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

NCT07027384 | Active Not Recruiting

• 2 other identifiers: koneksiRCT1447/CRG/2024/46-CISDI
• Study Type: interventional
• Target: 1,030
• Locations: 1 country
• Sites: 6

Brief Summary

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

Nutritional Status; Primary Health Care for Children

Keywords

mHealth; decision-support tools; community health workers; primary health care; posyandu

Outcome Measures

Primary Outcomes (1)

• 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.

  From intervention roll-out to the end of intervention period in 6 months

Secondary Outcomes (4)

• Proportion of on-time and completed visitation

  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

  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

  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

  Measured in baseline (pre-intervention; maximum 1 months before training intervention) and endline (post-intervention; minimum 6 months intervention implementation)

Other Outcomes (2)

• Feasibility on mHealth decision-support

  Measured in endline (post-intervention) after 6 months

• Satisfaction on digital app

  Measured in endline (post-intervention) after 6 months

Study Arms (3)

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

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).

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.

Device: Apps PRIMA Mobile; Behavioral: Advance GEDSI Training

Interventions

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

Web-Based App

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

Mobile + GEDSI Training; Mobile-Based App

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

Mobile + GEDSI Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Community Health Workers working outside of Posyandu PN PRIMA

Sponsors & Collaborators

• Center for Indonesia's Strategic Development Initiatives: lead

Study Sites (6)

Puskesmas Sukmajaya

Depok, West Java, 16411, Indonesia

Location

Puskesmas Abadijaya

Depok, Indonesia

Location

Puskesmas Baktijaya

Depok, Indonesia

Location

Puskesmas Cinangka

Depok, Indonesia

Location

Puskesmas Limo

Depok, Indonesia

Location

Puskesmas Sukatani

Depok, Indonesia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 18, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

ID (6)