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Myocardial Infarction, COmbined-device, Recovery Enhancement Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03760796
Acronym
MiCORE
Enrollment
200
Registered
2018-11-30
Start date
2016-10-01
Completion date
2019-12-17
Last updated
2021-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Acute Myocardial Infarction, Coronary Artery Disease, 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

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.

Interventions

DEVICECorrie 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.

Sponsors

Apple Inc.
CollaboratorINDUSTRY
iHealth
CollaboratorOTHER
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

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)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Readmitted Within 30-days Post Hospital Discharge30-days post hospital dischargeNumber 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

MeasureTime frameDescription
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 dischargeAmong 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.
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 dischargeAmong 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.
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 dischargeAmong 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).
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 dischargeAmong 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.
Perceived Usability of Corrie as Assessed by the Systems Usability Scale3 and 30 days post hospital dischargeAmong 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.
Perceived Corrie App Satisfaction as Assessed by a Study Team Developed Scale3 and 30 days post hospital dischargeAmong 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.
User Engagement With Corrie App as Assessed by the User Engagement Scale30 days post hospital dischargeAmong 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.
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 AnalyticsThroughout the study period for app usage up to 30 days post-discharge from the hospitalThe 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.
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 AnalyticsThroughout the study period for app usage up to 30 days post-discharge from the hospitalThe 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.
Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness30 days post hospital dischargeWe 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.
Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale30 days post hospital dischargeAmong 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.
Cardiac Medication Adherence as Assessed by Smartphone App Usage DataThroughout the study period for app usage up to 30 days post-discharge from the hospitalCardiac medication adherence (beta-blockers, anti-platelets, statins) is measured from the smartphone app usage data as the percentage of cardiac medications marked as taken.
Medication Adherence as Assessed by Smartwatch App Usage DataThroughout the study period for app usage up to 30 days post-discharge from the hospitalMedication adherence is measured from the smartwatch app usage data as percent of pills marked as taken.
Number of Participants Who Had Emergency Department Visits Within 30-days Post Hospital Discharge30 days post hospital dischargeNumber 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.
Number of Hospital Observations30 days post hospital dischargeNumber 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.
Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team30 days post hospital dischargeAmong 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.
Number of Readmitted Participants Who Had Recurrent Myocardial Infarctions30 days post hospital dischargeNumber 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.
Number of Deaths Within 30 Days Post Hospital Discharge30 days post hospital dischargeDeath 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.
Patient Activation as Assessed by the Patient Activation Measure3 and 30 days post hospital dischargeAmong 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.

Countries

United States

Participant flow

Recruitment details

200 participants were enrolled in 4 hospitals to receive study intervention. 864 patients' data were pulled from hospital administrative data sets to be the historical comparison group.

Pre-assignment details

Patients in the historical comparison group were not considered enrolled in this study.

Participants by arm

ArmCount
Corrie Digital Health Platform Group
Receives the Corrie Digital Health intervention plus the standard of care 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.
200
Historical Comparison Group
Receives the standard of care
864
Total1,064

