- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07027384
- Original Trial
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 (KSI-RCT)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Depok, Indonesia
- Puskesmas Abadijaya
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Depok, Indonesia
- Puskesmas Baktijaya
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Depok, Indonesia
- Puskesmas Cinangka
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Depok, Indonesia
- Puskesmas Limo
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Depok, Indonesia
- Puskesmas Sukatani
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West Java
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Depok, West Java, Indonesia, 16411
- Puskesmas Sukmajaya
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Web-Based App
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
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Apps PRIMA (posyandu monitoring tools) is delivered using a web-based app accessible through web browsers with basic core functionalities
|
|
Experimental: Mobile-Based App
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).
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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
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Experimental: Mobile + GEDSI Training
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.
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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
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
At least one visitation completed
Time Frame: From intervention roll-out to the end of intervention period in 6 months
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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Kader's knowledge on children's nutritional needs and status, and attitudes toward vulnerable population
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Measured in baseline (pre-intervention; maximum 1 months before training intervention) and endline (post-intervention; minimum 6 months intervention implementation)
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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)
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Parents/caregivers knowledge on children's nutrition and primary care services, and attitudes towards primary healthcare services
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Measured in baseline (pre-intervention; maximum 1 months before training intervention) and endline (post-intervention; minimum 6 months intervention implementation)
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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)
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Parents/caregivers satisfaction towards primary healthcare services
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Measured in baseline (pre-intervention; maximum 1 months before training intervention) and endline (post-intervention; minimum 6 months intervention implementation)
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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
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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.
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Every visitation conducted by CHW during the intervention period, marked by 6-month after the first use of app after training
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility on mHealth decision-support
Time Frame: Measured in endline (post-intervention) after 6 months
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Perception of feasibility and usability of apps PRIMA from Kader
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Measured in endline (post-intervention) after 6 months
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Satisfaction on digital app
Time Frame: Measured in endline (post-intervention) after 6 months
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Satisfaction of digital app (apps PRIMA) by Kader
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Measured in endline (post-intervention) after 6 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- koneksiRCT
- 1447/CRG/2024/46-CISDI (Other Grant/Funding Number: KONEKSI)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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