An interventional study of Digitally Enabled District (DED) in Digital Health, Maternal Health Services and Prenatal Care, sponsored by Summit Institute for Development, Indonesia. Recruiting at 1 site in Indonesia. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Summit Institute for Development, Indonesia · Not applicable, Interventional, and Health services research
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.
DED 2.0 (Digitally Enabled Districts) is designed to examine whether integrated digital health tools can strengthen the performance of Primary Health Care (PHC) in Indonesia. The package targets several interconnected areas: (1) strengthening district-level human resources in core components of knowledge and skills for digitalisation; (2) establishing adaptable and modifiable digital infrastructure (e.g., data pipelines, dashboards, and KuApps) that local personnel can configure to their own needs; (3) building sustainable implementation capacity in both workforce skills and financing; and (4) enabling high-fidelity scale-up of digitalisation across Puskesmas, resulting in improvements in primary healthcare delivery.
While local health information systems face fragmentation, with multiple disconnected applications causing duplicate data entry, inconsistent indicators, and delayed decision-making, DED 2.0 addresses these issues by building an integrated digital system that enables seamless data integration across services, real-time monitoring of population health, improved coordination among health workers, and stronger data-driven planning and decision-making. This is expected to enhance the completeness, timeliness, visibility, and use of routine health data, allowing earlier identification of service gaps and high-risk cases, strengthening care coordination and follow-up, increasing timely referrals, and improving monitoring of maternal and neonatal services.
Beyond technology adoption, DED 2.0 places equal emphasis on strengthening human resources: training health workers to use the digital systems, building local technical capacity, fostering coaching and peer learning through selected health-worker "Champions," and accelerating digital adoption across facilities through a tiered "train the trainer" model. DED is hypothesised to increase the completeness and timeliness of antenatal, postnatal, and neonatal services; improve facility-based delivery and skilled birth attendance; and ultimately contribute to improved maternal and neonatal outcomes.
The trial uses a cluster-randomised stepped-wedge design, with Puskesmas as the unit of intervention, in a single district, Garut Regency, West Java, Indonesia. A one-month baseline (retrospective data of Aug-Sept, taken in October) is followed by three sequential steps of three months each, at each of which a new sequence of 15 clusters (one-third of the 45 eligible PHCs) crosses over from control to intervention status. All 45 sites have received the intervention by the start of the third step, reaching full coverage in April 2027; outcome monitoring for the final wave continues through the end of that step in May 2027, a 9-month rollout-and-monitoring window in total. Each cluster undergoes an initial preparatory stage, a phased pre-intervention digital-readiness phase, followed by a data-driven action phase, sequencing digital readiness first to improve managerial and behavioural accuracy and consistency.
DED is expected to serve as a replicable framework for district-level digital health transformation across Indonesia, generating practical evidence on implementing and sustaining digital health systems in primary health care and informing national scale-up strategies.
Summit Institute for Development, Indonesia is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Pregnant Women):
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):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prescription for Action (DED Model), a system-level intervention consisting of: KuApps, a digital health application (BidanKu, KaderKu) for frontline health workers, built on OpenSRP/FHIR standards for SATUSEHAT integration; supports electronic patient registration, centralised ID management, and structured care-plan tracking. PWS Dashboard, central monitoring dashboard tracking primary healthcare services and operational data (staffing, drug procurement, vaccine logistics) across District (Dinas Kesehatan), PHC, and Village (Posyandu) levels. AI OCR, converts handwritten text from Maternal and Child Health (KIA) books into structured digital data for automated form-filling and reporting. Health communication: two-way maternal/infant/child health communication via WhatsApp
Device: Digitally Enabled District (DED)
Legacy Apps: digital health application (SIGIZI, Electronic Medical Records, and ASIK) for frontline health workers. There will be no PWS Dashboard, AI OCR, and Health communication in the control group.
The 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.
Also known as: DED 2.0
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.
Time frame: From first ANC contact up to 40 weeks gestation, assessed up to 9 months
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
Time frame: Assessed at each gestational-age window, up to 40 weeks gestation
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.
Time frame: From delivery through 42 days postpartum
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)
Time frame: From delivery through 42 days postpartum
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.
