Currently submitted to: JMIR Research Protocols
Date Submitted: Jul 21, 2026
Open Peer Review Period: Jul 22, 2026 - Sep 16, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Comparing the effectiveness and cost-effectiveness of school-based versus school and community-based settings in echocardiogram screening for undetected rheumatic heart disease (RHD) for year 7 and 8 students in Aotearoa New Zealand: A protocol for a cluster randomised control trial.
ABSTRACT
Background:
Rheumatic heart disease (RHD) is a preventable condition that continues to disproportionately affect Māori and Pacific populations in Aotearoa. RHD often remains asymptomatic until valve disease is advanced, limiting opportunities for early intervention. Echocardiography (echo) enables detection of early, subclinical disease, however the effectiveness, cost-effectiveness and optimal delivery model for population-based RHD screening in Aotearoa remain uncertain. This study will generate high-quality data to inform future decisions regarding RHD echo screening.
Objective:
The primary objective is to determine the effectiveness and cost-effectiveness of echo screening for previously undetected RHD in school-based settings alone compared with school and community-based settings in Aotearoa, with a focus on designing a screening model that is culturally safe, acceptable and equity enhancing for Māori and Pacific populations.
Methods:
This is a cluster randomised control trial (RCT) with two intervention arms: (1) school-based echo screening, and (2), school- and community-based screening. Schools are the unit of randomisation. Approximately 32 schools (16 per arm) with an estimated 7,200 eligible Year 7 and 8 students (10 to 13 years) will be invited to participate, with an anticipated up to 2,800- students will be offered echo screening. Mixed-methods surveys will assess acceptability, experiences and preferences, as well as costs incurred by students’ families, schools, and community sites. Statistical analyses will be conducted for differences between study arms and key variables. Quantitative and qualitative findings will be evaluated using the RE-AIM 2.0 framework to evaluate programme effectiveness, implementation, cost-effectiveness, cultural acceptability and equity of the screening models for Māori and Pacific populations.
Results:
This study has received ethics approval (reference:2025 FULL 20445). Recruitment for schools and community sites commenced in March 2026 and is ongoing.
Conclusions:
Process and outcome evaluation findings from this cluster RCT study will provide knowledge and information on the effectiveness, cost-effectiveness and feasibility of an RHD echo screening programme for the Aotearoa context. Clinical Trial: Australian New Zealand Clinical Trials Registry (ACTRN12625000144415p); https://www.anzctr.org.au/
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