NCT07065474

Effectiveness of Edutainment-Based Interventions in Increasing Knowledge of Rheumatic Fever and Rheumatic Heart Disease Among School-Going Children in Nepal: Study Protocol for Colors to Save Hearts Quasi-Experimental Pretest-Posttest Study

Not yet recruiting NA Last updated 15 July 2025

What this trial tests

NA trial testing education material in Rheumatic Heart Disease in 2,400 participants. Not yet recruiting.

Timeline

28 July 2025

Primary endpoint
3 October 2025

12 November 2025

Quick facts

Lead sponsor	Kathmandu Institute of Child Health
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	2,400
Start date	28 July 2025
Primary completion	3 October 2025
Estimated completion	12 November 2025
Sites	1 location across Nepal

Drugs / interventions tested

• education material

Conditions studied

• Rheumatic Heart Disease — all drugs for Rheumatic Heart Disease →

Sponsor

Kathmandu Institute of Child Health

Who can join

Adults 10 to 18, any sex, with Rheumatic Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Acute rheumatic fever (ARF) and its sequela, rheumatic heart disease (RHD), remain significant public health concerns in low- and middle-income countries, including Nepal. Despite their preventable nature, awareness of ARF and RHD among schoolchildren is limited. Innovative, age-appropriate health education strategies are urgently needed to promote early recognition and prevention.

Objective: This study aims to evaluate the effectiveness of an edutainment-based intervention in improving knowledge of ARF and RHD among school-going children in Nepal.

Methods: A quasi-experimental pretest-posttest study design with a waitlist control group will be employed across 24 public schools in six diverse districts. A total of 2,400 students from Grades 6 to 9 will be included. The intervention integrates creative educational tools-coloring books, activity books, storytelling, videos, and interactive sessions-tailored to different age groups. Knowledge change will be measured using a validated questionnaire administered at baseline and post-intervention. Secondary outcomes include the prevalence of RHD-related symptoms assessed through clinical screening.

Expected Outcomes: It is hypothesized that students in the intervention group will demonstrate a statistically significant improvement in knowledge scores compared to their baseline levels and the control group. The study will also assess the feasibility and acceptability of the intervention and inform recommendations for broader school-based health education programs.

Conclusion: This study addresses a critical gap in child health education in Nepal using an innovative, scalable approach. Findings will contribute to the evidence base for integrating edutainment into school curricula to combat preventable diseases like RHD in resource-limited settings.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Measuring Children's Knowledge of Acute Rheumatic Fever and Rheumatic Heart Disease: Development and Validation of RHD Knowledge Scale in Nepal.
   Karki S, Paudel S, Hada RP, Khadka P, et al · · 2025 · PMID 41408758 · DOI 10.1177/00469580251405997