ArticleJMIR research protocols2020
Use of Smart Technology for the Early Diagnosis of Complications After Cardiac Surgery: The Box 2.0 Study Protocol.
Article in JMIR research protocols, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03690492 (The Box 2.0), which is not on this map. Cited by 10 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Box 2.0: Using Smart Technology for Early Diagnosis of Complications After Cardiovascular Surgery
Who cites it
10 citing papers in PubMed, 14 citations in OpenAlex.
- mHealth Technologies for the Care of Children With Congenital Heart Disease: Scoping Review.JMIR mHealth and uHealth · 2026Article
- Home-Based Intervention Tool for Cardiac Telerehabilitation: Protocol for a Controlled Trial.JMIR research protocols · 2025Article
- Mobile health for cardiovascular risk management after cardiac surgery: results of a sub-analysis of The Box 2.0 study.European heart journal. Digital health · 2023Article
- Relationship between Complete Revascularization and Survival after Post-Infarction Ventricular Septal Rupture.ARYA atherosclerosis · 2023Article
- Mobile health vs. standard care after cardiac surgery: results of The Box 2.0 study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023Observational
- Use of a mobile health application by adult non-congenital cardiac surgery patients: A feasibility study.PLOS digital health · 2022Article
- Telemedicine in Cardiology: Modern Technologies to Improve Cardiovascular Patients' Outcomes-A Narrative Review.Medicina (Kaunas, Lithuania) · 2022Review
- Real-World Experience of mHealth Implementation in Clinical Practice (the Box): Design and Usability Study.JMIR cardio · 2021Article
- Adoption of Telemedicine: A Debrief for the Orthopedic Practitioner.HSS journal : the musculoskeletal journal of Hospital for Special Surgery · 2021Article
- Continuum of Care: Positioning of the Virtual Hospital.Frontiers in cardiovascular medicine · 2021Article
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Authors and funding
11 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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/NCT03690492. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16326.
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