About this trial
DED 2.0 is a stepped-wedge cluster-randomized trial testing whether an integrated digital health ecosystem (KuApps, a service-monitoring dashboard, AI-assisted OCR for handwritten records, two-way WhatsApp-based health communication, and an automated worker-support tool) improves the completeness and timeliness of maternal and neonatal primary health care services, delivered through 45 Puskesmas in Garut Regency, West Java, Indonesia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Sequential
Treatments tested in this trial
Digitally Enabled District (DED)
DeviceThe research adopts a stepped-wedge cluster-randomized design. Puskesmas are randomized sequentially to receive the intervention. Following a one-month baseline (retrospective data of Aug-Sept, taken in October), an additional set of 15 clusters begins the intervention at the start of each three-month step: step one covers randomisation and digital-readiness training for that wave, and the remainder of the step is given over to monitoring utilisation of the digital platform. Three successive steps of three months each follow this pattern until the full sample is covered, within a 9-month rollout-and-monitoring window.
Treatment groups
Trial outcomes
Primary outcomes
Completeness of Antenatal Care (ANC) Services within the Gestational-Age Window
Completeness of ANC services within the gestational-age window, in accordance with the recommended schedule and standard: Trimester 1 (1 visit, 1 ultrasound, 1 physician examination); Trimester 2 (2 visits); Trimester 3 (3 visits, 1 ultrasound, 1 physician examination). Binary, individual-level: 1 = received all scheduled ANC contacts within the nationally recommended gestational-age windows; 0 = otherwise. Denominator = all eligible pregnant women registered at the cluster in that cluster-period. Analysed via generalised linear mixed model with a cluster random effect and categorical calendar period as a fixed effect (Hussey \& Hughes, 2007). This is the study's single registered primary outcome; ANC "12T" completeness, PNC completeness, and PNC standard-assessment completeness are secondary outcomes.
Secondary outcomes
Proportion of Participants with Timely ANC Contacts
Proportion of pregnant women for whom mandated ANC visits are documented within the correct gestational-age window (per trimester schedule) in routine facility records (KuApps and Legacy Apps). Coded 1 = Timely; 0 = Not timely
Proportion of Participants with Complete Postnatal Care (PNC)
Proportion of postpartum women for whom all four scheduled PNC contacts are documented by a health worker in routine facility records (KuApps and Legacy Apps): PNC1 (6 hours-2 days), PNC2 (3-7 days), PNC3 (8-28 days), PNC4 (29-42 days). Coded 0 = Incomplete, 1 = Complete.
Proportion of Participants with a Complete Standard PNC Assessment
Proportion of postpartum women with all 14 mandated components of the Book of KIA standard PNC assessment, documented in routine facility records (KuApps and Legacy Apps). Components include breast examination (assessment of lactation/breastfeeding), bleeding assessment, examination of the birth canal/perineum, Vitamin A administration, postpartum family planning, mental health screening, counselling, and case management. Documented in routine facility records (KuApps and Legacy Apps)
Proportion of Neonates with Complete Neonatal Visits
Proportion of neonates for whom all three neonatal visits (KN1, KN2, and KN3) fully documented in routine facility records (KuApps and Legacy Apps). Classified as incomplete if one or more visits are not documented. Coded 0 = Incomplete, 1 = Complete.
Sponsors and contacts
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Summit Institute for Development, Indonesia
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator
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