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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
The Box contains four smartphone compatible devices. Patients will measure their vital signs and automatically send them to the hospital.
Leiden University Medical Center
Leiden, South Holland, Netherlands
Controlled Blood pressure
A blood pressure is considered controlled if the average of three measurements is below 140 (systolic) and 90 (diastolic) after 12 months of follow-up
Time frame: One year
Patient satisfaction of received care
Patient satisfaction, defined as the hight of scores derived from validated patient satisfaction questionnaire, will be measured in both groups.
Time frame: One year
Major adverse cardiac events
Defined as cardiovascular death, recurrent STEMI, recurrent NST-ACS, revascularization, hospitalization for heart failure, TIA or ischaemic stroke
Time frame: One year
Medication-adherence
Medication adherence is measured by validated medication adherence questionnaires. This questionnaires asks if patients take their medicines in accordance to doctors advice.
Time frame: One year
Physical activity
Measured by the iPAQ questionnaire
Time frame: One year
Quality of life
Measured by the validated SF-36 questionnaire
Time frame: One year
Healthcare utilization
Defined as the number of hospital visits, defined as an outpatient clinic visit, emergency care visit or admission for any reason. This will be measured via questionnaires and verified by EMR data
Time frame: One year
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Percentage of patients in which a previously unknown sustained arrhythmia (30 seconds or more) is detected
Time frame: One year