Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease
NCT ID: NCT05504928
Last Updated: 2022-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2300 participants
INTERVENTIONAL
2022-06-01
2026-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Experimental: Implementation of a dedicated 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Attending Tulsi Secondary Boarding School in Tulsipur, Nepal.
Exclusion Criteria
* Children not attending Tulsi Secondary Boarding School in Tulsipur.
5 Years
16 Years
ALL
Yes
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Thomas Pilgrim, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Bern University Hospital
Locations
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Tulsi Secondary Boarding School
Tulsi̇̄pur, , Nepal
Countries
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Central Contacts
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Facility Contacts
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References
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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. doi: 10.1016/S1473-3099(05)70267-X.
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.
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.
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.
Other Identifiers
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NEPAL4
Identifier Type: -
Identifier Source: org_study_id
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