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Myocardial Infarction, COmbined-device, Recovery Enhancement Study (MiCORE)

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: NCT03760796
Recruitment Status : Completed
First Posted : November 30, 2018
Results First Posted : February 4, 2021
Last Update Posted : July 29, 2021
Sponsor:
Collaborators:
Apple Inc.
iHealth
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

Unplanned readmissions after hospitalization for acute myocardial infarction (AMI) are among the leading causes of preventable morbidity, mortality, and healthcare costs. Digital health interventions (DHI) could be an effective tool in promoting self-management, adherence to guideline directed therapy, and cardiovascular risk reduction.

A DHI developed at Johns Hopkins-the Corrie Health Digital Platform-includes the first cardiology Apple CareKit smartphone application, paired with an Apple Watch and iHealth Bluetooth-enabled blood pressure monitor. Corrie targets: (1) self-management of cardiac medications, (2) self-tracking of vital signs, (3) education about cardiovascular disease through articles and animated videos, and (4) care coordination that includes cardiac rehabilitation and outpatient follow-up appointments.

In this prospective study, STEMI or type 1 NSTEMI patients are being enrolled to use the Corrie Health Digital Platform beginning early during participants' hospital stay. Enrollment sites include Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Massachusetts General Hospital, and Reading Hospital. The primary objective is to compare time to first readmission within 30 days post-discharge among patients with the Corrie Health Digital Platform to patients in the historical standard of care comparison group.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Coronary Artery Disease Acute Coronary Syndrome Myocardial Infarction Device: Corrie Health Digital Platform Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group assignment to the Corrie Health Digital Platform prospective intervention group (n=200), as compared with a historical standard of care comparison group (n=864)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Johns Hopkins Myocardial Infarction, COmbined-device, Recovery Enhancement (MiCORE) Study
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : December 17, 2019
Actual Study Completion Date : December 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Corrie Health Digital Platform group
Receives the Corrie Health intervention plus the standard of care
Device: Corrie Health Digital Platform
The Corrie Health Digital Platform consists of the Corrie smartphone app for heart attack recovery which is paired with an Apple Watch and Bluetooth-enabled, iHealth blood pressure monitor.




Primary Outcome Measures :
  1. Number of Participants Readmitted Within 30-days Post Hospital Discharge [ Time Frame: 30-days post hospital discharge ]
    Number of participants readmitted within 30-days post hospital discharge in the Corrie Digital Health Group as compared to the Historical Standard of Care Comparison group, collected from hospital administrative databases.


Secondary Outcome Measures :
  1. Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness [ Time Frame: 30 days post hospital discharge ]
    We estimated typical costs associated with readmissions or death of acute myocardial infarction (AMI) patients discharged with standard practices using 2014 US hospital costs from the Agency for Healthcare Research and Quality (AHRQ). The hospital cost (in US dollars) for unplanned 30-day readmission is presented for the Corrie Digital Health Platform Group and the Historical Comparison Group. The reported number is the estimated cost per readmission per participant since the exact cost of the readmission for each patient who was readmitted within 30-days wasn't available. No measure of central tendency is available.

  2. In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items) [ Time Frame: 3 days post hospital discharge ]
    Among participants in the Corrie Digital Health group, a nine-item five-point Likert scale for assessing in-hospital care satisfaction 3 days post-discharge is used with scoring from 1 "strongly disagree" to 5 "strongly agree", with higher scores meaning participants were more satisfied with the care received. A total score of these nine items is calculated with possible total scores ranging from 9 to 45.

  3. In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (Summary Score) [ Time Frame: 3 days post hospital discharge ]
    Among participants in the Corrie Digital Health group, a nine-item five-point Likert scale for assessing in-hospital care satisfaction 3 days post-discharge is used with scoring from 1 "strongly disagree" to 5 "strongly agree", with higher scores meaning participants were more satisfied with the care received. A total score of these nine items is calculated with possible total scores ranging from 9 to 45.

