Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial.
Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial.
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DOI：
10.2196/jmir.1252
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发表时间：
2009-08-17
影响因子：
7.4
通讯作者：
MOBITEL Investigators
中科院分区：
文献类型：
--
作者：
Scherr D;Kastner P;Kollmann A;Hallas A;Auer J;Krappinger H;Schuchlenz H;Stark G;Grander W;Jakl G;Schreier G;Fruhwald FM;MOBITEL Investigators
慢性心力衰竭(CHF)患者的远程监护是一个新兴的概念，用于检测即将到来的急性失代偿的早期预警迹象，以防止住院治疗。心力衰竭患者移动远程监护研究(Mobitel)的目标是评估使用互联网和手机技术的家庭远程监护对急性失代偿后心力衰竭患者结局的影响。患者被随机分配到药物治疗(对照组)或药物治疗加远程医疗监测(TELE组)6个月。被随机分为远程组的患者配备了基于手机的患者终端，用于数据采集和数据传输到监测中心。研究医生可以通过安全的门户网站连续访问数据。如果传输的值超出了可单独调整的范围，研究医生会收到一封电子邮件警报。主要终点是因心力衰竭恶化或因心血管原因死亡而住院。120例患者(男性85例，女性35例)随机分组后停止研究；中位年龄为66岁(IQR62-72)。对照组54例(男39例，女15例)，中位年龄67岁(IQR61-72)；TELE组54例(男40例，女14例)，中位年龄65岁(IQR62-72)。在基线特征方面，两组之间没有显著差异。12名远程组患者无法开始数据传输，原因是这些患者无法正确操作手机(“从未入门”)。有4名患者因个人原因未能完成研究。研究结束时的意向治疗分析表明，18名对照组患者(33%)达到了主要终点(1例死亡，17例住院)，而远程组有11例患者(17%，0例死亡，11例住院；相对风险降低50%，95%可信区间3-74%，P=0.06)。按方案分析显示，15%的远程组患者(0例死亡，8例住院)达到了主要终点(相对风险降低54%，95%可信区间7-79%，P=0.04)。仅Tele组患者的NYHA分级提高了一级(P<；.001)。在研究期间因心力衰竭恶化而住院的TELE组患者的住院时间(中位数6.5天，IQR 5.5-8.3)明显短于对照组患者(中位数10.0天，IQR 7.0-13.0；P=0.04)。初学者的事件发生率不高于对照组患者。使用移动电话作为患者终端的远程监护有可能减少心力衰竭住院的频率和持续时间。为老年患者提供足够的用户界面用于日常数据采集仍然是这一概念的一个具有挑战性的组成部分。
Telemonitoring of patients with chronic heart failure (CHF) is an emerging concept to detect early warning signs of impending acute decompensation in order to prevent hospitalization. The goal of the MOBIle TELemonitoring in Heart Failure Patients Study (MOBITEL) was to evaluate the impact of home-based telemonitoring using Internet and mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation. Patients were randomly allocated to pharmacological treatment (control group) or to pharmacological treatment with telemedical surveillance for 6 months (tele group). Patients randomized into the tele group were equipped with mobile phone–based patient terminals for data acquisition and data transmission to the monitoring center. Study physicians had continuous access to the data via a secure Web portal. If transmitted values went outside individually adjustable borders, study physicians were sent an email alert. Primary endpoint was hospitalization for worsening CHF or death from cardiovascular cause. The study was stopped after randomization of 120 patients (85 male, 35 female); median age was 66 years (IQR 62-72). The control group comprised 54 patients (39 male, 15 female) with a median age of 67 years (IQR 61-72), and the tele group included 54 patients (40 male, 14 female) with a median age of 65 years (IQR 62-72). There was no significant difference between groups with regard to baseline characteristics. Twelve tele group patients were unable to begin data transmission due to the inability of these patients to properly operate the mobile phone (“never beginners”). Four patients did not finish the study due to personal reasons. Intention-to-treat analysis at study end indicated that 18 control group patients (33%) reached the primary endpoint (1 death, 17 hospitalizations), compared with 11 tele group patients (17%, 0 deaths, 11 hospitalizations; relative risk reduction 50%, 95% CI 3-74%, P = .06). Per-protocol analysis revealed that 15% of tele group patients (0 deaths, 8 hospitalizations) reached the primary endpoint (relative risk reduction 54%, 95% CI 7-79%, P= .04). NYHA class improved by one class in tele group patients only (P< .001). Tele group patients who were hospitalized for worsening heart failure during the study had a significantly shorter length of stay (median 6.5 days, IQR 5.5-8.3) compared with control group patients (median 10.0 days, IQR 7.0-13.0; P= .04). The event rate of never beginners was not higher than the event rate of control group patients. Telemonitoring using mobile phones as patient terminals has the potential to reduce frequency and duration of heart failure hospitalizations. Providing elderly patients with an adequate user interface for daily data acquisition remains a challenging component of such a concept.
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