School-based program to prevent rheumatic heart disease in children in endemic regions
Effectiveness of an Integrated Program for the Prevention of Rheumatic Heart Disease in Endemic Regions: a Stepped Wedge Cluster Randomized Trial
NA · Insel Gruppe AG, University Hospital Bern · NCT06720272
The program will try to prevent rheumatic heart disease in schoolchildren aged 5–16 by placing trained nurses in schools to teach about strep throat, provide assessment and treatment, and help ensure ongoing antibiotic prevention for those at risk.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 6000 (estimated) |
| Ages | 5 Years to 16 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 2 sites (Kathmandu and 1 other locations) |
| Trial ID | NCT06720272 on ClinicalTrials.gov |
What this trial studies
This stepped-wedge cluster randomized trial introduces a dedicated school-nurse program in randomly selected schools in Nepal and Zambia. The school-level intervention provides education about rheumatic heart disease, assessment and management of group A streptococcal pharyngitis, and facilitation of secondary antibiotic prophylaxis for children with RHD. Schools crossover from usual care to the nurse-led program in a randomized sequence, permitting comparison over time and across sites. The trial enrolls children aged 5–16 who attend participating schools with caregiver consent.
Who should consider this trial
Good fit: Ideal candidates are children aged 5–16 who attend one of the selected participating schools in the trial and whose caregivers provide informed consent.
Not a fit: Children who do not attend the selected schools, whose caregivers do not consent, or who already have advanced, irreversible valve damage are unlikely to benefit from the intervention.
Why it matters
Potential benefit: If successful, the program could reduce new cases and progression of rheumatic heart disease by improving early detection, timely treatment of strep throat, and adherence to antibiotic prophylaxis.
How similar studies have performed: Previous school-based screening and antibiotic prophylaxis programs have shown benefits in endemic areas, though randomized stepped-wedge evaluations of nurse-led school programs are relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Children aged 5-16 years Exclusion Criteria: * Children / primary caregivers not providing informed consent to participate * Children not attending one of the selected schools
Where this trial is running
Kathmandu and 1 other locations
- National Academy od Medical Sciences — Kathmandu, Nepal (RECRUITING)
- Centre of Infectious Disease Research — Lusaka, Zambia (RECRUITING)
Study contacts
- Study coordinator: Thomas Pilgrim Bern University Hospital, Bern, Switzerland
- Email: thomas.pilgrim@insel.ch
- Phone: +41 31 632 08 27
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rheumatic Heart Disease in Children, rheumatic heart disease, valvular heart disease, prevention, streptococcal pharyngitis, rheumatic fever