Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 19, 2019
Date Accepted: Feb 26, 2020
The Box 2.0, using smart technology for early diagnosis of complications after cardiac surgery: a study protocol.
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 outcome. Remote monitoring with the use of a smartphone (mHealth) might improve early detection of complications after cardiac surgery.
Objective:
The primary aim of this study is to compare 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 quality of life, patient satisfaction and cost-effectiveness.
Methods:
The Box 2.0 is a study with a prospective intervention arm and a historical control group as a comparison. Patients who undergo cardiac surgery at the Leiden University Medical Center are eligible for enrollment; 365 historical patients are used as a control group and 365 other participants will be asked to receive either The Box intervention, consisting of 7 home measurement devices combined with a video consultation two 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 consists of a blood pressure monitor, thermometer, weight scale, step count watch, single-lead electrocardiogram (ECG) device, an 12-lead ECG device and a pulse oximeter.
Results:
The primary outcome of this study is the detection rate of AF in both groups. Quality of life is measured with the EQ-5D-5L questionnaire. Cost-effectiveness is calculated from a society’s perspective using prices from Dutch costing guidelines and quality of life data from the study. In the historical cohort, 93,9% have completed 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 is presented. First results are expected in September 2020. Clinical Trial: NCT03690492 at clinicaltrials.gov NL65959.058.18 at toetsingonline.nl
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