Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"

Rheumatic Heart Disease Clinical Trial

Official title:

Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05276999
• Other study ID #: 2021-0026
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine the impact of a pragmatic RHD primary prevention program in Uganda. The secondary Objective are as follow: 1. To improve guideline-based care for sore throat through frontline healthcare provider education on clinical decision rules and guideline-based primary prevention. 2. To increase health seeking behavior for sore throat thorough a multifaceted community awareness campaign.

Description:

Our intervention is designed as a service-oriented plan to be implemented through the primary healthcare structure and facilities of both the national health and private system. Additional support will come from the education system, with participation from schools, teachers, patients, patient families, and the public. Our intervention will focus on two of the more easily rectified impediments to primary prevention, namely (1) poor uptake of guideline-based treatments for Group A Streptococcal (GAS) pharyngitis and (2) low levels of public awareness of the importance of sore throat care and treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21740
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

• Has agreed to participate in the study via the study's informed consent/assent process.

Exclusion Criteria:

• Known history of ARF or RHD
• Any known co-morbid conditions (HIV, renal deficiencies, severe malnutrition,
• among others) that have resulted in prescription of regular antibiotic prophylaxis
• Structural or functional cardiac defects, other than those consistent with RHD, that were known prior to or detected through echo screening (except patent foramen ovale, small atrial septal defect, small ventricular septal defect, small patent ductus arteriosus).

Related Conditions & MeSH terms

• Heart Diseases
• Rheumatic Diseases
• Rheumatic Heart Disease

Intervention

Other:
• Healthcare provider education
Mix of training and educational activities within the district continuing medical education system targeting community health workers and frontline providers focused on the importance of sore throat and it's link to RHD, clinical guidelines to differentiate patients at high or low risk for GAS pharyngitis and guideline based care for treating GAS pharyngitis
• Community Awareness campaign
A district wide public health campaign to increase community awareness of sore throat, including school based education, VHT community sensitization, education of parents and patients, radio messaging, posters, signs and billboards.

Locations

Country	Name	City	State
Uganda	Uganda Heart Institute	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Children's National Research Institute, Uganda Heart Institute

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of Echocardiography prevalence of RHD among children 5-15 years old	Echocardiography screening of school age children in Uganda to determine prevalence of RHD prior to and 2 years post intervention	2 year endpoint