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Completed

NCT Number: NCT07027384

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Puskesmas Sukmajaya, Depok, West Java, Indonesia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Community Health Workers working outside of Posyandu PN PRIMA

Treatment and study plan

Web-Based Apps PRIMA

Device

Apps PRIMA (posyandu monitoring tools) is delivered using a web-based app accessible through web browsers with basic core functionalities

Apps PRIMA Mobile

Device

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 Training

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. 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)

    Kader's knowledge on children's nutritional needs and status, and attitudes toward vulnerable population

  3. 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)

    Parents/caregivers knowledge on children's nutrition and primary care services, and attitudes towards primary healthcare services

  4. 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)

    Parents/caregivers satisfaction towards primary healthcare services

Other outcomes

  1. Feasibility on mHealth decision-support

    Time frame: Measured in endline (post-intervention) after 6 months

    Perception of feasibility and usability of apps PRIMA from Kader

  2. Satisfaction on digital app

    Time frame: Measured in endline (post-intervention) after 6 months

    Satisfaction of digital app (apps PRIMA) by Kader

Sponsors and collaborators

Lead sponsor

Center for Indonesia's Strategic Development Initiatives

Other

Registry information

Acronym: KSI-RCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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