Case Management and Peer Support Groups for Prophylaxis Adherence in Rheumatic Heart Disease
Condition: Rheumatic Heart Disease
MeSH terms: Rheumatic Heart Disease; Rheumatic Diseases; Heart Diseases
Study type: Interventional

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.
    

Intervention name(s): Case Manager and Peer Support Group
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: adherence; clinical trial; community intervention