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

January 16, 2024 updated by: Sarah deLoizaga Carney, Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Tororo, Uganda
        • Tororo Health Distric

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Referral to a health facility (HC III, IV, or district hospital) that provide secondary antibiotic prophylaxis (every-28-day intramuscular benzathine benzylpenicillin G, BPG), receipt of a Ministry of Health secondary prophylaxis adherence booklet, and education for patient and family about the importance of SAP.
Experimental: Peer Group + Case Manager
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Prophylaxis Adherence
Time Frame: 12 months
Continuous adherence to intramuscular Benzathine penicillin, as determined by days of coverage (each injection = 28 days of coverage)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment satisfaction
Time Frame: 6 months + 12 months
14-item Abbreviated Treatment Satisfaction Questionnaire (v 1.4)
6 months + 12 months
Patient health-related quality of life
Time Frame: enrollment, 6-months, 12-months
Pediatric Quality of Life Inventory Version 4.0 Generic Core (PedsQL 4.0) questionnaire
enrollment, 6-months, 12-months
Caregiver health-related quality of life
Time Frame: enrollment, 6-months, 12-months
Parent/caregiver module of the PedsQL 4.0
enrollment, 6-months, 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Uganda Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Actual)

August 9, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

August 12, 2022

First Submitted That Met QC Criteria

August 12, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0789

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data will be available to other investigators on reasonable request after publication of the primary results.

IPD Sharing Time Frame

After publication of the primary study results (anticipated December 2024)

IPD Sharing Access Criteria

Reasonable request for related research

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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