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CompletedNCT03406221ICT-CCSUpdated Apr 19, 2023

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

An interventional study of Information Communication Technology Continuum of Care Service and Control Condition in Health, Pregnancy and Infant, sponsored by Stanford University. Completed. Open to female participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-19.

Sponsored by Stanford University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
3,112
Allocation
Non-randomized
Ages
15 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Health
  • Pregnancy
  • Infant
  • Nutrition
  • Child
03

Who can participate

Ages eligible
15 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Mothers of infants 0-12 months residing in the catchment area of the subcenters

Exclusion criteria

Exclusion Criteria:

-

04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,112 participants (actual)

Study arms

  • Experimental
    Intervention arm

    Behavioral: Information Communication Technology Continuum of Care Service

  • Active comparator
    Control Arm

    Other: Control Condition

Interventions

  • BehavioralInformation 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.

  • OtherControl Condition

    Standard of care

05

What researchers measure

Primary outcomes

  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

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

    Time frame: 2 year follow-up

  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

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

    Time frame: 2 year follow-up

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

    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.

    Time frame: 2 year follow-up

  4. Immunizations

    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

    Time frame: 2 year follow-up

  5. Receipt of iron-folic acid tablets by month 4 and consumption of at least 90 tablets, using maternal survey response

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

    Time frame: 2 year follow-up

  6. Clean Cord Care

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

    Time frame: 2 year follow-up

  7. Kangaroo Mother Care (skin to skin care)

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

    Time frame: 2 year follow-up

  8. Delayed Bath

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

    Time frame: 2 year follow-up

  9. Initiation of Breastfeeding

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

    Time frame: 2 year follow-up

  10. Nothing applied to cord or umbilicus

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

    Time frame: 2 year follow-up

  11. Health worker placed child unclothed on mother's chest/abdomen in skin-to-skin contact

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

    Time frame: 2 year follow-up

  12. First bath delayed by two or more days

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

    Time frame: 2 year follow-up

  13. Breastfed child within one hour of birth

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

    Time frame: 2 year follow-up

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Carmichael SL, Mehta K, Raheel H, Srikantiah S, Chaudhuri I, Trehan S, Mohanty S, Borkum E, Mahapatra T, Weng Y, Kaimal R, Sivasankaran A, Sridharan S, Rotz D, Tarigopula UK, Bhattacharya D, Atmavilas Y, Munar W, Rangarajan A, Darmstadt GL; Ananya Study Group. Effects of team-based goals and non-monetary incentives on front-line health worker performance and maternal health behaviours: a cluster randomised controlled trial in Bihar, India. BMJ Glob Health. 2019 Aug 26;4(4):e001146. doi: 10.1136/bmjgh-2018-001146. eCollection 2019. PubMed 31543982 ↗

Individual participant data

Plan to share: Yes

08

Registry details

Key details

Study ID
NCT03406221
Lead sponsor
Stanford University
Collaborators
Bill and Melinda Gates Foundation
Responsible party
Gary Darmstadt (Associate Dean for Maternal and Child Health, Stanford University) — Principal investigator
First posted
Jan 23, 2018
Start date
Jan 1, 2012
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014
Last update
Apr 19, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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