Primary Health Care for ChildrenKSI-RCTNCT07027384

Evaluation of Digital Decision-support Tool for Child Nutritional Monitoring: a Protocol for Cluster Randomized Controlled Trial in Urban and Semi-Urban Areas in Indonesia

A study testing Web-Based Apps PRIMA, Apps PRIMA Mobile and Advance GEDSI Training in people with Primary Health Care for Children and Nutritional Status, run by Center for Indonesia's Strategic Development Initiatives at 6 sites in Indonesia.

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

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Primary Health Care for Children, Nutritional Status
What is being tested?: Web-Based Apps PRIMA, Apps PRIMA Mobile and Advance GEDSI Training
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,091 participants
Where: 6 sitesIndonesia
Study dates: 8 Jul 2025to 1 Jul 2026
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Community Health Workers (CHWs) assigned to work in one of the eligible Posyandu PN PRIMA
Consent to participate in the program and the study

Who cannot join

Community Health Workers working outside of Posyandu PN PRIMA

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Indonesia6 sites

Puskesmas Sukmajaya
Depok, West Java, 16411
Puskesmas Abadijaya
Depok
Puskesmas Baktijaya
Depok
Puskesmas Cinangka
Depok
Puskesmas Limo
Depok
Puskesmas Sukatani
Depok

Other trials in Indonesia

About this study

This research is a collaborative study between Indonesia's Strategic Development Initiatives (CISDI), Knowledge Partnership Platform Australia - Indonesia (KONEKSI), Center on Child Protection and Wellbeing (PUSKAPA), and Center for Development Economics and Sustainability at Monash University. This study is a part of the PN PRIMA research universe, which is a program lead by CISDI with a focus of strengthening the primary healthcare facilities of Indonesia, known as Integrated Health Posts (Posyandu). This project supports the Ministry of Health's (MoH) flagship program: the Integrated Primary Health Care Services (ILP).

This study aims to evaluate the impact of implementing a digital mHealth app, called the PN PRIMA app, in enhancing the work quality of Community Health Workers working in Posyandu, known as Kader. This study specifically improve the PN PRIMA app from a web-based platform to a mobile application. We aim to improve data quality, streamline service delivery workflows, and enhance decision-making support for community health workers. The enhanced version incorporates new features and Gender Equality, Disability, and Social Inclusion (GEDSI) framework to strengthen primary health care delivery.

Impact evaluation of the study will be conducted through a three-arm parallel cluster randomized controlled trial. Posyandu will be the unit in which randomization will occur. The primary outcomes focuses on the improvements of Kader Posyandu performance in delivering follow-up home visits and how the app effectively support Kader in delivering nutrition interventions for children under five years of age.

The study will be conducted in the Puskesmas PN PRIMA catchment area, located in Kabupaten Bekasi and Kota Depok, focusing the intervention at the Posyandu level. In total, 38 Posyandu out of 12 health centers (Puskesmas) across the two areas will be recruited to take part in this study.

Conditions: Primary Health Care for Children, Nutritional Status
Being tested: Web-Based Apps PRIMA, Apps PRIMA Mobile, Advance GEDSI Training
Keywords: mHealth, decision-support tools, community health workers, primary health care, posyandu

What participants receive

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

Web-Based Apps PRIMADevice
Apps PRIMA (posyandu monitoring tools) is delivered using a web-based app accessible through web browsers with basic core functionalities
Apps PRIMA MobileDevice
Enhancement of Apps PRIMA delivered using a standalone mobile app. Enhanced core functionalities include the looping system of children measurements, automatic charts, and GEDSI-sensitive features
Advance GEDSI TrainingBehavioural
Additional training to address vulnerabilities in communities and empathetic service from CHWs to caregivers. The training is a follow-up training from a basic GEDSI materials already delivered to CHWs