Time frame: From birth through 28 days of age
Proportion of Neonates Receiving Complete Essential Neonatal Care
Proportion of neonates for whom all required essential neonatal care components are documented in routine facility records (KuApps and Legacy Apps). Assessing the completeness of all required essential neonatal care components documented, comprising eye antibiotic ointment, Vitamin K administration, umbilical cord care, early initiation of breastfeeding, and exclusive breastfeeding. Coded 0 = Incomplete, 1 = Complete.
Time frame: From birth through 28 days of age
Proportion of Neonates Receiving Complete Standard Neonatal Examination
Completeness of the standard neonatal examination, comprising: KN1: weight measurement, length measurement, head circumference measurement, breastfeeding assessment, umbilical cord care, Vitamin K1 administration\*, eye ointment/drops\*, Hepatitis B immunisation, congenital hypothyroidism screening (after 24 hours), congenital heart disease screening, triple elimination screening. KN2: breastfeeding assessment, umbilical cord examination/care, danger-sign assessment, jaundice identification, Hepatitis B immunisation\*, congenital hypothyroidism screening (if not yet given), triple elimination screening. KN3: breastfeeding assessment, umbilical cord examination/care, danger-sign assessment, jaundice identification, congenital hypothyroidism screening (if not yet given), triple elimination screening. Coded 0 = Incomplete, 1 = Complete.
Time frame: From birth through 28 days of age
Proportion of neonates with timely neonatal visits
Proportion of neonates for whom each neonatal visit is documented within the appropriate age window in routine facility records (KuApps and Legacy Apps): KN1 (6-48 hours), KN2 (3-7 days), KN3 (8-28 days). Coded 1 = Timely; 0 = Not timely.
Time frame: From birth through 28 days of age
Proportion of Pregnancy Outcomes
Proportion of recorded pregnancies resulting in a live birth and non-live birth (such as stillbirth or miscarriage/abortion), ascertained at delivery from routine facility records (KuApps and Legacy Apps). Coded 0 = Death/stillbirth, 1 = Miscarriage/abortion, 2 = Live birth
Time frame: At delivery, (up to 9 months from Puskesmas enrolment)
Proportion of Neonates with Birth Weight ≥ 2,500 g
Proportion of live-born neonates with birth weight ≥ 2,500 g, measured in grams using a calibrated infant scale and recorded in routine facility records (KuApps and Legacy Apps). Coded 1 = ≥ 2,500 g; 0 = \< 2,500 g (low birth weight)
Time frame: At delivery (up to 9 months from Puskesmas enrolment)
Proportion of Facility-Based Deliveries
Proportion of deliveries occurring at a health facility, ascertained from routine facility records (KuApps and Legacy Apps). Coded 1 = Facility-based delivery; 0 = Delivery outside a health facility
Time frame: At delivery (up to 9 months from Puskesmas enrolment)
Proportion of Deliveries Attended by a Skilled Birth Attendant
Personnel who assisted the delivery process, ascertained from routine facility records Coded 0 = Non-health-worker, 1 = Health worker
Time frame: During pregnancy (from the first ANC contact, up to 40 weeks gestation), at delivery, and up to 42 days postpartum
Proportion of Documented Complications with Documented Management
Proportion of participants with a documented obstetric complication for whom a documented set of clinical actions and care is recorded in routine facility records (KuApps and Legacy Apps). Coded 1 = Documented management; 0 = Not documented.
