Spruill Tanya M, Williams Olajide, Teresi Jeanne A, Lehrer Susan, Pezzin Liliana, Waddy Salina P, Lazar Ronald M, Williams Stephen K, Jean-Louis Girardin, Ravenell Joseph, Penesetti Sunil, Favate Albert, Flores Judith, Henry Katherine A, Kleiman Anne, Levine Steven R, Sinert Richard, Smith Teresa Y, Stern Michelle, Valsamis Helen, Ogedegbe Gbenga
New York University School of Medicine, 227 East 30th Street, Room 640, 10016, New York, NY, USA.
Department of Neurology, Columbia University Medical School, New York, NY, USA.
Trials. 2015 Mar 15;16:97. doi: 10.1186/s13063-015-0605-5.
Black and Hispanic stroke survivors experience higher rates of recurrent stroke than whites. This disparity is partly explained by disproportionately higher rates of uncontrolled hypertension in these populations. Home blood pressure telemonitoring (HBPTM) and nurse case management (NCM) have proven efficacy in addressing the multilevel barriers to blood pressure (BP) control and reducing BP. However, the effectiveness of these interventions has not been evaluated in stroke patients. This study is designed to evaluate the comparative effectiveness, cost-effectiveness and sustainability of these two telehealth interventions in reducing BP and recurrent stroke among high-risk Black and Hispanic stroke survivors with uncontrolled hypertension.
METHODS/DESIGN: A total of 450 Black and Hispanic patients with recent nondisabling stroke and uncontrolled hypertension are randomly assigned to one of two 12-month interventions: 1) HBPTM with wireless feedback to primary care providers or 2) HBPTM plus individualized, culturally-tailored, telephone-based NCM. Patients are recruited from stroke centers and primary care practices within the Health and Hospital Corporations (HHC) Network in New York City. Study visits occur at baseline, 6, 12 and 24 months. The primary outcomes are within-patient change in systolic BP at 12 months, and the rate of stroke recurrence at 24 months. The secondary outcome is the comparative cost-effectiveness of the interventions at 12 and 24 months; and exploratory outcomes include changes in stroke risk factors, health behaviors and treatment intensification. Recruitment for the stroke telemonitoring hypertension trial is currently ongoing.
The combination of two established and effective interventions along with the utilization of health information technology supports the sustainability of the HBPTM + NCM intervention and feasibility of its widespread implementation. Results of this trial will provide strong empirical evidence to inform clinical guidelines for management of stroke in minority stroke survivors with uncontrolled hypertension. If effective among Black and Hispanic stroke survivors, these interventions have the potential to substantially mitigate racial and ethnic disparities in stroke recurrence.
ClinicalTrials.gov NCT02011685 . Registered 10 December 2013.
与白人相比，黑人及西班牙裔中风幸存者复发性中风的发生率更高。这些人群中高血压控制不佳的比例过高，这在一定程度上解释了这种差异。家庭血压远程监测（HBPTM）和护士病例管理（NCM）已被证明在解决血压（BP）控制的多层次障碍和降低血压方面具有疗效。然而，这些干预措施在中风患者中的有效性尚未得到评估。本研究旨在评估这两种远程医疗干预措施在降低血压和复发性中风方面对患有未控制高血压的高危黑人和西班牙裔中风幸存者的相对有效性、成本效益和可持续性。
方法/设计：总共450名近期发生非致残性中风且患有未控制高血压的黑人和西班牙裔患者被随机分配到两种为期12个月的干预措施之一：1）向初级保健提供者提供无线反馈的HBPTM，或2）HBPTM加个性化、文化定制的电话NCM。患者从纽约市卫生和医院公司（HHC）网络内的中风中心和初级保健机构招募。研究访视在基线、6个月、12个月和24个月进行。主要结局是12个月时患者收缩压的变化，以及24个月时中风复发率。次要结局是干预措施在12个月和24个月时的相对成本效益；探索性结局包括中风危险因素、健康行为和治疗强化的变化。中风远程监测高血压试验目前正在招募患者。
两种既定且有效的干预措施与健康信息技术的结合支持了HBPTM + NCM干预措施的可持续性及其广泛实施的可行性。该试验的结果将提供有力的实证证据，为管理患有未控制高血压的少数族裔中风幸存者的临床指南提供参考。如果这些干预措施在黑人和西班牙裔中风幸存者中有效，它们有可能大幅减轻中风复发方面的种族和族裔差异。
ClinicalTrials.gov NCT02011685。2013年12月10日注册。