Baseline characteristics

CharacteristicCorrie Digital Health Platform GroupHistorical Comparison GroupTotal
Age, Continuous59.2 years
STANDARD_DEVIATION 11.5
65.4 years
STANDARD_DEVIATION 14.1
64.3 years
STANDARD_DEVIATION 13.9
Body mass index30.6 kg/m^2
STANDARD_DEVIATION 5.9
29.5 kg/m^2
STANDARD_DEVIATION 8.2
29.7 kg/m^2
STANDARD_DEVIATION 7.9
Discharge disposition
AMA/shelters/police custody/unknown
0 Participants15 Participants15 Participants
Discharge disposition
Home
167 Participants555 Participants722 Participants
Discharge disposition
Home care
18 Participants182 Participants200 Participants
Discharge disposition
Hospice/other hospital
2 Participants46 Participants48 Participants
Discharge disposition
Rehabilitation
12 Participants22 Participants34 Participants
Discharge disposition
Skilled nursing facility
1 Participants44 Participants45 Participants
Duration of education14.6 years
STANDARD_DEVIATION 3.6
14.6 years
STANDARD_DEVIATION 3.6
Hospital of Admission
Johns Hopkins Bayview Medical Center
70 Participants297 Participants367 Participants
Hospital of Admission
Johns Hopkins Hospital
104 Participants437 Participants541 Participants
Hospital of Admission
Massachusetts General Hospital
14 Participants70 Participants84 Participants
Hospital of Admission
Reading Hospital
12 Participants60 Participants72 Participants
Household income per year70,000 US dollars70,000 US dollars
Insurance status
Medicaid
22 Participants45 Participants67 Participants
Insurance status
Medicare
62 Participants428 Participants490 Participants
Insurance status
Private insurance/PPO/HMO
110 Participants348 Participants458 Participants
Insurance status
Self-pay
6 Participants11 Participants17 Participants
Insurance status
Unknown
0 Participants32 Participants32 Participants
Intervention (during index admission)
Both
8 Participants4 Participants12 Participants
Intervention (during index admission)
Coronary artery bypass grafting surgery alone
44 Participants134 Participants178 Participants
Intervention (during index admission)
Neither
17 Participants406 Participants423 Participants
Intervention (during index admission)
Percutaneous coronary intervention alone
131 Participants320 Participants451 Participants
Length of stay5 days4 days4 days
Marital status
Married
117 Participants359 Participants476 Participants
Marital status
Not married
77 Participants465 Participants542 Participants
Marital status
Unknown
6 Participants40 Participants46 Participants
Race/Ethnicity, Customized
Race
Non-White
57 Participants285 Participants342 Participants
Race/Ethnicity, Customized
Race
Unknown
6 Participants18 Participants24 Participants
Race/Ethnicity, Customized
Race
White
137 Participants561 Participants698 Participants
Sex: Female, Male
Female
58 Participants336 Participants394 Participants
Sex: Female, Male
Male
142 Participants528 Participants670 Participants
Smoking status
Current smoker
57 Participants193 Participants250 Participants
Smoking status
Former smoker
53 Participants284 Participants337 Participants
Smoking status
Never smoker
90 Participants273 Participants363 Participants
Total Elixhauser comorbidity count3 Number of comorbidities per patient4 Number of comorbidities per patient4 Number of comorbidities per patient
Type of Acute Myocardial Infarction
NSTEMI
121 Participants676 Participants797 Participants
Type of Acute Myocardial Infarction
STEMI
79 Participants188 Participants267 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
1 / 200
other
Total, other adverse events
1 / 200
serious
Total, serious adverse events
13 / 200

Outcome results

Primary

Number of Participants Readmitted Within 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.

Time frame: 30-days post hospital discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Corrie Digital Health Platform GroupNumber of Participants Readmitted Within 30-days Post Hospital Discharge13 Participants
Historical Comparison GroupNumber of Participants Readmitted Within 30-days Post Hospital Discharge145 Participants
p-value: 0.01895% CI: [0.26, 0.88]Regression, Cox
Secondary

Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team

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.

Time frame: 30 days post hospital discharge

Population: 104 participants completed this survey question at 30 days post-discharge.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Corrie Digital Health Platform GroupAttendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team3 appointments attended34 Participants
Corrie Digital Health Platform GroupAttendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team2 appointments attended48 Participants
Corrie Digital Health Platform GroupAttendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team1 appointment attended19 Participants
Corrie Digital Health Platform GroupAttendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team0 appointments attended3 Participants
Secondary

Cardiac Medication Adherence as Assessed by Smartphone App Usage Data

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.

Time frame: Throughout the study period for app usage up to 30 days post-discharge from the hospital

Population: 135 patients who had app interaction data specific to cardiovascular disease (CVD) medications (beta-blocker, anti-platelet, statin) from admission through 30 days post-discharge.

ArmMeasureValue (NUMBER)
Corrie Digital Health Platform GroupCardiac Medication Adherence as Assessed by Smartphone App Usage Data87 percentage of any CVD meds marked taken
Secondary

Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale

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.

Time frame: 30 days post hospital discharge

Population: 102 participants completed the survey at 30 days post-discharge.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Corrie Digital Health Platform GroupCardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale SubscaleComplete Adherence81 Participants
Corrie Digital Health Platform GroupCardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale SubscaleNear Complete Adherence21 Participants
Secondary

Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness

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.

Time frame: 30 days post hospital discharge

Population: 200 patients enrolled in the Corrie group as compared to data from the historical comparison group as well as model estimates obtained from the literature for the standard of care comparison. Model estimates from the literature were used to supplement information when data was not available from the historical comparison group. The addition of the model estimates from the literature ensured the testing of representative, real-world values.

ArmMeasureValue (NUMBER)
Corrie Digital Health Platform GroupCost-effectiveness as Assessed by a Markov Model of Cost-effectiveness17,195 US dollars
Historical Comparison GroupCost-effectiveness as Assessed by a Markov Model of Cost-effectiveness27,940 US dollars
Secondary

In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Continuous Item)

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.

Time frame: 3 days post hospital discharge

Population: 68 participants completed this item on the survey.

