Case Management & Peer Support Groups for Prophylaxis Adherence in

Status Completed

Clinical Trial Summary

The objective of CAMPS is to test and evaluate scalable models of secondary antibiotic adherence support for children newly diagnosed with rheumatic heart disease. Aim 1: Determine 1-year BPG adherence rates of children newly diagnosed with latent RHD in Uganda randomized to two support strategies: (1) Usual care (Arm 1) (2) peer group + case manager strategy (Arm 2). Aim 2: Explore patient reported outcomes including treatment satisfaction, patient health-related quality of life, and care giver quality of life, in relation to support strategy and adherence.

Clinical Trial Description

While significant strides have been made in echo screening for early detection of RHD and establishment of RHD registries, these efforts are diluted by poor adherence to secondary antibiotic prophylaxis (SAP). In a systematic review by Kevat et al which included 20 global programs, only 20% were able to maintain patients on at least 80% adherence (the minimum acceptable level). Other studies demonstrate similar findings, with adherence ranging from as low as 20% up to 75%. These studies demonstrate that non-adherence undermines most global SAP programs. Despite low adherence to RHD secondary prophylaxis globally, studies have demonstrated that ideal RHD SAP adherence can be achieved, but within the confines of strict trial conditions (GOAL Trial). Currently, there is a dearth of research into pragmatic, scalable approaches to improve RHD SAP adherence. In their systematic review of effectiveness and integration of RHD prevention and control programs, Abrams et. al. advise that prevention and treatment programs should be integrated into general health systems and strengthen local systems. Case Managers and Peer Support Groups (CAMPS) will be a pragmatic randomized trial of two support strategies for rheumatic heart disease secondary antibiotic prophylaxis, integrated into routine care. Hence, CAMPS will address the gap that exists between ideal adherence achieved within the confines of a strict research trial and practical and scalable solutions that can be translated to real-world settings. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05502042
Study type	Interventional
Source	Children's Hospital Medical Center, Cincinnati
Contact
Status	Completed
Phase	N/A
Start date	August 15, 2022
Completion date	September 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05991219` - Screening and Secondary Prevention Rheumatic Heart Disease Study
Completed	`NCT02661763` - Rheumatic Heart Disease Study in Lusaka	N/A
Completed	`NCT02188862` - Genetic Susceptibility to Rheumatic Heart Disease in the Pacific Region	N/A
Completed	`NCT01178710` - Effect of Simvastatin on Cardiac Function	N/A
Recruiting	`NCT05693545` - GOALIE: Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent RHD Trial	Phase 2
Completed	`NCT06150274` - Comparison of Wire Assisted Percutaneous Balloon Mitral Valvulotomy With Standard Inoue Balloon Valvulotomy	N/A
Terminated	`NCT03926156` - RIvoraxaban in Mitral Stenosis	Phase 3
Recruiting	`NCT05783375` - Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda	N/A
Completed	`NCT02474108` - Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion and Left Atrium Enlargement	N/A
Recruiting	`NCT04556188` - The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa
Recruiting	`NCT03991910` - The Effect of Ramipril in Suppressing ST2 Expression in Rheumatic Mitral Stenosis Patients	Phase 3
Active, not recruiting	`NCT03346525` - Determining the Impact of Penicillin in Latent RHD: The GOAL Trial	Phase 2
Recruiting	`NCT05504928` - Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease	N/A
Not yet recruiting	`NCT03549052` - Right Ventricular Echo Assessment in Mitral Valve Replacement
Recruiting	`NCT05487469` - Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass	N/A
Completed	`NCT05276999` - Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"	N/A
Completed	`NCT05668611` - Train the Trainer Curriculum to Scale up AI Supported Echo for RHD Screening in a Public Health System	N/A
Active, not recruiting	`NCT05211024` - A Long-term Follow up Study for Patients Who Participated in the GOAL Trial (GOAL-Post)
Withdrawn	`NCT02832531` - INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Superiority	Phase 3
Completed	`NCT01794884` - Validity Study of Glutamine to Improve Cardiac Function in Cardiac Surgery	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Case Management and Peer Support Groups for Prophylaxis Adherence in Rheumatic Heart Disease — CAMPS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms