Effectiveness of an Integrated Program for the Prevention of Rheumatic Heart Disease in Endemic Regions: a Stepped Wedge Cluster Randomized Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rheumatic Heart Disease in Children
- Sponsor
- Thomas Pilgrim
- Enrollment
- 6000
- Primary Endpoint
- Rheumatic heart disease
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
The overall objective of the PREVENT trial is to evaluate the effectiveness of an integrated, school-based program for the prevention of rheumatic heart disease (RHD) in regions with an endemic pattern of RHD.
We conduct a stepped wedge cluster randomized trial in randomly selected schools in Nepal and Zambia.
The intervention will be delivered at the level of the school and consists in the introduction of a dedicated school-nurse program providing health care through education about RHD, assessment, intervention, and follow-up of GABHS pharyngitis, and facilitation of secondary antibiotic prophylaxis for children with RHD.
Investigators
Thomas Pilgrim
MD, MSc
Insel Gruppe AG, University Hospital Bern
Eligibility 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
Outcomes
Primary Outcomes
Rheumatic heart disease
Time Frame: The endpoint will be assessed after a minimum of 1 and a maximum of 3 years after introduction of the school nurse program.
The primary outcome of the study will be the reduction in prevalence of rheumatic heart disease according to WHF criteria 2023 as assessed by systematic echocardiographic screening.