NCT02976376

The Box: Using Smart Technology to Improve One-year Outcome of Myocardial Infarction Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to investigate whether a smart technology intervention can improve clinical and cost-effectiveness of one-year follow-up in patients who suffered from acute myocardial infarction.

Detailed description

Rationale: Smart technology could improve quality of care in patients after acute myocardial infarction (AMI) with either ST or non-ST elevation. Objective: The objective of this study is to measure the effect of a smart technology intervention on patients after AMI. Study design: The design of the study is a single-center, open randomized-controlled trial. Study population: The study population consists of patients who have been discharged from the ward of the cardiology department of the Leiden University Medical Center after primary percutaneous coronary intervention (PCI) for either ST or non-ST elevation myocardial infarction. Intervention: Patients will be randomized to either "The Box" or regular follow-up. Patients who have been randomized to The Box will receive a box containing a smartphone compatible electrocardiogram (ECG) monitor, a weight scale, an activity tracker and a blood pressure monitor. If patients are randomized to The Box, two of the four outpatient clinic visits will be replaced by an e-consult, in which a patient does not have to go to the hospital, but talks with his or her doctor or nurse practitioner via a secured video connection. Main study parameters/endpoints: The primary endpoint of the study will be the percentage of patients with controlled blood pressure in both groups.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
OTHER	The Box	The Box contains four smartphone compatible devices. Patients will measure their vital signs and automatically send them to the hospital.

Timeline

• Start date: 2016-05-12
• Primary completion: 2018-11-09
• Completion: 2018-11-09
• First posted: 2016-11-29
• Last updated: 2018-12-06

Locations

1 site across 1 country: Netherlands