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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Other: The Box

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Leiden University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Box; 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; The Box contains four smartphone compatible devices. Patients will measure their vital signs and automatically send them to the hospital.
No Intervention: Control; Patients who are randomized to the control group will receive regular care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Leiden University Medical Center

Publications and helpful links

General Publications

• Treskes RW, van den Akker-van Marle ME, van Winden L, van Keulen N, van der Velde ET, Beeres S, Atsma D, Schalij MJ. The Box-eHealth in the Outpatient Clinic Follow-up of Patients With Acute Myocardial Infarction: Cost-Utility Analysis. J Med Internet Res. 2022 Apr 25;24(4):e30236. doi: 10.2196/30236.
• Treskes RW, van Winden LAM, van Keulen N, van der Velde ET, Beeres SLMA, Atsma DE, Schalij MJ. Effect of Smartphone-Enabled Health Monitoring Devices vs Regular Follow-up on Blood Pressure Control Among Patients After Myocardial Infarction: A Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e202165. doi: 10.1001/jamanetworkopen.2020.2165.
• Treskes RW, van Winden LA, van Keulen N, Atsma DE, van der Velde ET, van den Akker-van Marle E, Mertens B, Schalij MJ. Using Smart Technology to Improve Outcomes in Myocardial Infarction Patients: Rationale and Design of a Protocol for a Randomized Controlled Trial, The Box. JMIR Res Protoc. 2017 Sep 22;6(9):e186. doi: 10.2196/resprot.8038.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2016
• Primary Completion (Actual): November 9, 2018
• Study Completion (Actual): November 9, 2018

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: November 24, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Myocardial infarction; follow-up; smartphone; mHealth; mobile phones; e-Health
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: P16.070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED