Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease (NEPAL4)

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Rheumatic Heart Disease; Rheumatic Heart Disease in Children

Treatments: Other: School nurse program

Study type: Interventional

Funder types: Other

Identifiers

NCT05504928

NEPAL4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,300 estimated patients

Sex: All

Ages: 5 to 16 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,300 participants in 1 patient group

Experimental: Implementation of a dedicated school nurse program

Experimental group

Description:

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.

Treatment:

Other: School nurse program