Acute Coronary Syndrome, Acute Myocardial Infarction, Coronary Artery Disease, Myocardial Infarction
Conditions
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
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Readmitted Within 30-days Post Hospital Discharge | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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). |
| 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 | 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. |
| Perceived Usability of Corrie as Assessed by the Systems Usability Scale | 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 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 Scale | 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 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 Scale | 30 days post hospital discharge | 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. |
| 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 | 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. |
| 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 | 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. |
| Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness | 30 days post hospital discharge | 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. |
| Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale | 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 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 Data | Throughout the study period for app usage up to 30 days post-discharge from the hospital | 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. |
| 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 | Medication 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 Discharge | 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. |
| Number of Hospital Observations | 30 days post hospital discharge | 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. |
| Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team | 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. |
| Number of Readmitted Participants Who Had Recurrent Myocardial Infarctions | 30 days post hospital discharge | 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. |
| Number of Deaths Within 30 Days Post Hospital Discharge | 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. |
| Patient Activation as Assessed by the Patient Activation Measure | 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 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
| Arm | Count |
|---|---|
| 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 |
| Total | 1,064 |
Baseline characteristics
| Characteristic | Corrie Digital Health Platform Group | Historical Comparison Group | Total |
|---|---|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 11.5 | 65.4 years STANDARD_DEVIATION 14.1 | 64.3 years STANDARD_DEVIATION 13.9 |
| Body mass index | 30.6 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 Participants | 15 Participants | 15 Participants |
| Discharge disposition Home | 167 Participants | 555 Participants | 722 Participants |
| Discharge disposition Home care | 18 Participants | 182 Participants | 200 Participants |
| Discharge disposition Hospice/other hospital | 2 Participants | 46 Participants | 48 Participants |
| Discharge disposition Rehabilitation | 12 Participants | 22 Participants | 34 Participants |
| Discharge disposition Skilled nursing facility | 1 Participants | 44 Participants | 45 Participants |
| Duration of education | 14.6 years STANDARD_DEVIATION 3.6 | — | 14.6 years STANDARD_DEVIATION 3.6 |
| Hospital of Admission Johns Hopkins Bayview Medical Center | 70 Participants | 297 Participants | 367 Participants |
| Hospital of Admission Johns Hopkins Hospital | 104 Participants | 437 Participants | 541 Participants |
| Hospital of Admission Massachusetts General Hospital | 14 Participants | 70 Participants | 84 Participants |
| Hospital of Admission Reading Hospital | 12 Participants | 60 Participants | 72 Participants |
| Household income per year | 70,000 US dollars | — | 70,000 US dollars |
| Insurance status Medicaid | 22 Participants | 45 Participants | 67 Participants |
| Insurance status Medicare | 62 Participants | 428 Participants | 490 Participants |
| Insurance status Private insurance/PPO/HMO | 110 Participants | 348 Participants | 458 Participants |
| Insurance status Self-pay | 6 Participants | 11 Participants | 17 Participants |
| Insurance status Unknown | 0 Participants | 32 Participants | 32 Participants |
| Intervention (during index admission) Both | 8 Participants | 4 Participants | 12 Participants |
| Intervention (during index admission) Coronary artery bypass grafting surgery alone | 44 Participants | 134 Participants | 178 Participants |
| Intervention (during index admission) Neither | 17 Participants | 406 Participants | 423 Participants |
| Intervention (during index admission) Percutaneous coronary intervention alone | 131 Participants | 320 Participants | 451 Participants |
| Length of stay | 5 days | 4 days | 4 days |
| Marital status Married | 117 Participants | 359 Participants | 476 Participants |
| Marital status Not married | 77 Participants | 465 Participants | 542 Participants |
| Marital status Unknown | 6 Participants | 40 Participants | 46 Participants |
| Race/Ethnicity, Customized Race Non-White | 57 Participants | 285 Participants | 342 Participants |
| Race/Ethnicity, Customized Race Unknown | 6 Participants | 18 Participants | 24 Participants |
| Race/Ethnicity, Customized Race White | 137 Participants | 561 Participants | 698 Participants |
| Sex: Female, Male Female | 58 Participants | 336 Participants | 394 Participants |
| Sex: Female, Male Male | 142 Participants | 528 Participants | 670 Participants |
| Smoking status Current smoker | 57 Participants | 193 Participants | 250 Participants |
| Smoking status Former smoker | 53 Participants | 284 Participants | 337 Participants |
| Smoking status Never smoker | 90 Participants | 273 Participants | 363 Participants |
| Total Elixhauser comorbidity count | 3 Number of comorbidities per patient | 4 Number of comorbidities per patient | 4 Number of comorbidities per patient |
| Type of Acute Myocardial Infarction NSTEMI | 121 Participants | 676 Participants | 797 Participants |
| Type of Acute Myocardial Infarction STEMI | 79 Participants | 188 Participants | 267 Participants |
Adverse events
| Event type | EG000 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
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Corrie Digital Health Platform Group | Number of Participants Readmitted Within 30-days Post Hospital Discharge | 13 Participants |
| Historical Comparison Group | Number of Participants Readmitted Within 30-days Post Hospital Discharge | 145 Participants |
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corrie Digital Health Platform Group | Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team | 3 appointments attended | 34 Participants |
| Corrie Digital Health Platform Group | Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team | 2 appointments attended | 48 Participants |
| Corrie Digital Health Platform Group | Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team | 1 appointment attended | 19 Participants |
| Corrie Digital Health Platform Group | Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team | 0 appointments attended | 3 Participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corrie Digital Health Platform Group | Cardiac Medication Adherence as Assessed by Smartphone App Usage Data | 87 percentage of any CVD meds marked taken |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corrie Digital Health Platform Group | Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale | Complete Adherence | 81 Participants |
| Corrie Digital Health Platform Group | Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale | Near Complete Adherence | 21 Participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corrie Digital Health Platform Group | Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness | 17,195 US dollars |
