lead Sponsor

**Class:** OTHER

**Name:** Johns Hopkins Bloomberg School of Public Health

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**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

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 113539

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** mCARE-II supported service provision through existing community health workforce.

**Intervention Names:**

- Other: mCARE-II

**Label:** mCARE-II

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Standard of care, paper-based service provision through existing community health workforce.

**Label:** Comparison

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- mCARE-II

**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.

**Name:** mCARE-II

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Decrease in Neonatal Mortality

**Time Frame:** Within 43 days after birth

**Measure:** Decrease in perinatal mortality

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

#### Secondary Outcomes

**Measure:** Increase in postnatal care utilization

**Time Frame:** Within 7 days of delivery/child birth

**Measure:** Increase in essential newborn care utilization

**Time Frame:** Within 7 days of delivery/child birth

**Measure:** Increase in antenatal care utilization

**Time Frame:** up to 34 weeks of pregnancy

**Measure:** Increase in skilled birth attendance

**Time Frame:** During child birth

**Measure:** Increase in immediate breastfeeding

**Time Frame:** Within first hour of life

**Measure:** Increase in facility-based delivery

**Time Frame:** At time of delivery

**Measure:** Increase in skilled birth attendance

**Time Frame:** At time of delivery

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gaibandha

**Country:** Bangladesh

**Facility:** JiVitA: Maternal and Child & Nutrition Research Site

**Zip:** 5700

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 15767001

**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.

**PMID:** 21094420

**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.

**PMID:** 12853204

**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.

**PMID:** 23949837

**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.

**PMID:** 25014008

**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

**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.

**PMID:** 25276529

**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.

**PMID:** 22805598

**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.

**PMID:** 25720457

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000003643

- Term: Death

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M30666

- Name: Perinatal Death

- Relevance: HIGH

- As Found: Perinatal Mortality

- ID: M6845

- Name: Death

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000066087

- Term: Perinatal Death

### Misc Info Module

- Version Holder: 2024-05-24