  4. In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Dichotomous Item) [ Time Frame: 3 days post hospital discharge ]
    Among participants in the Corrie Digital Health group, one additional item, not on the five-point Likert scale, for assessing in-hospital care satisfaction 3 days post-discharge asked if they received information in writing about what symptoms or health problems to look out for after leaving the hospital (Yes/No).

  5. In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Continuous Item) [ Time Frame: 3 days post hospital discharge ]
    Among participants in the Corrie Digital Health group, one additional item, not on the five-point Likert scale, for assessing in-hospital care satisfaction 3 days post-discharge asked them to provide an overall hospital rating on a 1-10 sliding scale with a higher score indicating a higher overall hospital rating.

  6. Perceived Usability of Corrie as Assessed by the Systems Usability Scale [ Time Frame: 3 and 30 days post hospital discharge ]
    Among participants in the Corrie Digital Health group, a 10-item five-point Likert scale for assessing systems usability of Corrie both 3 and 30 days post-discharge is used with scoring from 0 to 4 and higher scores meaning patients perceive the system as having global usability. The total score reference range is from 0 to 100, where lower scores indicate lower perceived application usability.

  7. Perceived Corrie App Satisfaction as Assessed by a Study Team Developed Scale [ Time Frame: 3 and 30 days post hospital discharge ]
    Among participants in the Corrie Digital Health group, a five-item five-point Likert scale for assessing participant satisfaction with Corrie as a tool to improve acute myocardial infarction recovery 3 and 30 days post-discharge is used with scoring from 1 to 5 and higher scores meaning more satisfaction with Corrie. Total possible scores ranging from 5 to 25, where higher scores indicate greater Corrie app satisfaction.

  8. User Engagement With Corrie App as Assessed by the User Engagement Scale [ Time Frame: 30 days post hospital discharge ]
    Among participants in the Corrie Digital Health group, a 29-item five-point Likert scale for assessing the subjective experience of user engagement with Corrie 30 days post discharge is used with scoring ranging from 1 to 5 and higher scores reflecting higher perceived user engagement. The total subjective user engagement score was calculated by diving the sum of all items by 29, resulting in a range of potential total scores from 1 to 5.

  9. User Engagement With Corrie Health App as Assessed by the Total Number of Interactions Per Participant in the Smartphone App, Collected Via Corrie Health Platform User Analytics [ Time Frame: Throughout the study period for app usage up to 30 days post-discharge from the hospital ]
    The total number of app interactions is a behavioral manifestation of user engagement and is monitored through app usage data. The total number of app interactions consisted of: number of BP, heart rate,weight, mood, and step count recordings; number of medications tracked; and number of educational articles and videos viewed over the study period.

  10. User Engagement With Corrie Health App as Assessed by the Overall Amount of Time Spent Using the App, Collected Via Corrie Health Platform App User Analytics [ Time Frame: Throughout the study period for app usage up to 30 days post-discharge from the hospital ]
    The overall amount of time (days) spent using the app is a behavioral manifestation of user engagement and is monitored through app usage data and collected via Corrie Health Platform app user analytics.

  11. Patient Activation as Assessed by the Patient Activation Measure [ Time Frame: 3 and 30 days post hospital discharge ]
    Among participants in the Corrie Digital Health group, the 10-item five-point Likert scale for assessing patient activation 3 and 30 days post-discharge is used with scoring ranging from 1 to 5 and higher scores indicating the patient possesses the necessary knowledge, skills, and confidence needed for self-care. The total score reference range is from 0 to 100, where lower scores indicate lower patient activation.

  12. Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale [ Time Frame: 30 days post hospital discharge ]
    Among participants in the Corrie Digital Health group, the eight-item four-point Likert scale for assessing cardiac medication adherence 30 days post-discharge is used with scoring ranging from 1 to 4 and lower scores indicating better adherence. Total possible scores could range from 8 to 32 with lower scores indicating better adherence. The total cardiac medication adherence score was dichotomized into completely cardiac medication adherent and near completely cardiac medication adherent, based on the median score.

