Trial Outcomes & Findings for Myocardial Infarction, COmbined-device, Recovery Enhancement Study (NCT NCT03760796)
NCT ID: NCT03760796
Last Updated: 2021-07-29
Results Overview
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.
COMPLETED
NA
200 participants
30-days post hospital discharge
2021-07-29
Participant Flow
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.
Patients in the historical comparison group were not considered enrolled in this study.
Participant milestones
| Measure |
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
864
|
|
Overall Study
COMPLETED
|
200
|
864
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
Baseline characteristics by cohort
| Measure |
Corrie Digital Health Platform Group
n=200 Participants
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.
|
Historical Comparison Group
n=864 Participants
Receives the standard of care
|
Total
n=1064 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Intervention (during index admission)
Percutaneous coronary intervention alone
|
131 Participants
n=200 Participants
|
320 Participants
n=864 Participants
|
451 Participants
n=1064 Participants
|
|
Intervention (during index admission)
Neither
|
17 Participants
n=200 Participants
|
406 Participants
n=864 Participants
|
423 Participants
n=1064 Participants
|
|
Intervention (during index admission)
Coronary artery bypass grafting surgery alone
|
44 Participants
n=200 Participants
|
134 Participants
n=864 Participants
|
178 Participants
n=1064 Participants
|
|
Length of stay
|
5 days
n=200 Participants
|
4 days
n=864 Participants
|
4 days
n=1064 Participants
|
|
Intervention (during index admission)
Both
|
8 Participants
n=200 Participants
|
4 Participants
n=864 Participants
|
12 Participants
n=1064 Participants
|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 11.5 • n=200 Participants
|
65.4 years
STANDARD_DEVIATION 14.1 • n=864 Participants
|
64.3 years
STANDARD_DEVIATION 13.9 • n=1064 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=200 Participants
|
336 Participants
n=864 Participants
|
394 Participants
n=1064 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=200 Participants
|
528 Participants
n=864 Participants
|
670 Participants
n=1064 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
137 Participants
n=200 Participants
|
561 Participants
n=864 Participants
|
698 Participants
n=1064 Participants
|
|
Race/Ethnicity, Customized
Race · Non-White
|
57 Participants
n=200 Participants
|
285 Participants
n=864 Participants
|
342 Participants
n=1064 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
6 Participants
n=200 Participants
|
18 Participants
n=864 Participants
|
24 Participants
n=1064 Participants
|
|
Insurance status
Private insurance/PPO/HMO
|
110 Participants
n=200 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
348 Participants
n=864 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
458 Participants
n=1064 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
|
Insurance status
Medicare
|
62 Participants
n=200 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
428 Participants
n=864 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
490 Participants
n=1064 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
|
Insurance status
Medicaid
|
22 Participants
n=200 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
45 Participants
n=864 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
67 Participants
n=1064 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
|
Insurance status
Self-pay
|
6 Participants
n=200 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
11 Participants
n=864 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
17 Participants
n=1064 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
|
Insurance status
Unknown
|
0 Participants
n=200 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
32 Participants
n=864 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
32 Participants
n=1064 Participants • In historical comparison group a primary payer for insurance of "Workers compensation/unknown" considered as "unknown".
|
|
Marital status
Married
|
117 Participants
n=200 Participants
|
359 Participants
n=864 Participants
|
476 Participants
n=1064 Participants
|
|
Marital status
Not married
|
77 Participants
n=200 Participants
|
465 Participants
n=864 Participants
|
542 Participants
n=1064 Participants
|
|
Marital status
Unknown
|
6 Participants
n=200 Participants
|
40 Participants
n=864 Participants
|
46 Participants
n=1064 Participants
|
|
Body mass index
|
30.6 kg/m^2
STANDARD_DEVIATION 5.9 • n=200 Participants • 26.6% missing body mass index data for historical control group
|
29.5 kg/m^2
STANDARD_DEVIATION 8.2 • n=634 Participants • 26.6% missing body mass index data for historical control group
|
29.7 kg/m^2
STANDARD_DEVIATION 7.9 • n=834 Participants • 26.6% missing body mass index data for historical control group
|
|
Smoking status
Current smoker
|
57 Participants
n=200 Participants • 13.2% (114/864) of the participants in the historical comparison group had missing data for smoking status.