Time frame: During pregnancy (from the first ANC contact, up to 40 weeks gestation), at delivery, and up to 42 days postpartum
Mean Arterial Pressure (MAP)
A person's average blood pressure in the arteries during one complete cardiac cycle recorded as a continuous variable in mmHg. An additional ordinal variable derived from MAP, categorising the continuous value into clinical groups: 0 = Normal (\<90 mmHg) 1. = Elevated (≥90-\<92) 2. = Stage 1 hypertension (≥92-\<96) 3. = Stage 2 hypertension (≥96)
Time frame: Assessed at each ANC contact, up to 40 weeks gestation
Blood Pressure (Systolic)
The pressure inside the artery when the heart contracts and pumps blood through the body. the "top number" of a blood pressure reading. Recorded as a continuous variable in mmHg in routine facility records (KuApps and LegacyApps). An additional ordinal variable derived from systolic blood pressure for systolic status: 0 = Normal (\<130 mmHg) 1. = Stage 1 hypertension (≥130-\<140 mmHg) 2. = Stage 2 hypertension (≥140 mmHg)
Time frame: Assessed at each ANC contact, up to 40 weeks gestation
Blood Pressure (Diastolic)
The pressure inside the artery when the heart is at rest. Recorded as a continuous variable in mmHg. the "bottom number" of a blood pressure reading, recorded in routine facility records (KuApps and Legacy Apps). Reported as a continuous variable. An additional ordinal variable derived from diastolic blood pressure for diastolic status: 0 = Normal \< 80 mmHg 1. = Stage 1 hypertension (80-89 mmHg) 2. = Stage 2 hypertension (\>90 mmHg)
Time frame: Assessed at each ANC contact, up to 40 weeks gestation
Maternal Body Height
Vertical distance from the soles of the feet to the top of the head of a person standing upright
Time frame: Assessed at each ANC contact, up to 40 weeks gestation
Maternal Body Weight
Maternal's total amount of fluid, fat, muscle, and bone mineral in the human body, as measured using a scale, expressed in kilograms (kg)
Time frame: Assessed at each ANC contact, up to 40 weeks gestation
Body Mass Index (BMI)
Maternal BMI which considered as an index used to determine ideal body weight based on the ratio of weight to height. Reported as a continuous variable. Descriptive categorisation: underweight \<18.5 normal 18,5-22,9 overweight 23-24.9 obesity type 1: 25-29.9 obesity type 2: \>30
Time frame: Assessed at each ANC contact, up to 40 weeks gestation
Maternal Mid-Upper Arm Circumference (MUAC)
Maternal upper arm circumference measured in centimetres using a standard non-elastic MUAC measuring tape at the first ANC contact, recorded in routine facility records (KuApps and Legacy Apps). Reported as a continuous variable.
Time frame: At each ANC contact, up to 40 weeks gestation
Proportion of participants with Chronic Energy Deficiency (CED)
Proportion of pregnant women are classified as having Chronic Energy Deficiency (CED) if their Mid-Upper Arm Circumference (MUAC) is \< 23.5 cm, measured at the first Antenatal Care (ANC) visit
Time frame: At each ANC contact, from first ANC contact up to 40 weeks gestation
Occurrence of Stock Out of Essential ANC Medications and Supplements per Month
Occurrence of at least one day of unavailability (recorded stock = 0) during the observation month for essential ANC medications and supplements, such as Iron-Folic Acid (IFA) tablets, calcium, and folic acid, ascertained from monthly Puskesmas pharmacy and logistics records. Coded 1 = At least one stock-out day during the month; 0 = No stock out
Time frame: From study initiation through study completion, assessed up to 9 months
Puskesmas Performance Score (PKP)
Aggregate score of Puskesmas (Community Health Centre) service performance, ascertained from the Ministry of Health's Puskesmas Performance Assessment (Penilaian Kinerja Puskesmas, called PKP) monthly tabulations. Reported as a continuous score per Puskesmas per observation month
Time frame: Every 3 months, from study initiation through study completion, assessed up to 9 months
Workload Distribution per Health Worker
Number of pregnant women served per health worker (midwife or cadre) per Puskesmas per observation month, computed from routine service records (KuApps and Legacy Apps) divided by the roster of active ANC providers per Puskesmas. Reported as a continuous count
Time frame: from study initiation through study completion, assessed up to 9 months
Proportion of ANC contacts recorded by cadres (Task Shifting)
Proportion of documented ANC contacts recorded by cadres compared with the total number of ANC contacts documented during the period, ascertained from KuApps and Legacy Apps entry logs. Reported as a continuous proportion (0-100%).
Time frame: From study initiation through study completion, assessed up to 9 months
Proportion of Health Workers Actively Using the KuApps per Observation Month
Proportion of registered health workers and cadres per Puskesmas who actively used the KuApps application at least once during the observation month, ascertained from KuApps user activity logs (log-in timestamps and data entry events). Reported as a continuous proportion (0-100%) per Puskesmas per month.