| Historical Comparison Group | Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness | 27,940 US dollars |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Corrie Digital Health Platform Group | In-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 |
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corrie Digital Health Platform Group | In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Dichotomous Item) | Yes | 79 Participants |
| Corrie Digital Health Platform Group | In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Dichotomous Item) | No | 9 Participants |
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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Corrie Digital Health Platform Group | In-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. | Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 1 Participants |
| Corrie Digital Health Platform Group | In-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 Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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. | Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 3 Participants |
| Corrie Digital Health Platform Group | In-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. | Agree | 21 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 65 Participants |
| Corrie Digital Health Platform Group | In-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 Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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. | Agree | 15 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 72 Participants |
| Corrie Digital Health Platform Group | In-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 Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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. | Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 2 Participants |
| Corrie Digital Health Platform Group | In-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. | Agree | 21 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 66 Participants |
| Corrie Digital Health Platform Group | In-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 Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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. | Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 1 Participants |
| Corrie Digital Health Platform Group | In-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. | Agree | 19 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 69 Participants |
| Corrie Digital Health Platform Group | In-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 Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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. | Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 1 Participants |
| Corrie Digital Health Platform Group | In-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. | Agree | 17 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 71 Participants |
| Corrie Digital Health Platform Group | In-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 Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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. | Disagree | 1 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 2 Participants |
| Corrie Digital Health Platform Group | In-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. | Agree | 20 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 66 Participants |
| Corrie Digital Health Platform Group | In-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 Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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. | Disagree | 1 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 2 Participants |
| Corrie Digital Health Platform Group | In-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. | Agree | 21 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 65 Participants |
| Corrie Digital Health Platform Group | In-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 Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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. | Disagree | 1 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 3 Participants |
| Corrie Digital Health Platform Group | In-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. | Agree | 33 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 52 Participants |
| Corrie Digital Health Platform Group | In-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 Disagree | 0 Participants |
| Corrie Digital Health Platform Group | In-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. | Disagree | 9 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 14 Participants |
| Corrie Digital Health Platform Group | In-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. | Agree | 28 Participants |
| Corrie Digital Health Platform Group | In-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 Agree | 38 Participants |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Corrie Digital Health Platform Group | In-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 |
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).
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.
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.
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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Corrie Digital Health Platform Group | Number of Participants Who Had Emergency Department Visits Within 30-days Post Hospital Discharge | 13 Participants |
| Historical Comparison Group | Number of Participants Who Had Emergency Department Visits Within 30-days Post Hospital Discharge | 39 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Corrie Digital Health Platform Group | Number of Readmitted Participants Who Had Recurrent Myocardial Infarctions | 0 Participants |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corrie Digital Health Platform Group | Patient Activation as Assessed by the Patient Activation Measure | 3 days post-discharge | 71.9 score on a scale | Standard Deviation 15.7 |
| Corrie Digital Health Platform Group | Patient Activation as Assessed by the Patient Activation Measure | 30 days post-discharge | 71.7 score on a scale | Standard Deviation 16.6 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corrie Digital Health Platform Group | Perceived Corrie App Satisfaction as Assessed by a Study Team Developed Scale | 3 days post-discharge | 18.29 score on a scale | Standard Deviation 3.75 |
| Corrie Digital Health Platform Group | Perceived Corrie App Satisfaction as Assessed by a Study Team Developed Scale | 30 days post-discharge | 17.65 score on a scale | Standard Deviation 3.68 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corrie Digital Health Platform Group | Perceived Usability of Corrie as Assessed by the Systems Usability Scale | 3 days post-discharge | 58.6 score on a scale | Standard Deviation 11.5 |
| Corrie Digital Health Platform Group | Perceived Usability of Corrie as Assessed by the Systems Usability Scale | 30 days post-discharge | 57.6 score on a scale | Standard Deviation 11.6 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Digital Health Platform Group | User Engagement With Corrie App as Assessed by the User Engagement Scale | 3.36 score on a scale | Standard Deviation 0.57 |
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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Corrie Digital Health Platform Group | 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 days |
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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Corrie Digital Health Platform Group | 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 Number of app interactions/participant |