Biersteker Tom E, Boogers Mark J, de Lind van Wijngaarden Robert Af, Groenwold Rolf Hh, Trines Serge A, van Alem Anouk P, Kirchhof Charles Jhj, van Hof Nicolette, Klautz Robert Jm, Schalij Martin J, Treskes Roderick W
Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.
Department of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, Netherlands.
JMIR Res Protoc. 2020 Apr 21;9(4):e16326. doi: 10.2196/16326.
Atrial fibrillation (AF), sternal wound infection, and cardiac decompensation are complications that can occur after cardiac surgery. Early detection of these complications is clinically relevant, as early treatment is associated with better clinical outcomes. Remote monitoring with the use of a smartphone (mobile health [mHealth]) might improve the early detection of complications after cardiac surgery.
The primary aim of this study is to compare the detection rate of AF diagnosed with an mHealth solution to the detection rate of AF diagnosed with standard care. Secondary objectives include detection of sternal wound infection and cardiac decompensation, as well as assessment of quality of life, patient satisfaction, and cost-effectiveness.
The Box 2.0 is a study with a prospective intervention group and a historical control group for comparison. Patients undergoing cardiac surgery at Leiden University Medical Center are eligible for enrollment. In this study, 365 historical patients will be used as controls and 365 other participants will be asked to receive either The Box 2.0 intervention consisting of seven home measurement devices along with a video consultation 2 weeks after discharge or standard cardiac care for 3 months. Patient information will be analyzed according to the intention-to-treat principle. The Box 2.0 devices include a blood pressure monitor, thermometer, weight scale, step count watch, single-lead electrocardiogram (ECG) device, 12-lead ECG device, and pulse oximeter.
The study started in November 2018. The primary outcome of this study is the detection rate of AF in both groups. Quality of life is measured with the five-level EuroQol five-dimension (EQ-5D-5L) questionnaire. Cost-effectiveness is calculated from a society perspective using prices from Dutch costing guidelines and quality of life data from the study. In the historical cohort, 93.9% (336/358) completed the EQ-5D-5L and patient satisfaction questionnaires 3 months after cardiac surgery.
The rationale and design of a study to investigate mHealth devices in postoperative cardiac surgery patients are presented. The first results are expected in September 2020.
ClinicalTrials.gov NCT03690492; http://clinicaltrials.gov/show/NCT03690492.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16326.
心房颤动（AF）、胸骨伤口感染和心脏代偿失调是心脏手术后可能出现的并发症。这些并发症的早期检测具有临床相关性，因为早期治疗与更好的临床结果相关。使用智能手机进行远程监测（移动健康[mHealth]）可能会改善心脏手术后并发症的早期检测。
本研究的主要目的是比较通过移动健康解决方案诊断出的房颤检测率与通过标准护理诊断出的房颤检测率。次要目标包括检测胸骨伤口感染和心脏代偿失调，以及评估生活质量、患者满意度和成本效益。
Box 2.0是一项研究，有一个前瞻性干预组和一个历史对照组用于比较。在莱顿大学医学中心接受心脏手术的患者有资格入选。在本研究中，365名历史患者将作为对照组，另外365名参与者将被要求接受Box 2.0干预，该干预包括七个家庭测量设备以及出院后2周的视频咨询，或者接受3个月的标准心脏护理。患者信息将根据意向性分析原则进行分析。Box 2.0设备包括血压监测仪、温度计、体重秤、计步手表、单导联心电图（ECG）设备、12导联ECG设备和脉搏血氧仪。
该研究于2018年11月开始。本研究的主要结果是两组中房颤的检测率。生活质量使用五级欧洲五维健康量表（EQ-5D-5L）问卷进行测量。成本效益从社会角度使用荷兰成本核算指南中的价格和研究中的生活质量数据进行计算。在历史队列中，93.9%（336/358）的患者在心脏手术后3个月完成了EQ-5D-5L和患者满意度问卷。
本文介绍了一项调查心脏手术后患者移动健康设备的研究的基本原理和设计。预计2020年9月得出初步结果。
ClinicalTrials.gov NCT03690492；http://clinicaltrials.gov/show/NCT03690492。
国际注册报告识别码（IRRID）：DERR1-10.2196/16326。
