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

Myocardial Infarction Clinical Trial

— TheBox  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976376
• Other study ID #: P16.070
• Status: Completed
• Phase: N/A
• Start date: May 12, 2016
• Est. completion date: November 9, 2018

Study information

• Verified date: December 2018
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 9, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• The Box
The Box contains four smartphone compatible devices. Patients will measure their vital signs and automatically send them to the hospital.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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