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。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub 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

{"title":"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。","authors":"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","doi":"10.1016/j.cct.2025.107879","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Discussion</h3><div>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.</div></div><div><h3>Trial Registration</h3><div>NCT, <span><span>NCT06113458</span><svg><path></path></svg></span>. Registered 23 October 2023, <span><span>https://clinicaltrials.gov/study/NCT06113458</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107879"},"PeriodicalIF":2.0000,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Championing hypertension remote monitoring for equity and dissemination (CHARMED): A multi-site factorial randomized controlled trial protocol\",\"authors\":\"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\",\"doi\":\"10.1016/j.cct.2025.107879\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Discussion</h3><div>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.</div></div><div><h3>Trial Registration</h3><div>NCT, <span><span>NCT06113458</span><svg><path></path></svg></span>. Registered 23 October 2023, <span><span>https://clinicaltrials.gov/study/NCT06113458</span><svg><path></path></svg></span></div></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\"152 \",\"pages\":\"Article 107879\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-03-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1551714425000734\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714425000734","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

摘要

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

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

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

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

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.