An interventional study of The Box in Myocardial Infarction, sponsored by Leiden University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-06.
Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Prevention
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 200 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Patients who are randomized to the control group will receive regular care.
The Box contains four smartphone compatible devices. Patients will measure their vital signs and automatically send them to the hospital.
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
Percentage of patients in which a previously unknown sustained arrhythmia (30 seconds or more) is detected
Time frame: One year
Plan to share: Undecided
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Leiden University Medical Center