The Johns Hopkins Myocardial Infarction, COmbined-device, Recovery Enhancement (MiCORE) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Myocardial Infarction
- Sponsor
- Johns Hopkins University
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- Number of Participants Readmitted Within 30-days Post Hospital Discharge
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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:
Outcomes
Primary Outcomes
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 Outcomes
- In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Continuous Item)(3 days post hospital discharge)
- Perceived Corrie App Satisfaction as Assessed by a Study Team Developed Scale(3 and 30 days post hospital discharge)
- User Engagement With Corrie App as Assessed by the User Engagement Scale(30 days post hospital discharge)
- 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(Throughout the study period for app usage up to 30 days post-discharge from the hospital)
- Number of Readmitted Participants Who Had Recurrent Myocardial Infarctions(30 days post hospital discharge)
- In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (Summary Score)(3 days post hospital discharge)
- In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Dichotomous Item)(3 days post hospital discharge)
- Perceived Usability of Corrie as Assessed by the Systems Usability Scale(3 and 30 days post hospital discharge)
- Cardiac Medication Adherence as Assessed by Smartphone App Usage Data(Throughout the study period for app usage up to 30 days post-discharge from the hospital)
- Number of Participants Who Had Emergency Department Visits Within 30-days Post Hospital Discharge(30 days post hospital discharge)
- Number of Deaths Within 30 Days Post Hospital Discharge(30 days post hospital discharge)
- Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness(30 days post hospital discharge)
- In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)(3 days post hospital discharge)
- 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(Throughout the study period for app usage up to 30 days post-discharge from the hospital)
- Patient Activation as Assessed by the Patient Activation Measure(3 and 30 days post hospital discharge)
- Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale(30 days post hospital discharge)
- Medication Adherence as Assessed by Smartwatch App Usage Data(Throughout the study period for app usage up to 30 days post-discharge from the hospital)
- Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team(30 days post hospital discharge)
- Number of Hospital Observations(30 days post hospital discharge)