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

NCT05502042 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2024-01-18

No results posted yet for this study

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.

Conditions

  • Rheumatic Heart Disease

Interventions

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.

Sponsors & Collaborators

  • Uganda Heart Institute

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2023-08-09
Completion
2023-09-01

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05502042 on ClinicalTrials.gov