دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: Use of Smart Technology for the Early Diagnosis of Complications After Cardiac Surgery: The Box 2.0 Study Protocol.
المؤلفون: Biersteker TE; Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands., Boogers MJ; Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands., de Lind van Wijngaarden RA; Department of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, Netherlands., Groenwold RH; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, Netherlands., Trines SA; Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands., van Alem AP; Department of Cardiology, Haaglanden Medisch Centrum, Den Haag, Netherlands., Kirchhof CJ; Department of Cardiology, Alrijne Ziekenhuis, Leiderdorp, Netherlands., van Hof N; Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands., Klautz RJ; Department of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, Netherlands., Schalij MJ; Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands., Treskes RW; Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.
المصدر: JMIR research protocols [JMIR Res Protoc] 2020 Apr 21; Vol. 9 (4), pp. e16326. Date of Electronic Publication: 2020 Apr 21.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: JMIR Publications Country of Publication: Canada NLM ID: 101599504 Publication Model: Electronic Cited Medium: Print ISSN: 1929-0748 (Print) Linking ISSN: 19290748 NLM ISO Abbreviation: JMIR Res Protoc Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: Toronto : JMIR Publications
مستخلص: 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; http://clinicaltrials.gov/show/NCT03690492.
International Registered Report Identifier (irrid): DERR1-10.2196/16326.
(©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.)
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فهرسة مساهمة: Keywords: ambulatory electrocardiography; atrial fibrillation; cardiac surgery; mHealth; postoperative care
سلسلة جزيئية: ClinicalTrials.gov NCT03690492
تواريخ الأحداث: Date Created: 20200422 Latest Revision: 20200928
رمز التحديث: 20240829
مُعرف محوري في PubMed: PMC7201318
DOI: 10.2196/16326
PMID: 32314974
قاعدة البيانات: MEDLINE
الوصف
تدمد:1929-0748
DOI:10.2196/16326