Study groups in NCT07027384
Study group	Role	What they receive
Web-Based App	Active comparator	The first group of Posyandu will use the standard web-based version of the PN PRIMA app in addition to the routine nutritional services. This web-based version is accessible only through browsers and includes the basic functions such as reporting key health indicators and in-app warning alerts. This group will serve as the control group, using the baseline functionality of the app currently available to Kader Receives: Device: Web-Based Apps PRIMA
Mobile-Based App	Experimental	This group will receive access to the mobile version of PN PRIMA app. The mobile-based version has additional features unavailable in the web-based version. The mobile-based version has access to the PN PRIMA app using a standalone mobile app. In addition to the standard reporting of patients' key health indicators and in-app warning message alerts which are available in the web-based version, the mobile app includes active notifications for Kader, which serve as reminders to encourage Kader in making on-time assistance for healthcare beneficiaries, especially those considered requiring special attention (kunjungan khusus) and for those facing access barriers who need regular checkups (kunjungan rutin). Receives: Device: Apps PRIMA Mobile
Mobile + GEDSI Training	Experimental	In addition to using the new mobile-app as arm 2, this arm will include training module that focuses on identifying and addressing caregiver and community vulnerabilities. This training is designed to strengthen Kader's capacity in recognizing risk factors that may contribute to malnutrition, such as social, economic, and environmental barriers to care. The training emphasizes empathetic and responsive service delivery, equipping Kader not only with technological tools but also with improved understanding and skills for working in complex community settings. This integrated intervention enables the study to assess the combined effect of digital tools and conventional capacity-building efforts on service delivery outcomes. Receives: Device: Apps PRIMA Mobile; Behavioral: Advance GEDSI Training

What is being measured

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

At least one visitation completed
The proportion of U5 children's visitation cycles in which CHWs completed at least the one required home visitation according to the app-generated schedule. For each cycle, a score of 1 is coded if the assigned CHW completes at least one visitation session within the scheduled time window, and 0 if none of the scheduled visitation was delivered.
The final proportion is calculated as the number of cycles coded 1 in proportion to the total number of visitation cycles assigned to the CHW.
Measured: From intervention roll-out to the end of intervention period in 6 months

Secondary outcomes (4)

Proportion of on-time and completed visitation
The measure captures the proportion of required visits that were completed on time for each child's visitation cycle. Within each cycle, visits conducted within the recommended time window were assigned a score of 1. The total number of on-time visits for each child was calculated by summing the score. The final proportion was calculated by dividing the score of actual on-time visits by the total number of required visits.
Measured: Every visitation conducted by CHW during the intervention period, marked by 6-month after the first use of app after training
Knowledge and Attitude of CHWs
Kader's knowledge on children's nutritional needs and status, and attitudes toward vulnerable population
Measured: Measured in baseline (pre-intervention; maximum 1 months before training intervention) and endline (post-intervention; minimum 6 months intervention implementation)
Caregiver's knowledge and attitude
Parents/caregivers knowledge on children's nutrition and primary care services, and attitudes towards primary healthcare services
Measured: Measured in baseline (pre-intervention; maximum 1 months before training intervention) and endline (post-intervention; minimum 6 months intervention implementation)
Caregiver's satisfaction on healthcare
Parents/caregivers satisfaction towards primary healthcare services
Measured: Measured in baseline (pre-intervention; maximum 1 months before training intervention) and endline (post-intervention; minimum 6 months intervention implementation)

