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Abstract：
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.
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.
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.
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).
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.
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).
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.
Clinical Trials.gov Identifier: NCT02011685.
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.
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.
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).
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.
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).
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.
Clinical Trials.gov Identifier: NCT02011685.
摘要：
在美国，黑人和西班牙裔患者的复发性中风和不受控制的高血压发生率很高。在低收入的黑人和西班牙裔中风患者中，家庭血压远程监测（HBPTM）和电话护士病例管理（NCM）的有效性尚不清楚。
■为了确定NCM加HBPTM是否导致12个月时收缩压（SBP）降低和24个月时卒中复发率低于单独的HBPTM，黑人和西班牙裔卒中幸存者未控制的高血压。
■以实践为基础，多中心，在纽约市的8个卒中中心和门诊诊所进行的随机临床试验。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日之间注册，最后一次随访于2019年12月31日。
■参与者被随机分配单独接受HBPTM（12个家庭血压测量/周，持续12个月，将结果传送给临床医生；n=226）或NCM加HBPTM（12个月内20次咨询电话；n=224）。
■主要结果是12个月时SBP的变化和24个月时卒中的复发率。最终统计分析于2024年3月14日完成。
■在450名登记和随机分组的参与者中(平均[SD]年龄，61.7[11.0]年；51%为黑人[n=231]；44%为女性[n=200]；31%有≥3种合并症[n=137]；72%的家庭收入<$25000/y[n=234/324]），358(80%)完成试验。在12个月时，NCM加HBPTM组的SBP降低幅度明显高于单独HBPTM组（-15.1mmHg[95％CI，-17.2至-13.0]vs-5.8mmHg[95％CI，-7.9至-3.7]，分别；P<.001）。12个月时SBP降低的组间差异，针对初级保健医生集群进行了调整，12个月时为-8.1mmHg（95%CI，-11.2至-5.0；P<.001）。在24个月时，两组之间的复发性卒中发生率相似（NCM加HBPTM组的4.0%与单独HBPTM组的4.0%，P>.99）。
■在高血压不受控制的低收入黑人和西班牙裔中风幸存者中，与单独的HBPTM相比，在HBPTM中添加NCM导致SBP降低更大。需要更多的研究来了解长期临床结果，成本效益，在低收入的黑人和西班牙裔中风幸存者中，NCM增强的远程医疗计划具有普遍性，患有严重合并症。
■临床试验.gov标识符：NCT02011685。
■为了确定NCM加HBPTM是否导致12个月时收缩压（SBP）降低和24个月时卒中复发率低于单独的HBPTM，黑人和西班牙裔卒中幸存者未控制的高血压。
■以实践为基础，多中心，在纽约市的8个卒中中心和门诊诊所进行的随机临床试验。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日之间注册，最后一次随访于2019年12月31日。
■参与者被随机分配单独接受HBPTM（12个家庭血压测量/周，持续12个月，将结果传送给临床医生；n=226）或NCM加HBPTM（12个月内20次咨询电话；n=224）。
■主要结果是12个月时SBP的变化和24个月时卒中的复发率。最终统计分析于2024年3月14日完成。
■在450名登记和随机分组的参与者中(平均[SD]年龄，61.7[11.0]年；51%为黑人[n=231]；44%为女性[n=200]；31%有≥3种合并症[n=137]；72%的家庭收入<$25000/y[n=234/324]），358(80%)完成试验。在12个月时，NCM加HBPTM组的SBP降低幅度明显高于单独HBPTM组（-15.1mmHg[95％CI，-17.2至-13.0]vs-5.8mmHg[95％CI，-7.9至-3.7]，分别；P<.001）。12个月时SBP降低的组间差异，针对初级保健医生集群进行了调整，12个月时为-8.1mmHg（95%CI，-11.2至-5.0；P<.001）。在24个月时，两组之间的复发性卒中发生率相似（NCM加HBPTM组的4.0%与单独HBPTM组的4.0%，P>.99）。
■在高血压不受控制的低收入黑人和西班牙裔中风幸存者中，与单独的HBPTM相比，在HBPTM中添加NCM导致SBP降低更大。需要更多的研究来了解长期临床结果，成本效益，在低收入的黑人和西班牙裔中风幸存者中，NCM增强的远程医疗计划具有普遍性，患有严重合并症。
■临床试验.gov标识符：NCT02011685。