|
193 Participants
n=750 Participants • 13.2% (114/864) of the participants in the historical comparison group had missing data for smoking status.
|
250 Participants
n=950 Participants • 13.2% (114/864) of the participants in the historical comparison group had missing data for smoking status.
|
|
Smoking status
Former smoker
|
53 Participants
n=200 Participants • 13.2% (114/864) of the participants in the historical comparison group had missing data for smoking status.
|
284 Participants
n=750 Participants • 13.2% (114/864) of the participants in the historical comparison group had missing data for smoking status.
|
337 Participants
n=950 Participants • 13.2% (114/864) of the participants in the historical comparison group had missing data for smoking status.
|
|
Smoking status
Never smoker
|
90 Participants
n=200 Participants • 13.2% (114/864) of the participants in the historical comparison group had missing data for smoking status.
|
273 Participants
n=750 Participants • 13.2% (114/864) of the participants in the historical comparison group had missing data for smoking status.
|
363 Participants
n=950 Participants • 13.2% (114/864) of the participants in the historical comparison group had missing data for smoking status.
|
|
Total Elixhauser comorbidity count
|
3 Number of comorbidities per patient
n=195 Participants • Unweighted, Agency for Healthcare Research and Quality Elixhauser comorbidity count includes 29 comorbidities with no imputation for missing values. 2.5% missing data for the Corrie intervention group and 1.9% missing data for the historical comparison group.
|
4 Number of comorbidities per patient
n=848 Participants • Unweighted, Agency for Healthcare Research and Quality Elixhauser comorbidity count includes 29 comorbidities with no imputation for missing values. 2.5% missing data for the Corrie intervention group and 1.9% missing data for the historical comparison group.
|
4 Number of comorbidities per patient
n=1043 Participants • Unweighted, Agency for Healthcare Research and Quality Elixhauser comorbidity count includes 29 comorbidities with no imputation for missing values. 2.5% missing data for the Corrie intervention group and 1.9% missing data for the historical comparison group.
|
|
Hospital of Admission
Johns Hopkins Hospital
|
104 Participants
n=200 Participants
|
437 Participants
n=864 Participants
|
541 Participants
n=1064 Participants
|
|
Hospital of Admission
Johns Hopkins Bayview Medical Center
|
70 Participants
n=200 Participants
|
297 Participants
n=864 Participants
|
367 Participants
n=1064 Participants
|
|
Hospital of Admission
Massachusetts General Hospital
|
14 Participants
n=200 Participants
|
70 Participants
n=864 Participants
|
84 Participants
n=1064 Participants
|
|
Hospital of Admission
Reading Hospital
|
12 Participants
n=200 Participants
|
60 Participants
n=864 Participants
|
72 Participants
n=1064 Participants
|
|
Type of Acute Myocardial Infarction
NSTEMI
|
121 Participants
n=200 Participants
|
676 Participants
n=864 Participants
|
797 Participants
n=1064 Participants
|
|
Type of Acute Myocardial Infarction
STEMI
|
79 Participants
n=200 Participants
|
188 Participants
n=864 Participants
|
267 Participants
n=1064 Participants
|
|
Discharge disposition
Home
|
167 Participants
n=200 Participants
|
555 Participants
n=864 Participants
|
722 Participants
n=1064 Participants
|
|
Discharge disposition
Home care
|
18 Participants
n=200 Participants
|
182 Participants
n=864 Participants
|
200 Participants
n=1064 Participants
|
|
Discharge disposition
Skilled nursing facility
|
1 Participants
n=200 Participants
|
44 Participants
n=864 Participants
|
45 Participants
n=1064 Participants
|
|
Discharge disposition
Rehabilitation
|
12 Participants
n=200 Participants
|
22 Participants
n=864 Participants
|
34 Participants
n=1064 Participants
|
|
Discharge disposition
Hospice/other hospital
|
2 Participants
n=200 Participants
|
46 Participants
n=864 Participants
|
48 Participants
n=1064 Participants
|
|
Discharge disposition
AMA/shelters/police custody/unknown
|
0 Participants
n=200 Participants
|
15 Participants
n=864 Participants
|
15 Participants
n=1064 Participants
|
|
Duration of education
|
14.6 years
STANDARD_DEVIATION 3.6 • n=138 Participants • 31% missing data for formal education in the Corrie group. This data is not available in the electronic medical record so it could not be obtained for the historical comparison group.