Time frame: From study initiation through study completion, assessed up to 9 months
Availability of digital infrastructure
Availability of supporting devices and connectivity (computers/tablets, internet connection) at health facilities. This is ascertained by facility inventory checklist adapted from the Digital Readiness Assessment (DRA). Coded 1 = Fully available (device + connectivity); 0 = Not fully available
Time frame: From study initiation through study completion, assessed up to 9 months
Electronic medical record integration
Connectivity status of the Puskesmas recording system with the national Electronic Medical Record system (SATUSEHAT), ascertained by facility inventory checklist and confirmed via SATUSEHAT integration logs. Coded 1 = Integrated; 0 = Not integrated
Time frame: From study initiation through study completion, assessed up to 9 months
Proportion of routine reports submitted on time
Proportion of routine Puskesmas reports (monthly ANC, PNC, and neonatal reports) submitted by the established Dinas Kesehatan deadline during the observation month, ascertained from Dinas Kesehatan report intake logs. Reported as a continuous proportion (0-100%)
Time frame: From study initiation through study completion, assessed up to 9 months
Training Costs
Total cost of training healthcare workers using the DED (trainer's fee, healthcare worker training time, materials, transportation), per Puskesmas. Reported in Indonesian Rupiah (IDR)
Time frame: From study initiation through study completion, assessed up to 9 months
Infrastructure cost
Hardware and network costs (such as tablets/mobile phones, servers/cloud, internet) measured based on economic lifespan, attributable to the DED ecosystem, annualised over economic lifespan, ascertained from a prospective cost inventory. Reported in Indonesian Rupiah (IDR)
Time frame: From procurement through study completion, assessed up to 9 months
Dashboard and Software Costs
Annualised development and licensing costs of the KuApps application and PWS dashboard attributable to the DED ecosystem, ascertained from a prospective cost inventory. Reported in Indonesian Rupiah (IDR)
Time frame: From application deployment through study completion, assessed up to 9 months
Digital interoperability/integration costs
Costs of RME and AI-OCR integration attributable to the DED ecosystem, ascertained from a prospective cost inventory. Reported in Indonesian Rupiah (IDR)
Time frame: From integration initiation deployment through study completion, assessed up to 9 months
Technical support & maintenance costs
Ongoing operational costs of HealthComm, Tableau, PWS, and KuApps dashboard servers per period, ascertained from a prospective cost inventory. Reported in Indonesian Rupiah (IDR)
Time frame: From study initiation through study completion, assessed up to 9 months
Healthcare service costs per unit
Cost of providing ANC, PNC, delivery, and referral services per service unit, ascertained from a prospective service costing exercise (facility-based micro-costing). Reported in Indonesian Rupiah (IDR) per service unit
Time frame: From study initiation through study completion, assessed up to 9 months
Cost time horizon and period
The timeframe over which costs are calculated covering the identification of incurred costs and the duration (time horizon) of the study, as well as costs categorized by source and expenditure period. Reported as a structured cost inventory in Indonesian Rupiah (IDR), stratified by source and expenditure period
Time frame: From initial expenditure through study completion, assessed up to 9 months
Number of additional services
Difference in the number of documented services and visits delivered between the intervention and control periods, ascertained from routine facility records (KuApps and Legacy Apps). Reported as a continuous count
Time frame: From study initiation through study completion, assessed up to 9 months
Number of Participants completing the complete continuum of maternal care
Number of mothers documented as completing the full continuum: ANC (per standard), delivery, and PNC (all four contacts), ascertained from routine facility records (KuApps and Legacy Apps). Reported as a continuous count.
Time frame: From ANC1 through 42 days postpartum
Incremental Cost per Disability-Adjusted Life Year (DALY) Averted
Incremental cost of the DED ecosystem per DALY averted, computed by linking observed improvements in maternal and neonatal care coverage to modelled reductions in mortality and morbidity risk using published transition-model parameters. Reported as IDR (Indonesian Rupiah) per DALY averted.
Time frame: At trial end, through study completion (up to 9 months of rollout and follow-up)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data, together with the data dictionary, protocol, and Statistical Analysis Plan, will be made available upon request.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning after publication of the primary results
Access criteria: Requests reviewed and approved by Summit Institute for Development (SID), as the study's operational point of contact, notwithstanding Gates Foundation's role as formal Sponsor
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Summit Institute for Development, Indonesia