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

Rheumatic Heart Disease Clinical Trial

— NEPAL4  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504928
• Other study ID #: NEPAL4
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: August 2022
• Source: University Hospital Inselspital, Berne
• Contact: Thomas Pilgrim, Prof. Dr.
• Phone: 0041316325000
• Email: kardio.studien[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: December 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases
• Rheumatic Diseases
• Rheumatic Heart Disease
• Rheumatic Heart Disease in Children

Intervention

Other:
• School nurse program
School nurse program providing health care through assessment, intervention and follow-up of group A ß-hemolytic streptococcal pharyngitis and facilitation of secondary antibiotic prophylaxis for children with latent rheumatic heart disease.

Locations

Country	Name	City	State
Nepal	Tulsi Secondary Boarding School	Tulsipur

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Nepal, 

References & Publications (4)

Carapetis JR, Steer AC, Mulholland EK, Weber M. The global burden of group A streptococcal diseases. Lancet Infect Dis. 2005 Nov;5(11):685-94. Review. — View Citation

Marijon E, Mirabel M, Celermajer DS, Jouven X. Rheumatic heart disease. Lancet. 2012 Mar 10;379(9819):953-964. doi: 10.1016/S0140-6736(11)61171-9. Review. — View Citation

Pearce S, Bowen AC, Engel ME, de la Lande M, Barth DD. The incidence of sore throat and group A streptococcal pharyngitis in children at high risk of developing acute rheumatic fever: A systematic review and meta-analysis. PLoS One. 2020 Nov 18;15(11):e0242107. doi: 10.1371/journal.pone.0242107. eCollection 2020. — View Citation

Watkins DA, Johnson CO, Colquhoun SM, Karthikeyan G, Beaton A, Bukhman G, Forouzanfar MH, Longenecker CT, Mayosi BM, Mensah GA, Nascimento BR, Ribeiro ALP, Sable CA, Steer AC, Naghavi M, Mokdad AH, Murray CJL, Vos T, Carapetis JR, Roth GA. Global, Regional, and National Burden of Rheumatic Heart Disease, 1990-2015. N Engl J Med. 2017 Aug 24;377(8):713-722. doi: 10.1056/NEJMoa1603693. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of definite or borderline Rheumatic Heart Disease	Prevalence of definite or borderline Rheumatic Heart Disease according to the criteria of the World Heart Federation as assessed by systematic echocardiographic screening	4 years
Secondary	Group A ß-hemolytic streptococcal pharyngitis	Number of patients with group A ß-hemolytic streptococcal pharyngitis within study participation	4 years
Secondary	Acute rheumatic fever	Number of patients with acute rheumatic fever within study participation	4 years
Secondary	Rheumatic heart disease	Number of patients with rheumatic heart disease within study participation	4 years
Secondary	Adverse reactions to penicillin injections	Number of patients with adverse reactions to penicillin injections within study participation	4 years