  13. Cardiac Medication Adherence as Assessed by Smartphone App Usage Data [ Time Frame: Throughout the study period for app usage up to 30 days post-discharge from the hospital ]
    Cardiac medication adherence (beta-blockers, anti-platelets, statins) is measured from the smartphone app usage data as the percentage of cardiac medications marked as "taken".

  14. Medication Adherence as Assessed by Smartwatch App Usage Data [ Time Frame: Throughout the study period for app usage up to 30 days post-discharge from the hospital ]
    Medication adherence is measured from the smartwatch app usage data as percent of pills marked as taken.

  15. Number of Participants Who Had Emergency Department Visits Within 30-days Post Hospital Discharge [ Time Frame: 30 days post hospital discharge ]
    Number of participants who had Emergency department visits (at Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center) within 30-days post hospital discharge, that did not result in readmission, in the Corrie Digital Health Group as compared to the Historical Standard of Care Comparison group, collected from hospital administrative databases.

  16. Number of Hospital Observations [ Time Frame: 30 days post hospital discharge ]
    Number of hospital observations within 30-days post hospital discharge in the Corrie Digital Health Group as compared to the Historical Standard of Care Comparison group, collected from hospital administrative databases.

  17. Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team [ Time Frame: 30 days post hospital discharge ]
    Among participants in the Corrie Digital Health group, the investigators are querying participants in the surveys sent out 30 days post-discharge as to whether participants attended an appointment with a primary care provider, cardiologist, and/or cardiac rehab. A point is given to each appointment attended with scores raging from 0 to 3.

  18. Number of Readmitted Participants Who Had Recurrent Myocardial Infarctions [ Time Frame: 30 days post hospital discharge ]
    Number of readmitted participants who had Recurrent myocardial infarctions in the Corrie Digital Health Group. Participants who had an all-cause 30-day readmission in the Corrie group, as identified by hospital administrative datasets, underwent further chart review to determine if the cause of readmission was a recurrent myocardial infarction.

  19. Number of Deaths Within 30 Days Post Hospital Discharge [ Time Frame: 30 days post hospital discharge ]
    Death within 30-days post hospital discharge in the Corrie Digital Health Group as compared to the Historical Standard of Care Comparison group, collected from hospital administrative databases.



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

Corrie Health Digital Platform group

Inclusion Criteria:

  • Admitted for acute myocardial infarction (STEMI or Type 1 NSTEMI)
  • 18 years or older
  • English-speaking
  • Own any type of smartphone

Exclusion Criteria:

  • Visual, hearing, or motor impairment which precludes the use of the intervention
  • Inability to participate due to severity of illness (e.g., intubated and on sedation in the setting of cardiogenic shock). If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member returns at a later date to determine whether this status has changed.

Historical Standard of Care Comparison group

Inclusion Criteria:

  • Admitted for acute myocardial infarction (STEMI or NSTEMI)
  • 18 years or older
  • English-speaking

Exclusion Criteria:

  • None

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): NCT03760796


Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Reading Hospital-Tower Health
Reading, Pennsylvania, United States, 19611
Sponsors and Collaborators
Johns Hopkins University
Apple Inc.
iHealth
Investigators
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Principal Investigator: Seth S Martin, MD, MHS Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Informed Consent Form  [PDF] July 24, 2018

Additional Information:
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03760796    
Other Study ID Numbers: IRB00099938
First Posted: November 30, 2018    Key Record Dates
Results First Posted: February 4, 2021
Last Update Posted: July 29, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Johns Hopkins University:
readmission
cardiovascular disease prevention
cardiovascular disease risk factors
cost-effectiveness
heart attack
acute myocardial infarction
secondary prevention
digital health
smartphone app
self-management
guideline adherence
behavior modification
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Acute Coronary Syndrome
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases