Clinical trial NCT03760796: Myocardial Infarction, COmbined-device, Recovery Enhancement Study
Official title: The Johns Hopkins Myocardial Infarction, COmbined-device, Recovery Enhancement (MiCORE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Coronary Artery Disease
Acute Coronary Syndrome
Myocardial Infarction
Keywords: 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
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Apple Inc.
name: iHealth
First posted: 2018-11-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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)
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of Participants Readmitted Within 30-days Post Hospital Discharge
timeFrame: 30-days post hospital discharge
Secondary outcomes:
measure: Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness
timeFrame: 30 days post hospital discharge
measure: In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)
timeFrame: 3 days post hospital discharge
measure: In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (Summary Score)
timeFrame: 3 days post hospital discharge
measure: In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Dichotomous Item)
timeFrame: 3 days post hospital discharge
measure: In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Continuous Item)
timeFrame: 3 days post hospital discharge
measure: Perceived Usability of Corrie as Assessed by the Systems Usability Scale
timeFrame: 3 and 30 days post hospital discharge
measure: Perceived Corrie App Satisfaction as Assessed by a Study Team Developed Scale
timeFrame: 3 and 30 days post hospital discharge
measure: User Engagement With Corrie App as Assessed by the User Engagement Scale
timeFrame: 30 days post hospital discharge
measure: 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
timeFrame: Throughout the study period for app usage up to 30 days post-discharge from the hospital
measure: 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
timeFrame: Throughout the study period for app usage up to 30 days post-discharge from the hospital
measure: Patient Activation as Assessed by the Patient Activation Measure
timeFrame: 3 and 30 days post hospital discharge
measure: Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale
timeFrame: 30 days post hospital discharge
measure: Cardiac Medication Adherence as Assessed by Smartphone App Usage Data
timeFrame: Throughout the study period for app usage up to 30 days post-discharge from the hospital
measure: Medication Adherence as Assessed by Smartwatch App Usage Data
timeFrame: Throughout the study period for app usage up to 30 days post-discharge from the hospital
measure: Number of Participants Who Had Emergency Department Visits Within 30-days Post Hospital Discharge
timeFrame: 30 days post hospital discharge
measure: Number of Hospital Observations
timeFrame: 30 days post hospital discharge
measure: Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team
timeFrame: 30 days post hospital discharge
measure: Number of Readmitted Participants Who Had Recurrent Myocardial Infarctions
timeFrame: 30 days post hospital discharge
measure: Number of Deaths Within 30 Days Post Hospital Discharge
timeFrame: 30 days post hospital discharge
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Reading
country: United States
facility: Reading Hospital-Tower Health
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins University
name: Seth S Martin, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spaulding EM, Marvel FA, Lee MA, Yang WE, Demo R, Wang J, Xun H, Shah L, Weng D, Fashanu OE, Carter J, Sheidy J, McLin R, Flowers J, Majmudar M, Elgin E, Vilarino V, Lumelsky D, Bhardwaj V, Padula W, Allen JK, Martin SS. Corrie Health Digital Platform for Self-Management in Secondary Prevention After Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005509. doi: 10.1161/CIRCOUTCOMES.119.005509.
citation: Shah LM, Yang WE, Demo RC, Lee MA, Weng D, Shan R, Wongvibulsin S, Spaulding EM, Marvel FA, Martin SS. Technical Guidance for Clinicians Interested in Partnering With Engineers in Mobile Health Development and Evaluation. JMIR Mhealth Uhealth. 2019 May 15;7(5):e14124. doi: 10.2196/14124.
citation: Marvel FA, Wang J, Martin SS. Digital Health Innovation: A Toolkit to Navigate From Concept to Clinical Testing. JMIR Cardio. 2018 Jan 18;2(1):e2. doi: 10.2196/cardio.7586.
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citation: Shan R, Ding J, Weng D, Spaulding EM, Wongvibulsin S, Lee MA, Demo R, Marvel FA, Martin SS. Early blood pressure assessment after acute myocardial infarction: Insights using digital health technology. Am J Prev Cardiol. 2020 Sep;3:100089. doi: 10.1016/j.ajpc.2020.100089. Epub 2020 Sep 17.
citation: Yang WE, Spaulding EM, Lumelsky D, Hung G, Huynh PP, Knowles K, Marvel FA, Vilarino V, Wang J, Shah LM, Xun H, Shan R, Wongvibulsin S, Martin SS. Strategies for the Successful Implementation of a Novel iPhone Loaner System (iShare) in mHealth Interventions: Prospective Study. JMIR Mhealth Uhealth. 2019 Dec 16;7(12):e16391. doi: 10.2196/16391.
citation: Hung G, Yang WE, Marvel FA, Martin SS. Mobile health application platform 'Corrie' personalises and empowers the heart attack recovery patient experience in the hospital and at home for an underserved heart attack survivor. BMJ Case Rep. 2020 Feb 17;13(2):e231801. doi: 10.1136/bcr-2019-231801.
citation: Marvel FA, Spaulding EM, Lee MA, Yang WE, Demo R, Ding J, Wang J, Xun H, Shah LM, Weng D, Carter J, Majmudar M, Elgin E, Sheidy J, McLin R, Flowers J, Vilarino V, Lumelsky DN, Bhardwaj V, Padula WV, Shan R, Huynh PP, Wongvibulsin S, Leung C, Allen JK, Martin SS. Digital Health Intervention in Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2021 Jul;14(7):e007741. doi: 10.1161/CIRCOUTCOMES.121.007741. Epub 2021 Jul 15.
citation: Bhardwaj V, Spaulding EM, Marvel FA, LaFave S, Yu J, Mota D, Lorigiano TJ, Huynh PP, Shan R, Yesantharao PS, Lee MA, Yang WE, Demo R, Ding J, Wang J, Xun H, Shah L, Weng D, Wongvibulsin S, Carter J, Sheidy J, McLin R, Flowers J, Majmudar M, Elgin E, Vilarino V, Lumelsky D, Leung C, Allen JK, Martin SS, Padula WV. Cost-effectiveness of a Digital Health Intervention for Acute Myocardial Infarction Recovery. Med Care. 2021 Nov 1;59(11):1023-1030. doi: 10.1097/MLR.0000000000001636.