ArmMeasureValue (MEDIAN)
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Continuous Item)10 score on a scale
Secondary

In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Dichotomous Item)

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).

Time frame: 3 days post hospital discharge

Population: 88 participants completed this item on the survey.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Dichotomous Item)Yes79 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Dichotomous Item)No9 Participants
Secondary

In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)

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.

Time frame: 3 days post hospital discharge

Population: 89 participants completed all the items on the survey, except for one where one person did not fill out the item/question, resulting in 88 being analyzed for that item.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses treated me with courtesy and respect.Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses treated me with courtesy and respect.Neither Disagree nor Agree1 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)I would recommend this hospital to my friends and family.Strongly Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)I would recommend this hospital to my friends and family.Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)I would recommend this hospital to my friends and family.Neither Disagree nor Agree3 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)I would recommend this hospital to my friends and family.Agree21 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)I would recommend this hospital to my friends and family.Strongly Agree65 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses treated me with courtesy and respect.Strongly Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses treated me with courtesy and respect.Agree15 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses treated me with courtesy and respect.Strongly Agree72 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses listened carefully to me.Strongly Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses listened carefully to me.Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses listened carefully to me.Neither Disagree nor Agree2 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses listened carefully to me.Agree21 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses listened carefully to me.Strongly Agree66 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses explained things in a way I could understand.Strongly Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses explained things in a way I could understand.Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses explained things in a way I could understand.Neither Disagree nor Agree1 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses explained things in a way I could understand.Agree19 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the nurses explained things in a way I could understand.Strongly Agree69 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors treated me with courtesy and respect.Strongly Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors treated me with courtesy and respect.Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors treated me with courtesy and respect.Neither Disagree nor Agree1 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors treated me with courtesy and respect.Agree17 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors treated me with courtesy and respect.Strongly Agree71 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors listened carefully to me.Strongly Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors listened carefully to me.Disagree1 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors listened carefully to me.Neither Disagree nor Agree2 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors listened carefully to me.Agree20 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors listened carefully to me.Strongly Agree66 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors explained things in a way I could understand.Strongly Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors explained things in a way I could understand.Disagree1 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors explained things in a way I could understand.Neither Disagree nor Agree2 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors explained things in a way I could understand.Agree21 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)During this hospital stay, the doctors explained things in a way I could understand.Strongly Agree65 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)The hospital staff talked with me about whether I would have the help I needed after leaving.Strongly Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)The hospital staff talked with me about whether I would have the help I needed after leaving.Disagree1 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)The hospital staff talked with me about whether I would have the help I needed after leaving.Neither Disagree nor Agree3 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)The hospital staff talked with me about whether I would have the help I needed after leaving.Agree33 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)The hospital staff talked with me about whether I would have the help I needed after leaving.Strongly Agree52 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)Before giving any new medications, hospital staff described clearly potential side effects.Strongly Disagree0 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)Before giving any new medications, hospital staff described clearly potential side effects.Disagree9 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)Before giving any new medications, hospital staff described clearly potential side effects.Neither Disagree nor Agree14 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)Before giving any new medications, hospital staff described clearly potential side effects.Agree28 Participants
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)Before giving any new medications, hospital staff described clearly potential side effects.Strongly Agree38 Participants
Secondary

In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (Summary Score)

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.

Time frame: 3 days post hospital discharge

Population: 89 participants completed the items on the survey.

ArmMeasureValue (MEDIAN)
Corrie Digital Health Platform GroupIn-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (Summary Score)43 score on a scale
Secondary

Medication Adherence as Assessed by Smartwatch App Usage Data

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

Time frame: Throughout the study period for app usage up to 30 days post-discharge from the hospital

Population: Unable to differentiate smartwatch app usage data from smartphone app usage data. Thus, results assessing medication adherence by smartwatch app is provided under as assessed by smartphone app usage data (Outcome 13).

Secondary

Number of Deaths Within 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.

Time frame: 30 days post hospital discharge

Population: Unable to obtain data from hospital administrative data sets. Data was not collected.

Secondary

Number of Hospital Observations

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.

Time frame: 30 days post hospital discharge

Population: Unable to obtain this data from hospital administrative data sets. Data was not collected.

Secondary

Number of Participants Who Had Emergency Department Visits Within 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.

