Use of Smart Technology for the Early Diagnosis of Complications After Cardiac Surgery: The Box 2.0 Study Protocol

Tom E Biersteker, Mark J Boogers, Robert Af de Lind van Wijngaarden, Rolf Hh Groenwold, Serge A Trines, Anouk P van Alem, Charles Jhj Kirchhof, Nicolette van Hof, Robert Jm Klautz, Martin J Schalij, Roderick W Treskes, Tom E Biersteker, Mark J Boogers, Robert Af de Lind van Wijngaarden, Rolf Hh Groenwold, Serge A Trines, Anouk P van Alem, Charles Jhj Kirchhof, Nicolette van Hof, Robert Jm Klautz, Martin J Schalij, Roderick W Treskes

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT03690492; https://ichgcp.net/clinical-trials-registry/NCT03690492.

International registered report identifier (irrid): DERR1-10.2196/16326.

Keywords: ambulatory electrocardiography; atrial fibrillation; cardiac surgery; mHealth; postoperative care.

Conflict of interest statement

Conflicts of Interest: None declared.

©Tom E Biersteker, Mark J Boogers, Robert AF de Lind van Wijngaarden, Rolf HH Groenwold, Serge A Trines, Anouk P van Alem, Charles JHJ Kirchhof, Nicolette van Hof, Robert JM Klautz, Martin J Schalij, Roderick W Treskes. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.04.2020.

Figures

Figure 1
Figure 1
The devices of The Box 2.0.
Figure 2
Figure 2
Flowchart for the outpatient clinic follow-up. Left: standard outpatient care without the mHealth intervention. Right: outpatient care with the mHealth intervention. Blue text boxes show the standard topics at 14-day and 3-month consultations. Green text boxes and text highlight the mHealth intervention. ECG: electrocardiogram; NP: nurse practitioner.
Figure 3
Figure 3
An electrocardiogram obtained with the CardioSecur device.
Figure 4
Figure 4
A lead-I electrocardiogram obtained with the AliveCor Kardia device.

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