Clinical trial NCT05502042: Case Management and Peer Support Groups for Prophylaxis Adherence in Rheumatic Heart Disease
Official title: Case Managers and Peer Support Groups (CAMPS) for Prophylaxis Adherence in Rheumatic Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatic Heart Disease
Keywords: adherence
clinical trial
community intervention
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Uganda Heart Institute
First posted: 2022-08-16
Enrollment: 209
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Secondary Prophylaxis Adherence
timeFrame: 12 months
Secondary outcomes:
measure: Treatment satisfaction
timeFrame: 6 months + 12 months
measure: Patient health-related quality of life
timeFrame: enrollment, 6-months, 12-months
measure: Caregiver health-related quality of life
timeFrame: enrollment, 6-months, 12-months
Other outcomes:
Locations:
city: Tororo
country: Uganda
facility: Tororo Health Distric
Study officials:
References: