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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02976376
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
RoderickTreskes, Leiden University Medical Center

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Other: The Box Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Box: Using Smart Technology to Improve One-year Outcome of Myocardial Infarction Patients
Actual Study Start Date : May 12, 2016
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976376


Locations
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Netherlands
Leiden University Medical Center
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Sponsors and Collaborators
Leiden University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RoderickTreskes, BSc, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02976376    
Other Study ID Numbers: P16.070
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by RoderickTreskes, Leiden University Medical Center:
Myocardial infarction
e-Health
mHealth
mobile phones
smartphone
follow-up
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases