Clinical trial NCT02976376: The Box: Using Smart Technology to Improve One-year Outcome of Myocardial Infarction Patients
Official title: The Box: Using Smart Technology to Improve One-year Outcome of Myocardial Infarction Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: Myocardial infarction
e-Health
mHealth
mobile phones
smartphone
follow-up
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patient is admitted with acute myocardial infarction
* Patient is able to communicate in English or Dutch at B1 level

Exclusion Criteria:

* Body Mass Index \> 35 kg x m-2
* Included in another randomized controlled trial
* Patient is \<18 years of age
* Patient is considered an incapacitated adult
* Patient is pregnant
* Patient is unwilling to sign the informed consent form

Primary outcomes:
measure: Controlled Blood pressure
timeFrame: One year
Secondary outcomes:
measure: Patient satisfaction of received care
timeFrame: One year
measure: Major adverse cardiac events
timeFrame: One year
measure: Medication-adherence
timeFrame: One year
measure: Physical activity
timeFrame: One year
measure: Quality of life
timeFrame: One year
measure: Healthcare utilization
timeFrame: One year
measure: Percentage of patients in which a previously unknown sustained arrhythmia (30 seconds or more) is detected
timeFrame: One year
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
References:
citation: Treskes RW, van den Akker-van Marle ME, van Winden L, van Keulen N, van der Velde ET, Beeres S, Atsma D, Schalij MJ. The Box-eHealth in the Outpatient Clinic Follow-up of Patients With Acute Myocardial Infarction: Cost-Utility Analysis. J Med Internet Res. 2022 Apr 25;24(4):e30236. doi: 10.2196/30236.
citation: Treskes RW, van Winden LAM, van Keulen N, van der Velde ET, Beeres SLMA, Atsma DE, Schalij MJ. Effect of Smartphone-Enabled Health Monitoring Devices vs Regular Follow-up on Blood Pressure Control Among Patients After Myocardial Infarction: A Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e202165. doi: 10.1001/jamanetworkopen.2020.2165.
citation: Treskes RW, van Winden LA, van Keulen N, Atsma DE, van der Velde ET, van den Akker-van Marle E, Mertens B, Schalij MJ. Using Smart Technology to Improve Outcomes in Myocardial Infarction Patients: Rationale and Design of a Protocol for a Randomized Controlled Trial, The Box. JMIR Res Protoc. 2017 Sep 22;6(9):e186. doi: 10.2196/resprot.8038.