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

NCT07065474 | Not Yet Recruiting DMC

• 1 other identifier: Color to Save Hearts- KIOCH
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatic Heart Disease

Keywords

Colour to Save Hearts; Rheumatic heart disease; Rheumatic Fever; Health awarness; Youth intervention

Outcome Measures

Primary Outcomes (1)

• Change in knowledge about ARF and RHD

  The primary outcome of the study is the change in knowledge about ARF and RHD among schoolchildren, assessed using a structured questionnaire administered at two time points: baseline (pretest) and end line (posttest). The knowledge will be assessed by the tool developed by the research team were the knowledge scale comprises 14 single-best-answer multiple-choice questions. Each correct response is assigned a score of one, while incorrect and "don't know" responses receive a score of zero. The total knowledge score ranges from 0 to 14, with higher scores indicating better knowledge about ARF and RHD.

  3 months

Study Arms (2)

In the intervention group, students will be exposed to the full package of educational materials

EXPERIMENTAL

Grades 6 to 7 Coloring Book With two components: * Stories * Coloring Assignments • Narratives designed to explain key concepts related to RHD • Activities based on the stories to reinforce learning. Video session • Students will watch educational videos containing information about ARF and RHD, its symptoms, prevention, control, management and treatment. Classroom interactive sessions • Discussion and activities designed to engage students and clarify their understanding on ARF and EHD Grades 8 to 9 Activity book With two components: * Heart Coloring Assignments * Games • Heart coloring assignments aims to familiarize participants with the basic structure of human heart • Games includes puzzles, scrambled words, maze run with content on RHD awareness to engaged participants Video session • Students will be exposed to video contain with information regarding ARF and RHD, its symptoms, prevention, control, management and treatment

Other: education material

Control group

NO INTERVENTION

No intervention will be applied

Interventions

education material OTHER

For students in Grades 6 to 7, the intervention comprises a coloring book that integrates storytelling and coloring assignments designed to explain key concepts related to ARF and RHD. In addition, students in these grades will watch video sessions that cover the symptoms, causes, prevention, and treatment of ARF and RHD. These videos serve to visualize the information introduced in the books. Complementing these materials, the intervention includes interactive classroom sessions facilitated by the trained field team, during which students will participate in guided discussions and activities to enhance their understanding and retention of health messages. For students in Grades 8 to 9, the intervention uses a more advanced format tailored to older adolescents. These students will receive an activity book that includes heart anatomy coloring assignments and games such as puzzles, scrambled words, and maze runs that incorporate facts and concepts about RHD.

In the intervention group, students will be exposed to the full package of educational materials

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Students will be excluded from the study if they or their guardians decline to participate or fail to provide the required consent and assent. Students who are absent during both the baseline and post-intervention assessments will also be excluded from the final analysis.

Sponsors & Collaborators

• Kathmandu Institute of Child Health: lead

Study Sites (1)

Kathmandu Institute of Child Health

Kathmandu, Bagmati, 44600, Nepal

Location

MeSH Terms

Conditions

Rheumatic Heart Disease; Rheumatic Fever

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dr. Sandeepa Karki, MD Community Medicine

  Kathmandu Institute of Child Health

  PRINCIPAL INVESTIGATOR

• Mr. Dhurba Khatri, MPH

  Kathmandu Institute of Child Health

  PRINCIPAL INVESTIGATOR

• Mr. Shishir Paudel, MPH

  Kathmandu Institute of Child Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Sandeepa Karki, MD Community Medicine

CONTACT

+9779860621774; sandeepa@kioch.org.np

Mr. Shishir Paudel, MPH

CONTACT

+9779846756100; shishirpaudel11@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Monitoring, Evaluation, Accountability, and Learning Officer

Model Details: This study will employ a quasi-experimental pretest-posttest design with a waitlist control group to evaluate the effectiveness of an edutainment-based educational intervention aimed at increasing knowledge about ARF and RHD among school-going children. The design allows for comparisons between the intervention and control groups while ensuring ethical considerations through eventual intervention delivery to all participants.

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 15, 2025
• Study Start: July 28, 2025
• Primary Completion: October 3, 2025
• Study Completion: November 12, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)