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

Rheumatic Heart Disease Clinical Trial

— CAMPS  

Official title:

Case Managers and Peer Support Groups (CAMPS) for Prophylaxis Adherence in Rheumatic Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05502042
• Other study ID #: 2021-0789
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: September 1, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Heart Diseases
• Rheumatic Diseases
• Rheumatic Heart Disease

Intervention

Behavioral:
• Case 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.

Locations

Country	Name	City	State
Uganda	Tororo Health Distric	Tororo

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Uganda Heart Institute

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary Prophylaxis Adherence	Continuous adherence to intramuscular Benzathine penicillin, as determined by days of coverage (each injection = 28 days of coverage)	12 months
Secondary	Treatment satisfaction	14-item Abbreviated Treatment Satisfaction Questionnaire (v 1.4)	6 months + 12 months
Secondary	Patient health-related quality of life	Pediatric Quality of Life Inventory Version 4.0 Generic Core (PedsQL 4.0) questionnaire	enrollment, 6-months, 12-months
Secondary	Caregiver health-related quality of life	Parent/caregiver module of the PedsQL 4.0	enrollment, 6-months, 12-months