Championing hypertension remote monitoring for equity and dissemination (CHARMED): A multi-site factorial randomized controlled trial protocol

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2025-05-01 Epub Date: 2025-03-12 DOI:10.1016/j.cct.2025.107879

Courtney R. Lyles , Elaine C. Khoong , Rachel J. Stern , Nooshin Abtahi , Anjana E. Sharma , Mark J. Pletcher , Fan Xia , Faviola Garcia , Nilpa D. Shah , Lina Tieu , Urmimala Sarkar , the CHARMED consortium

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Abstract

Introduction

We have evidence-based strategies such as remote patient monitoring and digital health tools to improve hypertension outcomes. Still, we lack large-scale studies focusing on disseminating these practices into routine clinical care. This is especially important to study within safety-net healthcare settings that disproportionately care for marginalized patient populations.

Methods

We will conduct a hybrid type 1 implementation trial (2 × 2 factorial design) with 25 safety-net clinics across three of California's public healthcare delivery systems, enrolling 2500 English- and Spanish-speaking patients with uncontrolled hypertension. Clinics will be randomized to receive baseline training on best practices in remote monitoring for hypertension management vs. training plus ongoing practice facilitation to support its implementation. Patients within these clinics will be randomized to receive cellular-enabled blood pressure monitors and automatic text message reminders to check their blood pressure at home vs. receipt of the same monitors as well as additional support via individually tailored text message feedback and support for hypertension management.

Results

The primary outcome will be a change in systolic blood pressure collected during routine office visits. Secondary outcomes include changes in home blood pressure and patient-reported assessments of clinical care and medication adherence. Given the hybrid type I trial implementation, the primary implementation outcomes will be the adoption of intervention at the patient and clinic levels.

Discussion

The evidence from this trial will advance implementation-focused research on hypertension management, such as the essential combination of both patient- and clinic-facing intervention strategies.

Trial Registration

NCT, NCT06113458. Registered 23 October 2023, https://clinicaltrials.gov/study/NCT06113458

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支持高血压远程监测，促进公平和推广（CHARMED）：多地点因子随机对照试验方案。

我们有基于证据的策略，如远程患者监测和数字健康工具来改善高血压预后。然而，我们仍然缺乏大规模的研究，将这些实践推广到常规临床护理中。这对于在不成比例地照顾边缘化患者群体的安全网医疗保健环境中进行研究尤其重要。方法：我们将进行一项混合型1型实施试验（2 × 2因子设计），在加州三个公共医疗保健提供系统的25个安全网诊所中，招募2500名英语和西班牙语不受控制的高血压患者。诊所将随机接受关于高血压管理远程监测最佳实践的基线培训，而不是培训加持续实践促进以支持其实施。这些诊所的患者将被随机分配到具有蜂窝功能的血压监测仪和自动短信提醒，以在家中检查他们的血压，并收到相同的监测仪，以及通过个性化定制的短信反馈和高血压管理支持的额外支持。结果：主要结果将是在常规办公室就诊时收集的收缩压的变化。次要结果包括家庭血压的变化和患者报告的临床护理和药物依从性评估。考虑到混合I型试验的实施，主要的实施结果将是在患者和诊所层面采取干预措施。讨论：来自该试验的证据将推进以实施为重点的高血压管理研究，例如患者和临床干预策略的基本结合。试验注册：NCT， NCT06113458。2023年10月23日注册，网址：https://clinicaltrials.gov/study/NCT06113458。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.