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临床试验/NCT05502042
NCT05502042已完成不适用

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

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2022年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
209
试验地点
1
主要终点
Secondary Prophylaxis Adherence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Our primary outcome, adherence to SAP, will be abstracted from copies of final Uganda Ministry of Health SAP booklets by a team member blinded to treatment allocation.

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • New diagnosis of latent rheumatic heart disease (RHD) as determined through school screening -

排除标准

  • Medical contraindication to SAP (bleeding risk, allergy)
  • Co-morbid conditions that have already resulted in prescription of SAP (typically HIV, sickle cell disease, renal disease)

结局指标

主要结局

Secondary Prophylaxis Adherence

时间窗: 12 months

Continuous adherence to intramuscular Benzathine penicillin, as determined by days of coverage (each injection = 28 days of coverage)

次要结局

  • Patient health-related quality of life(enrollment, 6-months, 12-months)
  • Treatment satisfaction(6 months + 12 months)
  • Caregiver health-related quality of life(enrollment, 6-months, 12-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah deLoizaga Carney

Instructor, Pediatrics

Children's Hospital Medical Center, Cincinnati

研究点 (1)

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