The Box 2.0: Using Smart Technology for Early Diagnosis of Complications After Cardiovascular Surgery

NCT03690492 | Completed

• 1 other identifier: NL65959.058.18
• Study Type: interventional
• Target: 730
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the effect on quality of care when introducing smart technology in patients who underwent cardiovascular surgery. Patients who consent to take part in the study, receive a box containing two smartphone compatible ECG monitors, an oxygen saturation monitor, a weight scale, a thermometer, an activity tracker and a blood pressure monitor. They will be followed up by replacing one of the outpatient clinic visits by an e-consult, in which a patients does not have to go to the hospital. Instead, he or she will talk with his or her doctor or nurse practitioner via a secured video connection. The primary endpoint of the study will be the diagnosis of atrial fibrillation within 3 months after cardiac surgery.

Conditions

Rehabilitation After Cardiovascular Surgery; Mobile Health

Outcome Measures

Primary Outcomes (1)

• Dectection of and time to detection of atrial fibrillation

  Diagnosis of atrial fibrillation and the time it took a subject to reach that outcome, measured in both study arms

  Until 3 months after surgery

Secondary Outcomes (10)

• Dectection of and time to detection of cardiac decompensation

  Until 3 months after surgery

• Quality of Life (QoL)

  3 months after surgery

• Patient satisfaction of care

  3 months after surgery

• Overall mortality

  3 months after surgery

• Major adverse cardiac events

  Until 3 months after surgery

Study Arms (2)

The Box 2.0

EXPERIMENTAL

Patients will be given a Box, in which they will find a thermometer, blood pressure monitor, activity tracker, weight scale, blood oxygen saturation monitor, a single lead ECG device and a four lead ECG device. Also, they will be followed-up by use of two webcam consultations instead of a normal outpatient clinic visit.

Other: The Box 2.0

Controls

NO INTERVENTION

Patients will not receive a Box. They will be followed up by standard care, returning to the outpatient clinic at the same frequency and timing as The Box 2.0 arm.

Interventions

The Box 2.0 OTHER

Patients in the intervention arm will receive a Box with several devices that is hypothesized to allow for better and earlier detection of complications after cardiac surgery.

The Box 2.0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoes cardiovascular surgery: CABG, valve reconstruction or replacement, aortic root or ascending aortic surgery, or any other cardiothoracic surgery performed by median sternotomy such as atrial or ventricular septal defect closure, Dor or Morrow procedure, cardiac tumor removal and/or surgical treatment of coronary artery anomalies.
• Patient is able to communicate in English or Dutch
• Patient has been referred by a cardiologist from the Leiden University Medical Center, Cardiological Center Voorschoten, Alrijne Hospital or Haaglanden Medical Center

You may not qualify if:

• Patient is \< 18 years old
• Patient is pregnant
• Patient is considered an incapacitated adult
• Patient is unwilling to sign the informed consent form
• Patient undergoes emergency thoracic surgery (INTERMACS 1 or 2)
• Patient has active endocarditis at the time of operation
• Patient is on mechanical circulatory support before operation
• Patient has a ventricular septal rupture
• Patient undergoes extracorporeal membrane oxygenation or ventricular assist device insertion

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Centre

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (1)

• Biersteker TE, Boogers MJ, de Lind van Wijngaarden RA, Groenwold RH, Trines SA, van Alem AP, Kirchhof CJ, van Hof N, Klautz RJ, Schalij MJ, Treskes RW. Use of Smart Technology for the Early Diagnosis of Complications After Cardiac Surgery: The Box 2.0 Study Protocol. JMIR Res Protoc. 2020 Apr 21;9(4):e16326. doi: 10.2196/16326.

  PMID: 32314974 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 1, 2018
• Study Start: October 2, 2018
• Primary Completion: March 15, 2021
• Study Completion: June 15, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)