Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease

Not Applicable

Recruiting

• Conditions: Rheumatic Heart Disease; Rheumatic Heart Disease in Children
• Interventions: Other: School nurse program

• Registration Number: NCT05504928
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

The overall objective is to evaluate the effectiveness of a school-centered primary and secondary prevention program on the prevalence of latent rheumatic heart disease among schoolchildren in Nepal, and to investigate the role of socioeconomic and environmental factors in the development and progression of rheumatic heart disease.

Detailed Description

Three in four children worldwide grow up in regions of the world where patterns of acute rheumatic fever and rheumatic heart disease are endemic and where rheumatic heart disease accounts for \>300'000 deaths every year. Evidence from a systematic review and meta-analysis of 10 studies indicated an incidence of group A β-hemolytic streptococcal (GAHBS) pharyngitis among children in low- to upper-middle income countries of 10.8 per 100 child-years with considerable heterogeneity between individual reports.

Timely detection of GAHBS pharyngitis by use of rapid antigen detection tests and initiation of antibiotic treatment represents an effective target for primary prevention. Early stages of rheumatic heart disease manifest with morphologic or functional valvular changes that can only be detected with echocardiography and are therefore latent. Latent stages of rheumatic heart disease are reversible with timely initiation of secondary antibiotic prophylaxis. A school-centered approach provides an opportunity to provide equitable access to a primary and secondary prophylaxis program with the potential to substantially reduce the burden of rheumatic heart disease in endemic regions.

All children 5-16 years of age from Tulsi Secondary Boarding School in Tulsipur, Nepal, will be eligible for inclusion. Sociodemographic characteristics and will be collected by means of a standardized interview. In a study using an interrupted time series design, prevalence of latent rheumatic heart disease will be measured by means of transthoracic echocardiography before, and two and four years after implementation of a dedicated school nurse program providing health care through assessment, intervention and follow-up of GAHBS pharyngitis and facilitation of secondary antibiotic prophylaxis for children with latent rheumatic heart disease.

Investigators expect to find a decrease in prevalence of rheumatic heart disease after implementation of a dedicated school-centered prevention program primarily led by school nurses, and to identify sociodemographic and environmental factors associated with the development and progression of rheumatic heart disease.

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Last Update Submitted: 2022-08-15
• Study First Posted: 2022-08-17
• Last Update Posted: 2022-08-17
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2300

Inclusion Criteria

• Age 5-16 years
• Attending Tulsi Secondary Boarding School in Tulsipur, Nepal.

Exclusion Criteria

• Children / primary caregivers not providing informed consent to participate
• Children not attending Tulsi Secondary Boarding School in Tulsipur.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Implementation of a dedicated school nurse program	School nurse program	School nurse program providing health care through assessment, intervention and follow-up of group A β-hemolytic streptococcal pharyngitis and facilitation of secondary antibiotic prophylaxis for children with latent rheumatic heart disease.

Primary Outcome Measures

Name	Time	Method
Prevalence of definite or borderline Rheumatic Heart Disease	4 years	Prevalence of definite or borderline Rheumatic Heart Disease according to the criteria of the World Heart Federation as assessed by systematic echocardiographic screening

Secondary Outcome Measures

Name	Time	Method
Acute rheumatic fever	4 years	Number of patients with acute rheumatic fever within study participation
Group A β-hemolytic streptococcal pharyngitis	4 years	Number of patients with group A β-hemolytic streptococcal pharyngitis within study participation
Rheumatic heart disease	4 years	Number of patients with rheumatic heart disease within study participation
Adverse reactions to penicillin injections	4 years	Number of patients with adverse reactions to penicillin injections within study participation

Trial Locations

Locations (1)

Tulsi Secondary Boarding School; 🇳🇵 Tulsipur, Nepal