JAMA:黑人和西班牙裔中风患者的家庭血压远程监护和护理病例管理:一项随机临床试验

2024-06-08 来源:JAMA

本文由小咖机器人翻译整理

期刊来源:JAMA

原文链接:https://doi.org/10.1001/jama.2024.6609

摘要内容如下:

重要性

在美国,黑人和西班牙裔患者中风复发和高血压失控的发生率很高。家庭血压远程监护(HBPTM)和电话护士个案管理(NCM)在低收入黑人和西班牙裔中风患者中的有效性尚不清楚。

目的

确定在高血压未控制的黑人和西班牙裔卒中存活者中,NCM联合HBPTM是否比单独使用HBPTM在12个月时更能降低收缩压(SBP),在24个月时更能降低卒中复发率。

设计、设置和参与者

在纽约市8个卒中中心和门诊诊所进行的基于实践的多中心随机临床试验。黑人和西班牙裔研究参与者在2014年4月18日至2017年12月19日期间入组,并于2019年12月31日进行了最后一次随访。

干预措施

参与者被随机分配接受单独的HBPTM(每周12次家庭血压测量,持续12个月,并将结果传送给临床医生;n=226)或NCM+HBPTM(12个月内20次咨询电话;N=224)。

主要成果和措施

主要转归是12个月时的收缩压变化和24个月时的卒中复发率。最终统计分析于2024年3月14日完成。

结果

在纳入并随机分组的450名参与者中(平均[SD]年龄,61.7[11.0]岁;51%为黑人[n=231];44%为女性[n=200];31%的患者有≥3种共病情况[n=137];72%的家庭收入<$25000/y[n=234/324]),358(80%)完成了试验。在12个月时,NCM+HBPTM组的收缩压下降幅度显著大于单纯HBPTM组(分别为-15.1 mm Hg[95%CI,-17.2~-13.0]vs-5.8 mm Hg[95%CI,-7.9~-3.7];P<.001)。在12个月时,经初级保健医生聚类调整后,收缩压降低的组间差异为-8.1 mm Hg(95%CI,-11.2至-5.0;12个月时P<.001)。24个月时,两组的卒中复发率相似(NCM+HBPTM组为4.0%,HBPTM单用组为4.0%,P>0.99)。

结论和相关性

在患有未控制的高血压的主要低收入黑人和西班牙裔卒中幸存者中,在HBPTM中加入NCM比单独使用HBPTM更能降低收缩压。需要更多的研究来了解NCM增强的远程医疗计划在具有显著合并症的低收入黑人和西班牙裔中风幸存者中的长期临床结果、成本效益和可推广性。

试用注册

Clinical Trials.gov标识符:NCT02011685。

英文原文如下:

Abstracts

Importance  Black and Hispanic patients have high rates of recurrent stroke and uncontrolled hypertension in the US. The effectiveness of home blood pressure telemonitoring (HBPTM) and telephonic nurse case management (NCM) among low-income Black and Hispanic patients with stroke is unknown.

Objective  To determine whether NCM plus HBPTM results in greater systolic blood pressure (SBP) reduction at 12 months and lower rate of stroke recurrence at 24 months than HBPTM alone among Black and Hispanic stroke survivors with uncontrolled hypertension.

Design, Setting, and Participants  Practice-based, multicenter, randomized clinical trial in 8 stroke centers and ambulatory practices in New York City. Black and Hispanic study participants were enrolled between April 18, 2014, and December 19, 2017, with a final follow-up visit on December 31, 2019.

Interventions  Participants were randomly assigned to receive either HBPTM alone (12 home BP measurements/week for 12 months, with results transmitted to a clinician; n = 226) or NCM plus HBPTM (20 counseling calls over 12 months; n = 224).

Main Outcomes and Measures  Primary outcomes were change in SBP at 12 months and rate of recurrent stroke at 24 months. Final statistical analyses were completed March 14, 2024.

Results  Among 450 participants who were enrolled and randomized (mean [SD] age, 61.7 [11.0] years; 51% were Black [n = 231]; 44% were women [n = 200]; 31% had ≥3 comorbid conditions [n = 137]; 72% had household income <$25 000/y [n = 234/324]), 358 (80%) completed the trial. Those in the NCM plus HBPTM group had a significantly greater SBP reduction than those in the HBPTM alone group at 12 months (-15.1 mm Hg [95% CI, -17.2 to -13.0] vs -5.8 mm Hg [95% CI, -7.9 to -3.7], respectively; P < .001). The between-group difference in SBP reduction at 12 months, adjusted for primary care physician clustering, was -8.1 mm Hg (95% CI, -11.2 to -5.0; P < .001) at 12 months. The rate of recurrent stroke was similar between both groups at 24 months (4.0% in the NCM plus HBPTM group vs 4.0% in the HBPTM alone group, P > .99).

Conclusions and Relevance  Among predominantly low-income Black and Hispanic stroke survivors with uncontrolled hypertension, addition of NCM to HBPTM led to greater SBP reduction than HBPTM alone. Additional studies are needed to understand the long-term clinical outcomes, cost-effectiveness, and generalizability of NCM-enhanced telehealth programs among low-income Black and Hispanic stroke survivors with significant comorbidity.

Trial Registration  Clinical Trials.gov Identifier: NCT02011685.

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