Clinical trial Recruiting at 1 site Interventional Women only

Digitally Enabled Districts 2.0: Aimed at Improving Maternal and Neonatal Care in Garut

Official title: The Effect of Digitally Enabled District (DED 2.0) Ecosystem on the Completeness and Timeliness of Maternal and Neonatal Services in Primary Health Care: A Stepped-Wedge Cluster Randomised Trial in Garut Regency, Indonesia

Run by Summit Institute for Development, Indonesia · NCT07842224 · Data updated 2026-11-12

A stepped-wedge trial tests whether an integrated digital health ecosystem helps 45 local clinics in Garut improve the completeness and timeliness of maternal and neonatal care.

Quick facts

Study typeInterventional
SexWomen only
Enrollment10800 (estimated)
SponsorSummit Institute for Development, Indonesia
Academic / other
Locations1 site (Mataram, West Nusa Tenggara)
StatusRecruiting
StartedOctober 2026
Main results expectedMay 2027
Study endsJuly 2027
Registry record updatedOctober 27, 2026
Trial IDNCT07842224 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Pregnant women residing within the catchment area of participating Puskesmas in Garut who have registered pregnancies and consent to participate.

Probably not a fit

Pregnant women who relocate outside the study area before outcome observation or whose care is not captured by the participating Puskesmas may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

DED 2.0 tests an integrated digital health package, including KuApps, a service-monitoring dashboard, AI-assisted OCR for handwritten records, two-way WhatsApp communication, and an automated worker-support tool, to improve maternal and neonatal services at participating primary health centers in Garut Regency, Indonesia. The study uses a stepped-wedge cluster design to introduce the digital ecosystem across clinics and assess changes in data completeness, timeliness, and care coordination. It focuses on building digital infrastructure, workforce skills, and sustainable implementation to enable data-driven decision making and better care for mothers and babies. The project addresses fragmented health information systems by enabling real-time data integration and enhanced monitoring of service delivery. Outcomes center on routine maternal and neonatal indicators and the capacity for scale-up within primary health care settings.

Why it matters

Potential benefit: If successful, the digital ecosystem could lead to more complete and timely maternal and neonatal services and better use of health data to guide care.

How similar studies have gone: Prior digital health implementations in primary care show promise for improving data quality and service delivery, but effectiveness can vary by setting and integration level.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria (Pregnant Women):

* Mothers residing within the catchment area of a participating Puskesmas in Garut Regency during their pregnancy
* Pregnancy registered in the maternal health records of a participating Puskesmas within the study catchment area in Garut Regency
* The pregnant woman provides informed consent to participate in the study.

Exclusion Criteria (Pregnant Women):

\- The participant relocates permanently outside the study area before the outcome-observation window begins.

Inclusion Criteria (Puskesmas Level):

\- Located in Garut Regency; at baseline, the DED ecosystem had not been integrated into daily service operations.

Exclusion Criteria (Puskesmas Level):

* Puskesmas had fully implemented the DED ecosystem in daily practice before the study baseline period
* Puskesmas lacks adequate routine service data for outcome measurement throughout the study period

Where it's running

  • Summit Institute for Development
    Mataram, West Nusa Tenggara, Indonesia
    Recruiting

Study contacts

  • Principal investigator: Yuni Dwi Setiyawati, B.Nutr, MHID, Dietitian — Summit Institute for Development
  • Study coordinator: Yuni Dwi Setiyawati, B.Nutr, MHID, Dietitian, Master's degree
  • Email: yuni.setiyawati@sid-indonesia.org
  • Phone: +6285337006810

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.