<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02976376</url>
  </required_header>
  <id_info>
    <org_study_id>P16.070</org_study_id>
    <nct_id>NCT02976376</nct_id>
  </id_info>
  <brief_title>The Box: Using Smart Technology to Improve One-year Outcome of Myocardial Infarction Patients</brief_title>
  <acronym>TheBox</acronym>
  <official_title>The Box: Using Smart Technology to Improve One-year Outcome of Myocardial Infarction Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Leiden University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study to investigate whether a smart technology intervention can improve clinical and&#xD;
      cost-effectiveness of one-year follow-up in patients who suffered from acute myocardial&#xD;
      infarction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Smart technology could improve quality of care in patients after acute myocardial&#xD;
      infarction (AMI) with either ST or non-ST elevation.&#xD;
&#xD;
      Objective: The objective of this study is to measure the effect of a smart technology&#xD;
      intervention on patients after AMI.&#xD;
&#xD;
      Study design: The design of the study is a single-center, open randomized-controlled trial.&#xD;
&#xD;
      Study population: The study population consists of patients who have been discharged from the&#xD;
      ward of the cardiology department of the Leiden University Medical Center after primary&#xD;
      percutaneous coronary intervention (PCI) for either ST or non-ST elevation myocardial&#xD;
      infarction.&#xD;
&#xD;
      Intervention: Patients will be randomized to either &quot;The Box&quot; or regular follow-up. Patients&#xD;
      who have been randomized to The Box will receive a box containing a smartphone compatible&#xD;
      electrocardiogram (ECG) monitor, a weight scale, an activity tracker and a blood pressure&#xD;
      monitor. If patients are randomized to The Box, two of the four outpatient clinic visits will&#xD;
      be replaced by an e-consult, in which a patient does not have to go to the hospital, but&#xD;
      talks with his or her doctor or nurse practitioner via a secured video connection.&#xD;
&#xD;
      Main study parameters/endpoints: The primary endpoint of the study will be the percentage of&#xD;
      patients with controlled blood pressure in both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 12, 2016</start_date>
  <completion_date type="Actual">November 9, 2018</completion_date>
  <primary_completion_date type="Actual">November 9, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Controlled Blood pressure</measure>
    <time_frame>One year</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction of received care</measure>
    <time_frame>One year</time_frame>
    <description>Patient satisfaction, defined as the hight of scores derived from validated patient satisfaction questionnaire, will be measured in both groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac events</measure>
    <time_frame>One year</time_frame>
    <description>Defined as cardiovascular death, recurrent STEMI, recurrent NST-ACS, revascularization, hospitalization for heart failure, TIA or ischaemic stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication-adherence</measure>
    <time_frame>One year</time_frame>
    <description>Medication adherence is measured by validated medication adherence questionnaires. This questionnaires asks if patients take their medicines in accordance to doctors advice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>One year</time_frame>
    <description>Measured by the iPAQ questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>One year</time_frame>
    <description>Measured by the validated SF-36 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilization</measure>
    <time_frame>One year</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients in which a previously unknown sustained arrhythmia (30 seconds or more) is detected</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>The Box</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After randomization, patients in the intervention group will receive a box (&quot;The Box&quot;) 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients who are randomized to the control group will receive regular care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The Box</intervention_name>
    <description>The Box contains four smartphone compatible devices. Patients will measure their vital signs and automatically send them to the hospital.</description>
    <arm_group_label>The Box</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is admitted with acute myocardial infarction&#xD;
&#xD;
          -  Patient is able to communicate in English or Dutch at B1 level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index &gt; 35 kg x m-2&#xD;
&#xD;
          -  Included in another randomized controlled trial&#xD;
&#xD;
          -  Patient is &lt;18 years of age&#xD;
&#xD;
          -  Patient is considered an incapacitated adult&#xD;
&#xD;
          -  Patient is pregnant&#xD;
&#xD;
          -  Patient is unwilling to sign the informed consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <state>Zuid-Holland</state>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
    <investigator_full_name>RoderickTreskes</investigator_full_name>
    <investigator_title>BSc</investigator_title>
  </responsible_party>
  <keyword>Myocardial infarction</keyword>
  <keyword>e-Health</keyword>
  <keyword>mHealth</keyword>
  <keyword>mobile phones</keyword>
  <keyword>smartphone</keyword>
  <keyword>follow-up</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02976376
org study id: P16.070
nct id: NCT02976376
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Controlled Blood pressure
time frame: One year
description: 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
measure: Patient satisfaction of received care
time frame: One year
description: Patient satisfaction, defined as the hight of scores derived from validated patient satisfaction questionnaire, will be measured in both groups.
measure: Major adverse cardiac events
time frame: One year
description: Defined as cardiovascular death, recurrent STEMI, recurrent NST-ACS, revascularization, hospitalization for heart failure, TIA or ischaemic stroke
measure: Medication-adherence
time frame: One year
description: Medication adherence is measured by validated medication adherence questionnaires. This questionnaires asks if patients take their medicines in accordance to doctors advice.
measure: Physical activity
time frame: One year
description: Measured by the iPAQ questionnaire
measure: Quality of life
time frame: One year
description: Measured by the validated SF-36 questionnaire
measure: Healthcare utilization
time frame: One year
description: 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
measure: Percentage of patients in which a previously unknown sustained arrhythmia (30 seconds or more) is detected
time frame: One year
arm group label: The Box
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: No Intervention
description: Patients who are randomized to the control group will receive regular care.
intervention type: Other
intervention name: The Box
description: The Box contains four smartphone compatible devices. Patients will measure their vital signs and automatically send them to the hospital.
arm group label: The Box
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Leiden University Medical Center
investigator full name: RoderickTreskes
investigator title: BSc
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: Undecided