- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03406221
Use of Mobile Technology by Community-Based Health Workers to Promote Maternal and Child Health in Bihar, India (ICT-CCS)
Use of Mobile Technology to Improve the Performance of Community-Based Health Workers in Promoting Reproductive, Maternal, Newborn and Child Health and Nutrition Behaviors in Bihar, India: A Cluster Randomized Trial
This study is designed to evaluate the impact of use of mobile technology by community-based health workers on health-promoting behaviors among women related to reproductive, maternal, newborn and child health and nutrition in Bihar, India.
The intervention was funded by the Bill and Melinda Gates Foundation (BMGF) and in collaboration with CARE was implemented from 2012 to 2014. Health sub-centers in the catchment areas of four blocks (sub-districts) of the district of Saharsa were randomly assigned to treatment or control arms (35 sub-centers were assigned to each). Data were collected in the Intervention and Control areas from mothers of infants 0-12 months at baseline and at 2-year follow-up, to assess the intervention's effects on quality and quantity of FLW home visits, postnatal health behaviors, and among older infants/toddlers, complementary feeding and vaccination. Difference in difference analyses were used to assess outcome effects in this quasi experimental study.
The ICT-CCS intervention was implemented in areas where the BMGF-funded Ananya program (official title: Bihar Family Health Initiative) was also being implemented. Thus, the impact is of the [ICT-CCS intervention + Ananya] versus [Ananya alone]. The Ananya program was developed and implemented via a partnership of BMGF, CARE, and the Government of Bihar. The ultimate purpose of Ananya was to reduce maternal, newborn, and child mortality; fertility; and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to build front line health worker (FLW) capacities and reach to communities and households, as well as to strengthen public health facilities and quality of care to improve maternal and neonatal care and health behaviors, and thus survival. It was implemented from 2012 to 2014. Eight focal districts in western and central Bihar received Ananya, while 30 districts did not.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mothers of infants 0-12 months residing in the catchment area of the subcenters
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Arm
|
Standard of care
|
Experimental: Intervention arm
|
Mobile phones were made available to community health workers in the intervention arms that integrated a comprehensive set of functions to assist them in their duties, including registration and tracking of beneficiaries, automated scheduling of home visits, provision of health information through videos, guided protocols for conducting home visits through checklists, a feature to track child immunizations, and supervisory tools.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Receipt of two or more home visits from an FLW in the final trimester of pregnancy and delivery at a facility (versus home birth), using maternal survey response
Time Frame: 2 year follow-up
|
Assessed via self-report from representative sample of mothers of children aged 0-11 months; item created for Ananya Survey
|
2 year follow-up
|
Receipt of any postnatal home visits from an FLW (in the first 24 hours at home after delivery and in first month following delivery), using maternal survey response
Time Frame: 2 year follow-up
|
Assessed via self-report from representative sample of mothers of children aged 0-11 months; items created for Ananya Survey.
|
2 year follow-up
|
Any complementary feeding of solid or semisolid food for infants aged 6-11 months, using maternal survey response
Time Frame: 2 year follow-up
|
A survey item was used to assess complementary feeding of infants as reported by mothers of infants aged 0-11 months; items created for Ananya Survey.
|
2 year follow-up
|
Immunizations
Time Frame: 2 year follow-up
|
Receipt of DBT1 and DBT3 for infants 6-11 mo; receipt of DPT3 and measles vaccine for children 12-23 months; maternal receipt of at least 2 tetanus vaccines using immunization cards or maternal self-report if not card.
Data from immunization cards or from self-reports when women did not have cards; approximately 50-60% of participants did not have immunization cards
|
2 year follow-up
|
Receipt of iron-folic acid tablets by month 4 and consumption of at least 90 tablets, using maternal survey response
Time Frame: 2 year follow-up
|
Assessed via self-report from representative sample of mothers of children aged 0-11 months; item created for Ananya Survey.
|
2 year follow-up
|
Clean Cord Care
Time Frame: 2 year follow-up
|
Assessed via self-report from representative sample of mothers of children aged 0-11 months
|
2 year follow-up
|
Kangaroo Mother Care (skin to skin care)
Time Frame: 2 year follow-up
|
Assessed via self-report from representative sample of mothers of children aged 0-11 months
|
2 year follow-up
|
Delayed Bath
Time Frame: 2 year follow-up
|
Assessed via self-report from representative sample of mothers of children aged 0-11 months
|
2 year follow-up
|
Initiation of Breastfeeding
Time Frame: 2 year follow-up
|
Assessed via self-report from representative sample of mothers of children aged 0-11 months
|
2 year follow-up
|
Nothing applied to cord or umbilicus
Time Frame: 2 year follow-up
|
Assessed via self-report from representative sample of mothers of children aged 0-11 months
|
2 year follow-up
|
Health worker placed child unclothed on mother's chest/abdomen in skin-to-skin contact
Time Frame: 2 year follow-up
|
Assessed via self-report from representative sample of mothers of children aged 0-11 months
|
2 year follow-up
|
First bath delayed by two or more days
Time Frame: 2 year follow-up
|
Assessed via self-report from representative sample of mothers of children aged 0-11 months
|
2 year follow-up
|
Breastfed child within one hour of birth
Time Frame: 2 year follow-up
|
Assessed via self-report from representative sample of mothers of children aged 0-11 months
|
2 year follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB-39719
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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