ICT-CCS: Use of Mobile Technology by Community-Based Health Workers to Promote Maternal and Child Health in Bihar, India

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT03406221
Collaborator
Bill and Melinda Gates Foundation (Other)
3,112
2
32

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Information Communication Technology Continuum of Care Service
  • Other: Control Condition
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
3112 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
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
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Aug 31, 2014
Actual Study Completion Date :
Aug 31, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention arm

Behavioral: Information Communication Technology Continuum of Care Service
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.

Active Comparator: Control Arm

Other: Control Condition
Standard of care

Outcome Measures

Primary Outcome Measures

  1. 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 [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. 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 [2 year follow-up]

    Assessed via self-report from representative sample of mothers of children aged 0-11 months; items created for Ananya Survey.

  3. Any complementary feeding of solid or semisolid food for infants aged 6-11 months, using maternal survey response [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.

  4. Immunizations [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

  5. Receipt of iron-folic acid tablets by month 4 and consumption of at least 90 tablets, using maternal survey response [2 year follow-up]

    Assessed via self-report from representative sample of mothers of children aged 0-11 months; item created for Ananya Survey.

  6. Clean Cord Care [2 year follow-up]

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

  7. Kangaroo Mother Care (skin to skin care) [2 year follow-up]

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

  8. Delayed Bath [2 year follow-up]

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

  9. Initiation of Breastfeeding [2 year follow-up]

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

  10. Nothing applied to cord or umbilicus [2 year follow-up]

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

  11. Health worker placed child unclothed on mother's chest/abdomen in skin-to-skin contact [2 year follow-up]

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

  12. First bath delayed by two or more days [2 year follow-up]

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

  13. Breastfed child within one hour of birth [2 year follow-up]

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Mothers of infants 0-12 months residing in the catchment area of the subcenters
Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Stanford University
  • Bill and Melinda Gates Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gary Darmstadt, Associate Dean for Maternal and Child Health, Stanford University
ClinicalTrials.gov Identifier:
NCT03406221
Other Study ID Numbers:
  • IRB-39719
First Posted:
Jan 23, 2018
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 23, 2018