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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03406221
Other study ID # IRB-39719
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2012
Est. completion date August 31, 2014

Study information

Verified date April 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3112
Est. completion date August 31, 2014
Est. primary completion date August 31, 2014
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 65 Years
Eligibility Inclusion Criteria: - Mothers of infants 0-12 months residing in the catchment area of the subcenters Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

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.
Other:
Control Condition
Standard of care

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Stanford University Bill and Melinda Gates Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 year follow-up
Primary 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. 2 year follow-up
Primary 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. 2 year follow-up
Primary 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 2 year follow-up
Primary 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. 2 year follow-up
Primary Clean Cord Care Assessed via self-report from representative sample of mothers of children aged 0-11 months 2 year follow-up
Primary Kangaroo Mother Care (skin to skin care) Assessed via self-report from representative sample of mothers of children aged 0-11 months 2 year follow-up
Primary Delayed Bath Assessed via self-report from representative sample of mothers of children aged 0-11 months 2 year follow-up
Primary Initiation of Breastfeeding Assessed via self-report from representative sample of mothers of children aged 0-11 months 2 year follow-up
Primary Nothing applied to cord or umbilicus Assessed via self-report from representative sample of mothers of children aged 0-11 months 2 year follow-up
Primary 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 2 year follow-up
Primary First bath delayed by two or more days Assessed via self-report from representative sample of mothers of children aged 0-11 months 2 year follow-up
Primary Breastfed child within one hour of birth Assessed via self-report from representative sample of mothers of children aged 0-11 months 2 year follow-up
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