NCT03690492

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

Completed NA Last updated 8 September 2021

What this trial tests

NA trial testing The Box 2.0 in Rehabilitation After Cardiovascular Surgery in 730 participants. Completed in 15 June 2021.

Timeline

2 October 2018

Primary endpoint
15 March 2021

15 June 2021

Quick facts

Lead sponsor	Leiden University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	730
Start date	2 October 2018
Primary completion	15 March 2021
Estimated completion	15 June 2021
Sites	1 location across Netherlands

Drugs / interventions tested

• The Box 2.0

Conditions studied

• Rehabilitation After Cardiovascular Surgery — all drugs for Rehabilitation After Cardiovascular Surgery →
• Mobile Health — all drugs for Mobile Health →

Sponsor

Leiden University Medical Center

Who can join

18 and older, any sex, with Rehabilitation After Cardiovascular Surgery or Mobile Health. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Use of Smart Technology for the Early Diagnosis of Complications After Cardiac Surgery: The Box 2.0 Study Protocol.
   Biersteker TE, Boogers MJ, de Lind van Wijngaarden RA, Groenwold RH, et al · · 2020 · cited 11× · PMID 32314974 · DOI 10.2196/16326
2. Mobile health vs. standard care after cardiac surgery: results of The Box 2.0 study.
   Biersteker TE, Boogers MJ, Schalij MJ, Penning de Vries BBL, et al · · 2023 · cited 8× · PMID 35951658 · DOI 10.1093/europace/euac115
3. Real-World Experience of mHealth Implementation in Clinical Practice (the Box): Design and Usability Study.
   Biersteker T, Hilt A, van der Velde E, Schalij MJ, et al · · 2021 · cited 4× · PMID 34642159 · DOI 10.2196/26072
4. Mobile health for cardiovascular risk management after cardiac surgery: results of a sub-analysis of The Box 2.0 study.
   Biersteker TE, Boogers MJ, Schalij MJ, Braun J, et al · · 2023 · PMID 37538141 · DOI 10.1093/ehjdh/ztad035