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

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ClinicalTrials.gov Identifier: NCT03760796
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
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 cuff. 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 outpatient follow-up appointments.

In this prospective study, STEMI or type 1 NSTEMI patients are being enrolled to use the Corrie Digital Health 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 Digital Health 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 Digital Health platform Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 950 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Corrie Digital Health Platform prospective intervention group, as compared with historical standard of care comparison group
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, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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




Primary Outcome Measures :
  1. Time to first readmission [ Time Frame: 30-days post hospital discharge ]
    Time to first readmission 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 ]
    A Markov Model of cost-effectiveness will be built, based on 30-day readmission rates, to assess the Incremental Cost-Effectiveness Ratio of adopting the Corrie Digital Health Platform

  2. In-hospital care satisfaction as assessed by a subset of the Hospital Consumer Assessment of Healthcare Providers and Systems survey [ 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 to 5 with higher scores meaning participants were more satisfied with the care received.

  3. Change in 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 with higher scores meaning patients perceive the system as having global usability.

  4. Change in 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 AMI recovery 3 and 30 days post-discharge is used with scoring from 1 to 5 with higher scores meaning more satisfaction with Corrie.

  5. 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 31-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 with higher scores reflecting higher perceived user engagement.

  6. User engagement with Corrie Health app as assessed by the number of times the app transitions to the foreground of the smartphone or smartwatch, 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 number of times the app transitions to the foreground is a behavioral manifestation of user engagement and is monitored through app usage data.

  7. User engagement with Corrie Health app as assessed by the overall amount of time spent on 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 (minutes) spent on the app is a behavioral manifestation of user engagement and is monitored through app usage data.

  8. Change in 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 with higher scores indicating the patient possesses the necessary knowledge, skills, and confidence needed for self-care.

  9. 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 with lower scores indicating better adherence.

  10. 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 ]
    Medication adherence is measured from the smartphone app usage data as percent of pills marked as taken.

  11. 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.

  12. Number of Emergency department visits [ Time Frame: 30 days post hospital discharge ]
    Among participants in the Corrie Digital Health group, electronic medical records are reviewed 30 days post-discharge to assess for whether a participant had an emergency department visit

  13. Attendance of follow-up appointments as assessed by post discharge survey 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. Follow-up appointment scheduling is also measured via app usage data.

  14. Number of Recurrent myocardial infarctions [ Time Frame: 30 days post hospital discharge ]
    Recurrent myocardial infarction 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

  15. 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



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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 Digital Health 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:


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


Contacts
Contact: Seth S Martin, MD, MHS 410-502-0469 smart100@jhmi.edu
Contact: Erin M Spaulding, BSN, PhDc espauld2@jhu.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Seth Martin, MD, MHS         
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Seth Martin, MD, MHS         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jocelyn Carter, MD         
United States, Pennsylvania
Reading Hospital-Tower Health Recruiting
Reading, Pennsylvania, United States, 19611
Contact: Mary Alderfer         
Sponsors and Collaborators
Johns Hopkins University
Apple Inc.
iHealth
Investigators
Principal Investigator: Seth S Martin, MD, MHS Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03760796     History of Changes
Other Study ID Numbers: IRB00099938
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

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:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases