AzTrials
AzTrials

Digital HealthDEDNCT07842224

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 study testing Digitally Enabled District (DED) in people with Digital Health and Maternal Health Services, run by Summit Institute for Development, Indonesia at 1 site in Indonesia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
What is being tested?
Digitally Enabled District (DED)
Type of treatment
Vaccines, Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,800 participants
Where
1 siteIndonesia
Study dates
Oct 2026to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • The participant relocates permanently outside the study area before the outcome-observation window begins.
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yuni Dwi Setiyawati, B.Nutr, MHID, Dietitian, Master's degree contact

+6285337006810

yuni.setiyawati@sid-indonesia.org

Indonesia1 site

  • Summit Institute for Development

    Mataram, West Nusa Tenggara, 83238

    Yuni Dwi Setiyawati, B.Nutr, MHID, Dietitian, Master's degree, +6285337006810, yuni.setiyawati@sid-indonesia.org

Other trials in Indonesia

About this study

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

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.

Read the detailed description

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.

Being tested
Digitally Enabled District (DED)
Keywords
Randomised Controlled Trial, Digital Health, Maternal-Child Health Services, Telemedicine, Health information systems, Indonesia

What participants receive

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

  • Digitally Enabled District (DED)Device

    Also called DED 2.0

    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.

Study groups in NCT07842224
Study groupRoleWhat they receive
DED Intervention Group (Ecosystem of DED)ExperimentalPrescription 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
Receives: Device: Digitally Enabled District (DED)
Control Group (non-DED)No interventionLegacy 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.

What is being measured

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

  1. 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.

    Measured: From first ANC contact up to 40 weeks gestation, assessed up to 9 months

Secondary outcomes (38)

  1. 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

    Measured: Assessed at each gestational-age window, up to 40 weeks gestation

  2. 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.

    Measured: From delivery through 42 days postpartum

  3. 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)

    Measured: From delivery through 42 days postpartum

  4. 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.

    Measured: From birth through 28 days of age

  5. 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.

    Measured: From birth through 28 days of age

  6. 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.

    Measured: From birth through 28 days of age

  7. 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.

    Measured: From birth through 28 days of age

  8. 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

    Measured: At delivery, (up to 9 months from Puskesmas enrolment)

  9. 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)

    Measured: At delivery (up to 9 months from Puskesmas enrolment)

  10. 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

    Measured: At delivery (up to 9 months from Puskesmas enrolment)

  11. 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

    Measured: During pregnancy (from the first ANC contact, up to 40 weeks gestation), at delivery, and up to 42 days postpartum

  12. 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.

    Measured: During pregnancy (from the first ANC contact, up to 40 weeks gestation), at delivery, and up to 42 days postpartum

  13. 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)

    Measured: Assessed at each ANC contact, up to 40 weeks gestation

  14. 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)

    Measured: Assessed at each ANC contact, up to 40 weeks gestation

  15. 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)

    Measured: Assessed at each ANC contact, up to 40 weeks gestation

  16. Maternal Body Height

    Vertical distance from the soles of the feet to the top of the head of a person standing upright

    Measured: Assessed at each ANC contact, up to 40 weeks gestation

  17. 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)

    Measured: Assessed at each ANC contact, up to 40 weeks gestation

  18. 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

    Measured: Assessed at each ANC contact, up to 40 weeks gestation

  19. 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.

    Measured: At each ANC contact, up to 40 weeks gestation

  20. 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

    Measured: At each ANC contact, from first ANC contact up to 40 weeks gestation

  21. 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

    Measured: From study initiation through study completion, assessed up to 9 months

  22. 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

    Measured: Every 3 months, from study initiation through study completion, assessed up to 9 months

  23. 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

    Measured: from study initiation through study completion, assessed up to 9 months

  24. 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%).

    Measured: From study initiation through study completion, assessed up to 9 months

  25. 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.

    Measured: From study initiation through study completion, assessed up to 9 months

  26. 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

    Measured: From study initiation through study completion, assessed up to 9 months

  27. 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

    Measured: From study initiation through study completion, assessed up to 9 months

  28. 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%)

    Measured: From study initiation through study completion, assessed up to 9 months

  29. 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)

    Measured: From study initiation through study completion, assessed up to 9 months

  30. 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)

    Measured: From procurement through study completion, assessed up to 9 months

  31. 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)

    Measured: From application deployment through study completion, assessed up to 9 months

  32. 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)

    Measured: From integration initiation deployment through study completion, assessed up to 9 months

  33. 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)

    Measured: From study initiation through study completion, assessed up to 9 months

  34. 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

    Measured: From study initiation through study completion, assessed up to 9 months

  35. 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

    Measured: From initial expenditure through study completion, assessed up to 9 months

  36. 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

    Measured: From study initiation through study completion, assessed up to 9 months

  37. 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.

    Measured: From ANC1 through 42 days postpartum

  38. 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.

    Measured: At trial end, through study completion (up to 9 months of rollout and 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 posted25 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionJul 2027 (estimated)

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
Randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
10,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07842224
Sponsor's protocol ID
NV-083581
Acronym
DED
Status last verified
Sep 2026
First submitted
7 Sep 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data, together with the data dictionary, protocol, and Statistical Analysis Plan, will be made available upon request.

Publications

  • Carter BR, Hood K. Balance algorithm for cluster randomized trials. BMC Med Res Methodol. 2008 Oct 9;8:65. doi: 10.1186/1471-2288-8-65.

    PubMed 18844993

  • Farrugia P. Statistics in Brief: The Cluster Randomized Controlled Trial-What Is It and Why Is It Relevant to Research in Surgery? Clin Orthop Relat Res. 2021 Aug 1;479(8):1852-1857. doi: 10.1097/CORR.0000000000001859. No abstract available.

    PubMed 34157009

  • Organ M, Tandon SD, Diebold A, Johnson JK, Yeh C, Ciolino JD. Evaluating performance of covariate-constrained randomization (CCR) techniques under misspecification of cluster-level variables in cluster-randomized trials. Contemp Clin Trials Commun. 2021 Feb 16;22:100754. doi: 10.1016/j.conctc.2021.100754. eCollection 2021 Jun.

    PubMed 33732943

  • Ciolino JD, Diebold A, Jensen JK, Rouleau GW, Koloms KK, Tandon D. Choosing an imbalance metric for covariate-constrained randomization in multiple-arm cluster-randomized trials. Trials. 2019 May 28;20(1):293. doi: 10.1186/s13063-019-3324-5.

    PubMed 31138319

  • Hooper R, Quintin O, Kasza J. Efficient designs for three-sequence stepped wedge trials with continuous recruitment. Clin Trials. 2024 Dec;21(6):723-733. doi: 10.1177/17407745241251780. Epub 2024 May 21.

    PubMed 38773924

  • Kristunas C, Grayling M, Gray LJ, Hemming K. Mind the gap: covariate constrained randomisation can protect against substantial power loss in parallel cluster randomised trials. BMC Med Res Methodol. 2022 Apr 13;22(1):111. doi: 10.1186/s12874-022-01588-8.

    PubMed 35413793

  • Ivers NM, Halperin IJ, Barnsley J, Grimshaw JM, Shah BR, Tu K, Upshur R, Zwarenstein M. Allocation techniques for balance at baseline in cluster randomized trials: a methodological review. Trials. 2012 Aug 1;13:120. doi: 10.1186/1745-6215-13-120.

    PubMed 22853820

  • Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, Dixon-Woods M, Aldcroft A, Doussau A, Grayling M, Kristunas C, Goldstein CE, Campbell MK, Girling A, Eldridge S, Campbell MJ, Lilford RJ, Weijer C, Forbes AB, Grimshaw JM. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2018 Nov 9;363:k1614. doi: 10.1136/bmj.k1614.

    PubMed 30413417

  • Voldal EC, Hakhu NR, Xia F, Heagerty PJ, Hughes JP. swCRTdesign: An RPackage for Stepped Wedge Trial Design and Analysis. Comput Methods Programs Biomed. 2020 Nov;196:105514. doi: 10.1016/j.cmpb.2020.105514. Epub 2020 May 21.

    PubMed 32554025

  • Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.

    PubMed 16829207

Questions about this trial

What is this clinical trial studying?

A study testing Digitally Enabled District (DED) in people with Digital Health and Maternal Health Services, run by Summit Institute for Development, Indonesia at 1 site in Indonesia.

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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Yuni Dwi Setiyawati, B.Nutr, MHID, Dietitian, Master's degree (+6285337006810, yuni.setiyawati@sid-indonesia.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completeness of Antenatal Care (ANC) Services within the Gestational-Age Window (time frame: From first ANC contact up to 40 weeks gestation, assessed up to 9 months). 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 NCT07842224, which also lists 10 linked publications.

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 25 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in