Timeline

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

8 Jul 20251 Jul 2026

First posted18 Jun 2025
Study start8 Jul 2025
Primary completion31 May 2026
Study completion1 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary Health Care for ChildrenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 1,091 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07027384
Sponsor's protocol ID: koneksiRCT
Other IDs: 1447/CRG/2024/46-CISDI
Acronym: KSI-RCT
Status last verified: Jul 2026
First submitted: 9 Jun 2025
Last updated: 2 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Digital Decision-support Tool for Child Nutritional Monitoring: a Protocol for Cluster Randomized Controlled Trial in Urban and Semi-Urban Areas in Indonesia
ClinicalTrials.gov ID: NCT07027384
Acronym / sponsor ID: KSI-RCT / koneksiRCT
Conditions: Primary Health Care for Children, Nutritional Status
Keywords: mHealth, decision-support tools, community health workers, primary health care, posyandu
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,091 participants (actual)
Lead sponsor: Center for Indonesia's Strategic Development InitiativesUniversity, hospital or other
Study start: 8 Jul 2025 (actual)
Primary completion: 31 May 2026 (actual)
Study completion: 1 Jul 2026 (actual)
First posted: 18 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
Web-Based App	Active comparator	Device: Web-Based Apps PRIMAThe first group of Posyandu will use the standard web-based version of the PN PRIMA app in addition to the routine nutritional services. This web-based version is accessible only through browsers and includes the basic functions such as reporting key health indicators and in-app warning alerts. This group will serve as the control group, using the baseline functionality of the app currently available to Kader
Mobile-Based App	Experimental	Device: Apps PRIMA MobileThis group will receive access to the mobile version of PN PRIMA app. The mobile-based version has additional features unavailable in the web-based version. The mobile-based version has access to the PN PRIMA app using a standalone mobile app. In addition to the standard reporting of patients' key health indicators and in-app warning message alerts which are available in the web-based version, the mobile app includes active notifications for Kader, which serve as reminders to encourage Kader in making on-time assistance for healthcare beneficiaries, especially those considered requiring special attention (kunjungan khusus) and for those facing access barriers who need regular checkups (kunjungan rutin).
Mobile + GEDSI Training	Experimental	Device: Apps PRIMA Mobile, Behavioral: Advance GEDSI TrainingIn addition to using the new mobile-app as arm 2, this arm will include training module that focuses on identifying and addressing caregiver and community vulnerabilities. This training is designed to strengthen Kader's capacity in recognizing risk factors that may contribute to malnutrition, such as social, economic, and environmental barriers to care. The training emphasizes empathetic and responsive service delivery, equipping Kader not only with technological tools but also with improved understanding and skills for working in complex community settings. This integrated intervention enables the study to assess the combined effect of digital tools and conventional capacity-building efforts on service delivery outcomes.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Community Health Workers (CHWs) assigned to work in one of the eligible Posyandu PN PRIMA
Consent to participate in the program and the study

Key exclusion criteria (1 listed)

Community Health Workers working outside of Posyandu PN PRIMA

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Web-Based Apps PRIMAApps PRIMA (posyandu monitoring tools) is delivered using a web-based app accessible through web browsers with basic core functionalities	Device	Web-Based App
Apps PRIMA MobileEnhancement of Apps PRIMA delivered using a standalone mobile app. Enhanced core functionalities include the looping system of children measurements, automatic charts, and GEDSI-sensitive features	Device	Mobile + GEDSI Training, Mobile-Based App
Advance GEDSI TrainingAdditional training to address vulnerabilities in communities and empathetic service from CHWs to caregivers. The training is a follow-up training from a basic GEDSI materials already delivered to CHWs	Behavioural	Mobile + GEDSI Training

Primary outcome

At least one visitation completed
Time frame: From intervention roll-out to the end of intervention period in 6 months
The proportion of U5 children's visitation cycles in which CHWs completed at least the one required home visitation according to the app-generated schedule. For each cycle, a score of 1 is coded if the assigned CHW completes at least one visitation session within the scheduled time window, and 0 if none of the scheduled visitation was delivered. The final proportion is calculated as the number of cycles coded 1 in proportion to the total number of visitation cycles assigned to the CHW.

4 secondary outcomes

Proportion of on-time and completed visitation
Time frame: Every visitation conducted by CHW during the intervention period, marked by 6-month after the first use of app after training
Knowledge and Attitude of CHWs
Time frame: Measured in baseline (pre-intervention; maximum 1 months before training intervention) and endline (post-intervention; minimum 6 months intervention implementation)
Caregiver's knowledge and attitude
Time frame: Measured in baseline (pre-intervention; maximum 1 months before training intervention) and endline (post-intervention; minimum 6 months intervention implementation)
Caregiver's satisfaction on healthcare
Time frame: Measured in baseline (pre-intervention; maximum 1 months before training intervention) and endline (post-intervention; minimum 6 months intervention implementation)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

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?

At least one visitation completed (time frame: From intervention roll-out to the end of intervention period in 6 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 NCT07027384.

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 2 Jul 2026.