Okpala Munachi, Izeogu Chigozirim, Wang Mengxi, Green Charles, Cooksey Gabretta, Nguyen Thuy, Cohen Sarah, Bryant Latonya, Hernandez Daphne C, Bernstam Elmer V, Gonzales Michael, Conyers Rhonda, Chiadika Olasimbo, Varacalli Kristin, Savitz Sean I, Yamal Jose-Miguel, Sharrief Anjail Z
Department of Neurology, McGovern Medical School at UTHealth Houston | UTHSC:, The University of Texas Health Science Center at Houston , Houston, TX, USA.
Department of Biostatistics and Data Science, Coordinating Center for Clinical Trials, UTHealth Houston School of Public Health, The University of Texas Health Science Center at Houston, Houston, TX, USA.
Trials. 2025 Aug 12;26(1):288. doi: 10.1186/s13063-025-09003-5.
Racial and ethnic disparities in post-stroke blood pressure (BP) control persist, and effective interventions to address post-stroke care inequities are needed. We designed a randomized comparative effectiveness trial to evaluate the Video-based Intervention to Reduce Treatment and Outcome Disparities in Adults Living with Stroke or Transient Ischemic Attack (VIRTUAL) model of care for post-stroke BP reduction.
The study will enroll 534 stroke survivors in a randomized trial to receive either the VIRTUAL intervention or enhanced standard care. Individuals with ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA) are enrolled before hospital discharge and randomized (1:1) to VIRTUAL or ESC for their post-stroke care. The VIRTUAL care model is a social risk-informed telehealth intervention that incorporates remote BP monitoring and multidisciplinary clinical care from a clinical provider, pharmacist, and social worker. Telehealth (TH) based clinical visits occur 7, 30, 90, and 150 days after hospital discharge with the multidisciplinary care team. Pharmacists monitor and manage BP between telehealth visits for 6 months after enrollment. Patients randomized to ESC receive standard post-stroke follow-up, a BP monitor (without remote capabilities), and pharmacist-engaged care (monthly calls and communication to primary care). The primary outcome is BP control (< 125/75 mmHg) assessed with 24-h ambulatory BP monitoring (ABPM) 6 months after hospital discharge. The secondary outcomes are 24-h ABPM-assessed BP control (< 125/75 mmHg) at 12 months, 6- and 12-month mean systolic and diastolic ambulatory BP, 12-month composite recurrent vascular events, insurance coverage at 3 and 6 months, hospital readmission rates, and acute healthcare utilization (emergency room and urgent care visits) at 3, 6, and 12 months after hospital discharge.
The VIRTUAL care model represents a novel approach to addressing post-stroke BP control disparities. The intervention aims to improve BP control and reduce disparities in a diverse patient population by integrating telehealth with a multidisciplinary team approach and social risk-informed care. Findings from this study will inform evidence-based strategies for enhancing post-stroke care delivery, particularly in underserved populations, and may contribute to reducing healthcare disparities among racial and ethnic groups.
ClinicalTrials.gov. NCT05264298. Registered on March 3, 2022. URL of trial registry record: https://clinicaltrials.gov/study/NCT05264298?cond=stroke&term=virtual%20&rank=2 .
Protocol version 1.5, approved May 15, 2024. Recruitment started on March 29, 2022, and was completed on April 28, 2025.
中风后血压控制方面的种族和民族差异依然存在，因此需要有效的干预措施来解决中风后护理不平等的问题。我们设计了一项随机对照有效性试验，以评估基于视频的干预措施，该措施旨在减少中风或短暂性脑缺血发作成年患者治疗和结局差异（VIRTUAL），用于降低中风后的血压。
该研究将招募534名中风幸存者参与一项随机试验，他们将接受VIRTUAL干预或强化标准护理。缺血性中风、出血性中风或短暂性脑缺血发作（TIA）患者在出院前入组，并随机（1:1）分配接受VIRTUAL或强化标准护理以进行中风后护理。VIRTUAL护理模式是一种基于社会风险的远程医疗干预措施，它结合了远程血压监测以及临床医生、药剂师和社会工作者提供的多学科临床护理。出院后7天、30天、90天和150天，多学科护理团队通过远程医疗（TH）进行临床访视。药剂师在入组后6个月的远程医疗访视间隔期间监测和管理血压。随机分配到强化标准护理组的患者接受标准的中风后随访、一个血压监测仪（无远程功能）以及药剂师参与的护理（每月打电话并与初级保健机构沟通）。主要结局是出院6个月后通过24小时动态血压监测（ABPM）评估的血压控制情况（<125/75 mmHg）。次要结局包括出院12个月时通过24小时ABPM评估的血压控制情况（<125/75 mmHg）、6个月和12个月时的平均收缩压和舒张压动态血压、12个月时的复合复发性血管事件、3个月和6个月时的保险覆盖情况、住院再入院率以及出院后3个月、6个月和12个月时的急性医疗利用情况（急诊室和紧急护理就诊）。
VIRTUAL护理模式是解决中风后血压控制差异的一种新方法。该干预措施旨在通过将远程医疗与多学科团队方法以及基于社会风险的护理相结合，改善血压控制并减少不同患者群体之间的差异。本研究的结果将为加强中风后护理提供基于证据的策略，特别是在服务不足的人群中，并可能有助于减少种族和民族群体之间的医疗差异。
ClinicalTrials.gov。NCT05264298。于2022年3月3日注册。试验注册记录的网址：https://clinicaltrials.gov/study/NCT05264298?cond=stroke&term=virtual%20&rank=2 。
方案版本1.5，于2024年5月15日批准。招募工作于2022年3月29日开始，并于2025年4月28日完成。
