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

NCT ID: NCT02976376

Last Updated: 2018-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-12
• Study Completion Date: 2018-11-09

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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

The Box

Intervention Type: OTHER

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

Control

Patients who are randomized to the control group will receive regular care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The Box

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

RoderickTreskes

BSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Leiden University Medical Center

Leiden, South Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 35468091 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32297946 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28939546 (View on PubMed)

Other Identifiers

P16.070

Identifier Type: -

Identifier Source: org_study_id