Case Management and Peer Support Groups for Prophylaxis Adherence in Rheumatic Heart Disease
- Conditions
- Rheumatic Heart Disease
- Interventions
- Behavioral: Case Manager and Peer Support Group
- Registration Number
- NCT05502042
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 209
- Ages 5-17
- New diagnosis of latent rheumatic heart disease (RHD) as determined through school screening -
- Medical contraindication to SAP (bleeding risk, allergy)
- Co-morbid conditions that have already resulted in prescription of SAP (typically HIV, sickle cell disease, renal disease)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peer Group + Case Manager Case Manager and Peer Support Group Usual care + an assigned village health team member to provide weekly short message (SMS) (weeks 1-3) and phone (week 4) support for attendance of SAP visits and a VHT (village health team member) led peer support group held at the assigned SAP clinic of participants, that includes games/peer support/education.
- Primary Outcome Measures
Name Time Method Secondary Prophylaxis Adherence 12 months Continuous adherence to intramuscular Benzathine penicillin, as determined by days of coverage (each injection = 28 days of coverage)
- Secondary Outcome Measures
Name Time Method Treatment satisfaction 6 months + 12 months 14-item Abbreviated Treatment Satisfaction Questionnaire (v 1.4)
Caregiver health-related quality of life enrollment, 6-months, 12-months Parent/caregiver module of the PedsQL 4.0
Patient health-related quality of life enrollment, 6-months, 12-months Pediatric Quality of Life Inventory Version 4.0 Generic Core (PedsQL 4.0) questionnaire
Trial Locations
- Locations (1)
Tororo Health Distric
🇺🇬Tororo, Uganda