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

NCT05504928 | Recruiting

• 1 other identifier: NEPAL4
• Study Type: interventional
• Target: 2,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatic Heart Disease; Rheumatic Heart Disease in Children

Keywords

Rheumatic Heart Disease; Primary Prevention; Secondary Prevention; Screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Group A β-hemolytic streptococcal pharyngitis

  4 years

• Acute rheumatic fever

  4 years

• Rheumatic heart disease

  4 years

• Adverse reactions to penicillin injections

  4 years

Study Arms (1)

Experimental: Implementation of a dedicated school nurse program

EXPERIMENTAL

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.

Other: School nurse program

Interventions

School nurse program OTHER

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.

Experimental: Implementation of a dedicated school nurse program

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 5-16 years
• Attending Tulsi Secondary Boarding School in Tulsipur, Nepal.

You may not qualify if:

• Children / primary caregivers not providing informed consent to participate
• Children not attending Tulsi Secondary Boarding School in Tulsipur.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Tulsi Secondary Boarding School

Tulsi̇̄pur, 22412, Nepal

RECRUITING

Related 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. doi: 10.1016/S1473-3099(05)70267-X.

  PMID: 16253886 BACKGROUND

• 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.

  PMID: 22405798 BACKGROUND

• 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.

  PMID: 28834488 BACKGROUND

• 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.

  PMID: 33206687 BACKGROUND

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases

Study Officials

• Thomas Pilgrim, Prof. Dr.

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Pilgrim, Prof. Dr.

CONTACT

0041316325000; kardio.studien@insel.ch

Krishna Agrawal, Prof. Dr.

CONTACT

+977 985 7045721; agrawalkris@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interrupted time series design

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)