|
—
|
14.6 years
STANDARD_DEVIATION 3.6 • n=138 Participants • 31% missing data for formal education in the Corrie group. This data is not available in the electronic medical record so it could not be obtained for the historical comparison group.
|
|
Household income per year
|
70,000 US dollars
n=91 Participants • 54.5% missing data on household income for the Corrie intervention group. This data is not available in the electronic medical record so it could not be obtained for the historical comparison group.
|
—
|
70,000 US dollars
n=91 Participants • 54.5% missing data on household income for the Corrie intervention group. This data is not available in the electronic medical record so it could not be obtained for the historical comparison group.
|
PRIMARY outcome
Timeframe: 30-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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=200 Participants
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.
|
Historical Comparison Group
n=864 Participants
Receives the standard of care
|
|---|---|---|
|
Number of Participants Readmitted Within 30-days Post Hospital Discharge
|
13 Participants
|
145 Participants
|
SECONDARY outcome
Timeframe: 30 days post hospital dischargePopulation: 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.
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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=200 Participants
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.
|
Historical Comparison Group
n=864 Participants
Receives the standard of care
|
|---|---|---|
|
Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness
|
17,195 US dollars
|
27,940 US dollars
|
SECONDARY outcome
Timeframe: 3 days post hospital dischargePopulation: 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.
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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=89 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: 3 days post hospital dischargePopulation: 89 participants completed the items on the survey.
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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=89 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
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
Interval 40.0 to 45.0
|
—
|
SECONDARY outcome
Timeframe: 3 days post hospital dischargePopulation: 88 participants completed this item on the survey.
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).
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=88 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: 3 days post hospital dischargePopulation: 68 participants completed this item on the survey.
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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=68 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
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
Interval 9.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: 3 and 30 days post hospital dischargePopulation: At 3 days post discharge, 87 participants completed the survey, while at 30 days post-discharge 104 participants completed the survey.
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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=104 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: 3 and 30 days post hospital dischargePopulation: 80 participants completed the survey at 3 days post-discharge and 99 completed the survey at 30 days post-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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=99 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: 30 days post hospital dischargePopulation: 102 participants completed the survey at 30 days post-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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=102 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
User Engagement With Corrie App as Assessed by the User Engagement Scale
|
3.36 score on a scale
Standard Deviation 0.57
|
—
|
SECONDARY outcome
Timeframe: Throughout the study period for app usage up to 30 days post-discharge from the hospitalPopulation: 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).
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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=138 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
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
Interval 35.0 to 428.0
|
—
|
SECONDARY outcome
Timeframe: Throughout the study period for app usage up to 30 days post-discharge from the hospitalPopulation: 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).
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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=138 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
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
Interval 2.0 to 29.0
|
—
|
SECONDARY outcome
Timeframe: 3 and 30 days post hospital dischargePopulation: At 3-days post discharge only 94 participants completed the survey while at 30 days post-discharge 103 participants completed the survey.
