Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease (NEPAL4)
Primary Purpose
Rheumatic Heart Disease, Rheumatic Heart Disease in Children
Status
Recruiting
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
School nurse program
Sponsored by
About this trial
This is an interventional prevention trial for Rheumatic Heart Disease focused on measuring Rheumatic Heart Disease, Primary Prevention, Secondary Prevention, Screening
Eligibility Criteria
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.
Sites / Locations
- Tulsi Secondary Boarding SchoolRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: Implementation of a dedicated school nurse program
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Group A β-hemolytic streptococcal pharyngitis
Number of patients with group A β-hemolytic streptococcal pharyngitis within study participation
Acute rheumatic fever
Number of patients with acute rheumatic fever within study participation
Rheumatic heart disease
Number of patients with rheumatic heart disease within study participation
Adverse reactions to penicillin injections
Number of patients with adverse reactions to penicillin injections within study participation
Full Information
NCT ID
NCT05504928
First Posted
August 15, 2022
Last Updated
August 15, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT05504928
Brief Title
Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease
Acronym
NEPAL4
Official Title
Effectiveness of a School-centered Primary and Secondary Prevention Program on Prevalence of Latent Rheumatic Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Heart Disease, Rheumatic Heart Disease in Children
Keywords
Rheumatic Heart Disease, Primary Prevention, Secondary Prevention, Screening
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interrupted time series design
Masking
None (Open Label)
Allocation
N/A
Enrollment
2300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Implementation of a dedicated school nurse program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
School nurse program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of definite or borderline Rheumatic Heart Disease
Description
Prevalence of definite or borderline Rheumatic Heart Disease according to the criteria of the World Heart Federation as assessed by systematic echocardiographic screening
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Group A β-hemolytic streptococcal pharyngitis
Description
Number of patients with group A β-hemolytic streptococcal pharyngitis within study participation
Time Frame
4 years
Title
Acute rheumatic fever
Description
Number of patients with acute rheumatic fever within study participation
Time Frame
4 years
Title
Rheumatic heart disease
Description
Number of patients with rheumatic heart disease within study participation
Time Frame
4 years
Title
Adverse reactions to penicillin injections
Description
Number of patients with adverse reactions to penicillin injections within study participation
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Pilgrim, Prof. Dr.
Phone
0041316325000
Email
kardio.studien@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Krishna Agrawal, Prof. Dr.
Phone
+977 985 7045721
Email
agrawalkris@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Pilgrim, Prof. Dr.
Organizational Affiliation
Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulsi Secondary Boarding School
City
Tulsipur
ZIP/Postal Code
22412
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krishna Agrawal, Prof. Dr.
Phone
+9779857045721
Email
agrawalkris@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16253886
Citation
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.
Results Reference
background
PubMed Identifier
22405798
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.
Results Reference
background
PubMed Identifier
28834488
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.
Results Reference
background
PubMed Identifier
33206687
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.
Results Reference
background
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Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease
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