The Box: Using Smart Technology to Improve One-year Outcome of Myocardial Infarction Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myocardial Infarction
- Sponsor
- Leiden University Medical Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Controlled Blood pressure
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
RoderickTreskes
BSc
Leiden University Medical Center
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
Outcomes
Primary Outcomes
Controlled Blood pressure
Time Frame: One year
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
Secondary Outcomes
- Patient satisfaction of received care(One year)
- Major adverse cardiac events(One year)
- Percentage of patients in which a previously unknown sustained arrhythmia (30 seconds or more) is detected(One year)
- Physical activity(One year)
- Healthcare utilization(One year)
- Medication-adherence(One year)
- Quality of life(One year)