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HealthICT-CCSNCT03406221

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

A study testing Information Communication Technology Continuum of Care Service in people with Health and Pregnancy, run by Stanford University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 15 to 65 years, women only
Conditions the study is for
Health, Pregnancy, Infant
What is being tested?
Information Communication Technology Continuum of Care Service
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,112 participants
Where
No sites listed yet
Study dates
1 Jan 2012to 31 Aug 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 65 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • -

About this study

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

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.

Being tested
Information Communication Technology Continuum of Care Service, Control Condition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Information Communication Technology Continuum of Care ServiceBehavioural

    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.

  • Control ConditionOther

    Standard of care

Study groups in NCT03406221
Study groupRoleWhat they receive
Intervention armExperimentalNot described
Receives: Behavioral: Information Communication Technology Continuum of Care Service
Control ArmActive comparatorNot described
Receives: Other: Control Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 2 year follow-up

  6. Clean Cord Care

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

    Measured: 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

    Measured: 2 year follow-up

  8. Delayed Bath

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

    Measured: 2 year follow-up

  9. Initiation of Breastfeeding

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 2 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start1 Jan 2012
  3. Primary completion31 Aug 2014
  4. Study completion31 Aug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03406221
Sponsor's protocol ID
IRB-39719
Acronym
ICT-CCS
Status last verified
Apr 2023
First submitted
23 Oct 2017
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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

Questions about this trial

What is this clinical trial studying?

A study testing Information Communication Technology Continuum of Care Service in people with Health and Pregnancy, run by Stanford University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03406221, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.

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