Rheumatic Heart Disease
Conditions
Keywords
adherence, clinical trial, community intervention
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.
Interventions
BEHAVIORALCase Manager and Peer Support Group
Assignment of a Village health team member to provide support to the family through SMS messages (weeks 1-3) and phone call (week 4), as well as home visits as needed if no contacts are reached. These contacts are intended to provide encouragement and education to participants and families to encourage SAP and peer group attendance. Peer groups will have simple play and support activities, led by the village health team member, to improve the experience of SAP for the participating children.
Sponsors
Uganda Heart Institute
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Our primary outcome, adherence to SAP, will be abstracted from copies of final Uganda Ministry of Health SAP booklets by a team member blinded to treatment allocation.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Ages 5-17 2. New diagnosis of latent rheumatic heart disease (RHD) as determined through school screening -
Exclusion criteria
1. Medical contraindication to SAP (bleeding risk, allergy) 2. Co-morbid conditions that have already resulted in prescription of SAP (typically HIV, sickle cell disease, renal disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Prophylaxis Adherence | 12 months | Continuous adherence to intramuscular Benzathine penicillin, as determined by days of coverage (each injection = 28 days of coverage) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment satisfaction | 6 months + 12 months | 14-item Abbreviated Treatment Satisfaction Questionnaire (v 1.4) |
| 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 |
| Caregiver health-related quality of life | enrollment, 6-months, 12-months | Parent/caregiver module of the PedsQL 4.0 |
Countries
Uganda
Outcome results
None listed