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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05504928
Acronym
NEPAL4
Enrollment
2300
Registered
2022-08-17
Start date
2022-06-01
Completion date
2026-12-01
Last updated
2022-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatic Heart Disease, Rheumatic Heart Disease in Children

Keywords

Rheumatic Heart Disease, Primary Prevention, Secondary Prevention, Screening

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.

Interventions

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.

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Interrupted time series design

Eligibility

Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of definite or borderline Rheumatic Heart Disease4 yearsPrevalence of definite or borderline Rheumatic Heart Disease according to the criteria of the World Heart Federation as assessed by systematic echocardiographic screening

Secondary

MeasureTime frameDescription
Group A β-hemolytic streptococcal pharyngitis4 yearsNumber of patients with group A β-hemolytic streptococcal pharyngitis within study participation
Acute rheumatic fever4 yearsNumber of patients with acute rheumatic fever within study participation
Rheumatic heart disease4 yearsNumber of patients with rheumatic heart disease within study participation
Adverse reactions to penicillin injections4 yearsNumber of patients with adverse reactions to penicillin injections within study participation

Countries

Nepal

Contacts

Primary ContactThomas Pilgrim, Prof. Dr.
kardio.studien@insel.ch0041316325000
Backup ContactKrishna Agrawal, Prof. Dr.
agrawalkris@gmail.com+977 985 7045721

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026