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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Other: The Box


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Box<br>After randomization, patients in the intervention group will receive a box (The Box) with all the devices described above. Instructions about the installation and usage of the devices will be given. Patients will be asked to measure their weight and blood pressure once a day. Furthermore, patients will be asked to record an ECG using the AliveCor once a day. Moreover, they are asked to record an ECG in case of any symptoms of possible cardiac origin, as judged by the patient. All data will be automatically transferred to the Leiden University Medical Center. Lastly, two of the four outpatient clinical visits will be done via a video connection. The content of the interview will be comparable to the content of a regular outpatient clinic visit. | Other: The Box<br>* The Box contains four smartphone compatible devices. Patients will measure their vital signs and automatically send them to the hospital.<br>|
| No Intervention: Control<br>Patients who are randomized to the control group will receive regular care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year | 
| Major adverse cardiac events | Defined as cardiovascular death, recurrent STEMI, recurrent NST-ACS, revascularization, hospitalization for heart failure, TIA or ischaemic stroke | 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. | One year | 
| Physical activity | Measured by the iPAQ questionnaire | One year | 
| Quality of life | Measured by the validated SF-36 questionnaire | 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 | One year | 
| Percentage of patients in which a previously unknown sustained arrhythmia (30 seconds or more) is detected |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, e-Health, mHealth, mobile phones, smartphone, follow-up