N/A
N=1,064
Myocardial Infarction, COmbined-device, Recovery Enhancement Study
Acute Myocardial Infarction · Coronary Artery Disease · Acute Coronary Syndrome · Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT03760796 ↗Enrolled (actual)
1,064
Serious AEs
6.5%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants Readmitted Within 30-days Post Hospital Discharge — 13; 145 Participants — p=0.018
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Corrie Health Digital Platform (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Readmitted Within 30-days Post Hospital Discharge |
13; 145 | 0.018 sig |
| SECONDARY Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness |
17,195; 27,940 | — |
| SECONDARY In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items) |
0; 0; 3; 21; 65; 0 | — |
| SECONDARY In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (Summary Score) |
43 | — |
| SECONDARY In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Dichotomous Item) |
79; 9 | — |
| SECONDARY In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Continuous Item) |
10 | — |
| SECONDARY Perceived Usability of Corrie as Assessed by the Systems Usability Scale |
58.6; 57.6 | — |
| SECONDARY Perceived Corrie App Satisfaction as Assessed by a Study Team Developed Scale |
18.29; 17.65 | — |
| SECONDARY User Engagement With Corrie App as Assessed by the User Engagement Scale |
3.36 | — |
| SECONDARY 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 |
213 | — |
| SECONDARY 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 |
12 | — |
| SECONDARY Patient Activation as Assessed by the Patient Activation Measure |
71.9; 71.7 | — |
| SECONDARY Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale |
81; 21 | — |
| SECONDARY Cardiac Medication Adherence as Assessed by Smartphone App Usage Data |
87 | — |
| SECONDARY Medication Adherence as Assessed by Smartwatch App Usage Data |
— | — |
| SECONDARY Number of Participants Who Had Emergency Department Visits Within 30-days Post Hospital Discharge |
13; 39 | 0.33 |
| SECONDARY Number of Hospital Observations |
— | — |
| SECONDARY Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team |
34; 48; 19; 3 | — |
| SECONDARY Number of Readmitted Participants Who Had Recurrent Myocardial Infarctions |
— | — |
| SECONDARY Number of Deaths Within 30 Days Post Hospital Discharge |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03760796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.