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Completed

NCT Number: NCT02976376

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Box

Other

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

Primary outcomes

  1. 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

  1. Patient satisfaction of received care

    Time frame: One year

    Patient satisfaction, defined as the hight of scores derived from validated patient satisfaction questionnaire, will be measured in both groups.

  2. Major adverse cardiac events

    Time frame: One year

    Defined as cardiovascular death, recurrent STEMI, recurrent NST-ACS, revascularization, hospitalization for heart failure, TIA or ischaemic stroke

  3. Medication-adherence

    Time frame: One year

    Medication adherence is measured by validated medication adherence questionnaires. This questionnaires asks if patients take their medicines in accordance to doctors advice.

  4. Physical activity

    Time frame: One year

    Measured by the iPAQ questionnaire

  5. Quality of life

    Time frame: One year

    Measured by the validated SF-36 questionnaire

  6. Healthcare utilization

    Time frame: One year

    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

  7. Percentage of patients in which a previously unknown sustained arrhythmia (30 seconds or more) is detected

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Acronym: TheBox

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2016
Registry last updated
Dec 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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