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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=103 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
Patient Activation as Assessed by the Patient Activation Measure
3 days post-discharge
|
71.9 score on a scale
Standard Deviation 15.7
|
—
|
|
Patient Activation as Assessed by the Patient Activation Measure
30 days post-discharge
|
71.7 score on a scale
Standard Deviation 16.6
|
—
|
SECONDARY outcome
Timeframe: 30 days post hospital dischargePopulation: 102 participants completed the survey at 30 days post-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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=102 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale
Complete Adherence
|
81 Participants
|
—
|
|
Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale
Near Complete Adherence
|
21 Participants
|
—
|
SECONDARY outcome
Timeframe: Throughout the study period for app usage up to 30 days post-discharge from the hospitalPopulation: 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.
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".
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=135 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
Cardiac Medication Adherence as Assessed by Smartphone App Usage Data
|
87 percentage of any CVD meds marked taken
Interval 82.0 to 92.0
|
—
|
SECONDARY outcome
Timeframe: Throughout the study period for app usage up to 30 days post-discharge from the hospitalPopulation: 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).
Medication adherence is measured from the smartwatch app usage data as percent of pills marked as taken.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days post hospital dischargePopulation: 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).
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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=164 Participants
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.
|
Historical Comparison Group
n=664 Participants
Receives the standard of care
|
|---|---|---|
|
Number of Participants Who Had Emergency Department Visits Within 30-days Post Hospital Discharge
|
13 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 30 days post hospital dischargePopulation: Unable to obtain this data from hospital administrative data sets. Data was not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days post hospital dischargePopulation: 104 participants completed this survey question at 30 days post-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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=104 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team
3 appointments attended
|
34 Participants
|
—
|
|
Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team
2 appointments attended
|
48 Participants
|
—
|
|
Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team
1 appointment attended
|
19 Participants
|
—
|
|
Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team
0 appointments attended
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post hospital dischargePopulation: 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.
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.
Outcome measures
| Measure |
Corrie Digital Health Platform Group
n=13 Participants
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.
|
Historical Comparison Group
Receives the standard of care
|
|---|---|---|
|
Number of Readmitted Participants Who Had Recurrent Myocardial Infarctions
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days post hospital dischargePopulation: Unable to obtain data from hospital administrative data sets. Data was not collected.
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.
Outcome measures
Outcome data not reported
Adverse Events
Corrie Digital Health Platform Group
Serious adverse events
| Measure |
Corrie Digital Health Platform Group
n=200 participants at risk
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.
The sample size for reporting of adverse events is 216. 200 Corrie patients that finished the study plus 16 who were consented but later withdrew or were withdrawn from the study.
|
|---|---|
|
General disorders
Inpatient hospital readmission within 30 days post-discharge
|
6.5%
13/200 • Adverse event data were collected from the time of enrollment in the hospital to 30 days post-discharge, for the Corrie Digital Health Platform group.
While 30-day hospital readmission data was collected for both the Corrie Digital Health Platform and Historical Comparison groups this data is not listed here for the Historical Comparison group because they were not enrolled participants. All-cause mortality data could not be obtained from hospital administrative databases. It was reported to the study team by the participant's family member. This explains why outcome measure 20 has no data but 1 mortality reported here.
|
Other adverse events
| Measure |
Corrie Digital Health Platform Group
n=200 participants at risk
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.
The sample size for reporting of adverse events is 216. 200 Corrie patients that finished the study plus 16 who were consented but later withdrew or were withdrawn from the study.
|
|---|---|
|
General disorders
Bruising
|
0.50%
1/200 • Adverse event data were collected from the time of enrollment in the hospital to 30 days post-discharge, for the Corrie Digital Health Platform group.
While 30-day hospital readmission data was collected for both the Corrie Digital Health Platform and Historical Comparison groups this data is not listed here for the Historical Comparison group because they were not enrolled participants. All-cause mortality data could not be obtained from hospital administrative databases. It was reported to the study team by the participant's family member. This explains why outcome measure 20 has no data but 1 mortality reported here.
|
Additional Information
Dr. Seth Martin
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place