Abstract
BackgroundAtrial 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.ObjectiveThe 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.MethodsThe 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.ResultsThe 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.ConclusionsThe 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.Trial RegistrationClinicalTrials.gov NCT03690492; http://clinicaltrials.gov/show/NCT03690492International Registered Report Identifier (IRRID)DERR1-10.2196/16326
Highlights
Over the past decades, major advances have been made to improve the safety of cardiac surgery in order to decrease the risk of adverse events [1]
Sternal wound infection occurs in 3% to 5% of cases, with mediastinitis occurring in 1% to 2% of all cases [6,7,8]
The aim of this study is to investigate the clinical effectiveness of a smart technology intervention in patients after cardiac surgery
Summary
Major advances have been made to improve the safety of cardiac surgery in order to decrease the risk of adverse events [1]. The most frequently occurring postoperative complications are cardiac decompensation, late tamponade, and rhythm disturbances, such as atrial fibrillation (AF). In approximately 25% of all patients, one or more of these complications occur, and they are mostly noted in the ward at day 2 or 3 after surgery [2,3,4]. Late-onset sternal wound infection is defined as sternal wound infection occurring 14 days or later after the initial surgery, and it is relatively as frequent as early-onset sternal wound infection [9]. Atrial fibrillation (AF), sternal wound infection, and cardiac decompensation are complications that can occur after cardiac surgery. 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
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