Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Health Care for Children
Nutritional Status
Keywords: mHealth
decision-support tools
community health workers
primary health care
posyandu
Lead sponsor: Center for Indonesia's Strategic Development Initiatives
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 1030
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Completed follow-up home visits delivered as protocol
timeFrame: From intervention roll-out to the end of intervention period in 6 months
Secondary outcomes:
measure: First follow-up home visitations
timeFrame: From intervention roll-out to the end of intervention period in 6 months
measure: Knowledge and Attitude of CHWs
timeFrame: Measured in baseline (pre-intervention; maximum 1 months before training intervention) and endline (post-intervention; minimum 6 months intervention implementation)
measure: Caregiver's knowledge and attitude
timeFrame: Measured in baseline (pre-intervention; maximum 1 months before training intervention) and endline (post-intervention; minimum 6 months intervention implementation)
measure: Caregiver's satisfaction on healthcare
timeFrame: Measured in baseline (pre-intervention; maximum 1 months before training intervention) and endline (post-intervention; minimum 6 months intervention implementation)
Other outcomes:
measure: Feasibility on mHealth decision-support
timeFrame: Measured in endline (post-intervention) after 6 months
measure: Satisfaction on digital app
timeFrame: Measured in endline (post-intervention) after 6 months
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