Time frame: 30 days post hospital discharge

Population: 908 patients were enrolled at Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center across both the Corrie intervention group (n=174) and historical comparison group (n=734). 80 of the patients had an emergency department visit within 30-days of discharge that resulted in a readmission and were excluded from this analysis. Hence, a total of 828 participants were included in the analysis across the Corrie intervention group (n=164) and the historical comparison group (n=664).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Corrie Digital Health Platform GroupNumber of Participants Who Had Emergency Department Visits Within 30-days Post Hospital Discharge13 Participants
Historical Comparison GroupNumber of Participants Who Had Emergency Department Visits Within 30-days Post Hospital Discharge39 Participants
p-value: 0.3395% CI: [0.69, 2.98]Regression, Cox
Secondary

Number of Readmitted Participants Who Had Recurrent Myocardial Infarctions

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.

Time frame: 30 days post hospital discharge

Population: Total of 13 participants in the Corrie group who were readmitted within 30 days of discharge. Unable to obtain reason for readmission from the hospital administrative data sets. Thus, data on whether 30-day readmissions were due to recurrent myocardial infarction were not available for the historical comparison group. Chart review, to obtain this reason for readmission as done with the Corrie group, was not possible for the historical comparison group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Corrie Digital Health Platform GroupNumber of Readmitted Participants Who Had Recurrent Myocardial Infarctions0 Participants
Secondary

Patient Activation as Assessed by the Patient Activation Measure

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.

Time frame: 3 and 30 days post hospital discharge

Population: At 3-days post discharge only 94 participants completed the survey while at 30 days post-discharge 103 participants completed the survey.

ArmMeasureGroupValue (MEAN)Dispersion
Corrie Digital Health Platform GroupPatient Activation as Assessed by the Patient Activation Measure3 days post-discharge71.9 score on a scaleStandard Deviation 15.7
Corrie Digital Health Platform GroupPatient Activation as Assessed by the Patient Activation Measure30 days post-discharge71.7 score on a scaleStandard Deviation 16.6
Secondary

Perceived Corrie App Satisfaction as Assessed by a Study Team Developed Scale

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.

Time frame: 3 and 30 days post hospital discharge

Population: 80 participants completed the survey at 3 days post-discharge and 99 completed the survey at 30 days post-discharge.

ArmMeasureGroupValue (MEAN)Dispersion
Corrie Digital Health Platform GroupPerceived Corrie App Satisfaction as Assessed by a Study Team Developed Scale3 days post-discharge18.29 score on a scaleStandard Deviation 3.75
Corrie Digital Health Platform GroupPerceived Corrie App Satisfaction as Assessed by a Study Team Developed Scale30 days post-discharge17.65 score on a scaleStandard Deviation 3.68
Secondary

Perceived Usability of Corrie as Assessed by the Systems Usability Scale

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.

Time frame: 3 and 30 days post hospital discharge

Population: At 3 days post discharge, 87 participants completed the survey, while at 30 days post-discharge 104 participants completed the survey.

ArmMeasureGroupValue (MEAN)Dispersion
Corrie Digital Health Platform GroupPerceived Usability of Corrie as Assessed by the Systems Usability Scale3 days post-discharge58.6 score on a scaleStandard Deviation 11.5
Corrie Digital Health Platform GroupPerceived Usability of Corrie as Assessed by the Systems Usability Scale30 days post-discharge57.6 score on a scaleStandard Deviation 11.6
Secondary

User Engagement With Corrie App as Assessed by the User Engagement Scale

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.

Time frame: 30 days post hospital discharge

Population: 102 participants completed the survey at 30 days post-discharge

ArmMeasureValue (MEAN)Dispersion
Corrie Digital Health Platform GroupUser Engagement With Corrie App as Assessed by the User Engagement Scale3.36 score on a scaleStandard Deviation 0.57
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

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.

Time frame: Throughout the study period for app usage up to 30 days post-discharge from the hospital

Population: Following deployment of Corrie backend capabilities (the Corrie backend was not set up to capture application interactions for the first 34 participants enrolled), 83% (138/166) of Corrie users had captured application interactions (i.e. used the Corrie platform at least once over the 30-day study and subsequently connected to WiFi or cellular data to connect with the backend).

ArmMeasureValue (MEDIAN)
Corrie Digital Health Platform GroupUser Engagement With Corrie Health App as Assessed by the Overall Amount of Time Spent Using the App, Collected Via Corrie Health Platform App User Analytics12 days
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

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.

Time frame: Throughout the study period for app usage up to 30 days post-discharge from the hospital

Population: Following deployment of Corrie backend capabilities (the Corrie backend was not set up to capture application interactions for the first 34 participants enrolled), 83% (138/166) of Corrie users had captured application interactions (i.e. used the Corrie platform at least once over the 30-day study and subsequently connected to WiFi or cellular data to connect with the backend).

ArmMeasureValue (MEDIAN)
Corrie Digital Health Platform GroupUser 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 Analytics213 Number of app interactions/participant

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026