Department of Neurology and Cerebrovascular Center, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Nowon Eulji Medical Center, Department of Neurology, Eulji University, Seoul, Republic of Korea.
PLoS One. 2020 Mar 11;15(3):e0229483. doi: 10.1371/journal.pone.0229483. eCollection 2020.
Measuring blood pressure (BP) at home and remote monitoring can improve the patient's adherence to BP control and vascular outcomes. This study evaluated the feasibility of a trial regarding the effects of an intensive mobile BP management strategy versus usual care in acute ischemic stroke patients. A feasibility-testing, randomized, open-labeled controlled trial was conducted. Remote BP measurement, data transmission, storage, and centralized monitoring system were organized through a Bluetooth-equipped sphygmomanometer paired to the participants' smartphones. Participants were randomized equally into intensive management (behavioral intensification to measure BP at home by texting, direct telephone call, or breakthrough visit) and control (usual care) groups. The primary feasibility outcomes were: 1) recruitment time for the pre-specified number of participants, 2) retention of participants, 3) frequency of breakthrough visit calls, 4) response to breakthrough visit call, and 5) proportions satisfying BP measurement criteria. Sixty participants were randomly assigned to the intensive management (n = 31) and control (n = 29) groups, of which 57 participants were included in the primary analysis with comparable baseline characteristics. Recruitment time from the first to the last participant was 350 days, and 95% of randomized participants completed the final visit (intensive, 94%; control, 98%). Eight breakthrough visit calls were made to 7 participants (23%), with complete and immediate responses within 3 ± 4 days. The median of half-day blocks fulfilling the BP measurement criteria per patient were 91% in the intensive group and 83% in the control group (difference, 12.2; 95% confidence interval, 2.2-22.2). No adverse events related to the trial procedures were reported. The intensive monitoring, including remote BP measurement, data transfer, and centralized monitoring system, engaged with behavioral intensification was feasible if the patients complied with the intervention. However, the device utilized would need further improvement prior to a large trial.
在家测量血压（BP）和远程监测可以提高患者对血压控制和血管结果的依从性。本研究评估了一项关于强化移动 BP 管理策略与常规护理对急性缺血性脑卒中患者影响的试验的可行性。进行了一项可行性测试、随机、开放标签对照试验。通过配备蓝牙的血压计与参与者的智能手机配对，组织远程血压测量、数据传输、存储和集中监测系统。参与者被平均随机分为强化管理（通过短信、直接电话或突破访问来加强家庭血压测量）和对照组。主要可行性结果为：1）按预定数量招募参与者的时间，2）参与者保留率，3）突破访问电话的频率，4）对突破访问电话的反应，以及 5）满足 BP 测量标准的比例。60 名参与者被随机分配到强化管理组（n = 31）和对照组（n = 29），其中 57 名参与者纳入主要分析，基线特征具有可比性。从第一名参与者到最后一名参与者的招募时间为 350 天，95%的随机参与者完成了最后一次就诊（强化组 94%；对照组 98%）。对 7 名参与者（23%）进行了 8 次突破访问，在 3 ± 4 天内完成并立即回复。强化组每位患者满足 BP 测量标准的半天块中位数为 91%，对照组为 83%（差异，12.2；95%置信区间，2.2-22.2）。没有报告与试验程序相关的不良事件。如果患者依从性高，包括远程血压测量、数据传输和集中监测系统在内的强化监测是可行的。然而，在进行大规模试验之前，需要对该设备进行进一步改进。
