MiCORE: Myocardial Infarction, COmbined-device, Recovery Enhancement Study
Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT03760796
Collaborator
Apple Inc. (Industry), iHealth (Other)
200
4
1
38.5
50
1.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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)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)
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Johns Hopkins Myocardial Infarction, COmbined-device, Recovery Enhancement (MiCORE) Study
Actual Study Start Date
:
Oct 1, 2016
Actual Primary Completion Date
:
Dec 17, 2019
Actual Study Completion Date
:
Dec 17, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Corrie Health Digital Platform group Receives the Corrie Health intervention plus the standard of care |
Device: Corrie Health Digital Platform
The Corrie Health Digital Platform consists of the Corrie smartphone app for heart attack recovery which is paired with an Apple Watch and Bluetooth-enabled, iHealth blood pressure monitor.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Corrie Health Digital Platform group
Inclusion Criteria:
-
Admitted for acute myocardial infarction (STEMI or Type 1 NSTEMI)
-
18 years or older
-
English-speaking
-
Own any type of smartphone
Exclusion Criteria:
-
Visual, hearing, or motor impairment which precludes the use of the intervention
-
Inability to participate due to severity of illness (e.g., intubated and on sedation in the setting of cardiogenic shock). If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member returns at a later date to determine whether this status has changed.
Historical Standard of Care Comparison group
Inclusion Criteria:
-
Admitted for acute myocardial infarction (STEMI or NSTEMI)
-
18 years or older
-
English-speaking
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins Bayview Medical Center | Baltimore | Maryland | United States | 21224 |
| 2 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21287 |
| 3 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 4 | Reading Hospital-Tower Health | Reading | Pennsylvania | United States | 19611 |
Sponsors and Collaborators
- Johns Hopkins University
- Apple Inc.
- iHealth
Investigators
- Principal Investigator: Seth S Martin, MD, MHS, Johns Hopkins University
Study Documents (Full-Text)
More Information
Additional Information:
- Corrie Health Digital Platform for Self-Management in Secondary Prevention After Acute Myocardial Infarction
- Technical Guidance for Clinicians Interested in Partnering With Engineers in Mobile Health Development and Evaluation
- Digital Health Innovation: A Toolkit to Navigate From Concept to Clinical Testing
- Sociodemographic Characteristics Predicting Digital Health Intervention Use After Acute Myocardial Infarction
- Early blood pressure assessment after acute myocardial infarction: Insights using digital health technology
- Strategies for the Successful Implementation of a Novel iPhone Loaner System (iShare) in mHealth Interventions: Prospective Study
- Mobile health application platform 'Corrie' personalises and empowers the heart attack recovery patient experience in the hospital and at home for an underserved heart attack survivor
Publications
- Marvel FA, Wang J, Martin SS. Digital Health Innovation: A Toolkit to Navigate From Concept to Clinical Testing. JMIR Cardio. 2018 Jan 18;2(1):e2. doi: 10.2196/cardio.7586.
- Shah LM, Yang WE, Demo RC, Lee MA, Weng D, Shan R, Wongvibulsin S, Spaulding EM, Marvel FA, Martin SS. Technical Guidance for Clinicians Interested in Partnering With Engineers in Mobile Health Development and Evaluation. JMIR Mhealth Uhealth. 2019 May 15;7(5):e14124. doi: 10.2196/14124.
- Spaulding EM, Marvel FA, Lee MA, Yang WE, Demo R, Wang J, Xun H, Shah L, Weng D, Fashanu OE, Carter J, Sheidy J, McLin R, Flowers J, Majmudar M, Elgin E, Vilarino V, Lumelsky D, Bhardwaj V, Padula W, Allen JK, Martin SS. Corrie Health Digital Platform for Self-Management in Secondary Prevention After Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005509. doi: 10.1161/CIRCOUTCOMES.119.005509.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT03760796
Other Study ID Numbers:
- IRB00099938
First Posted:
Nov 30, 2018
Last Update Posted:
Jul 29, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms:
Study Results
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 Detail | Patients in the historical comparison group were not considered enrolled in this study. |
| Arm/Group Title | Corrie Digital Health Platform Group | Historical Comparison Group |
|---|---|---|
| Arm/Group Description | 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. | Receives the standard of care |
| Period Title: Overall Study | ||
| STARTED | 200 | 864 |
| COMPLETED | 200 | 864 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Corrie Digital Health Platform Group | Historical Comparison Group | Total |
|---|---|---|---|
| Arm/Group Description | 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. | Receives the standard of care | Total of all reporting groups |
| Overall Participants | 200 | 864 | 1064 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
59.2
(11.5)
|
65.4
(14.1)
|
64.3
(13.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
58
29%
|
336
38.9%
|
394
37%
|
| Male |
142
71%
|
528
61.1%
|
670
63%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White |
137
68.5%
|
561
64.9%
|
698
65.6%
|
| Non-White |
57
28.5%
|
285
33%
|
342
32.1%
|
| Unknown |
6
3%
|
18
2.1%
|
24
2.3%
|
| Insurance status (Count of Participants) | |||
| Private insurance/PPO/HMO |
110
55%
|
348
40.3%
|
458
43%
|
| Medicare |
62
31%
|
428
49.5%
|
490
46.1%
|
| Medicaid |
22
11%
|
45
5.2%
|
67
6.3%
|
| Self-pay |
6
3%
|
11
1.3%
|
17
1.6%
|
| Unknown |
0
0%
|
32
3.7%
|
32
3%
|
| Marital status (Count of Participants) | |||
| Married |
117
58.5%
|
359
41.6%
|
476
44.7%
|
| Not married |
77
38.5%
|
465
53.8%
|
542
50.9%
|
| Unknown |
6
3%
|
40
4.6%
|
46
4.3%
|
| Body mass index (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
30.6
(5.9)
|
29.5
(8.2)
|
29.7
(7.9)
|
| Smoking status (Count of Participants) | |||
| Current smoker |
57
28.5%
|
193
22.3%
|
250
23.5%
|
| Former smoker |
53
26.5%
|
284
32.9%
|
337
31.7%
|
| Never smoker |
90
45%
|
273
31.6%
|
363
34.1%
|
| Total Elixhauser comorbidity count (Number of comorbidities per patient) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [Number of comorbidities per patient] |
3
|
4
|
4
|
| Hospital of Admission (Count of Participants) | |||
| Johns Hopkins Hospital |
104
52%
|
437
50.6%
|
541
50.8%
|
| Johns Hopkins Bayview Medical Center |
70
35%
|
297
34.4%
|
367
34.5%
|
| Massachusetts General Hospital |
14
7%
|
70
8.1%
|
84
7.9%
|
| Reading Hospital |
12
6%
|
60
6.9%
|
72
6.8%
|
| Type of Acute Myocardial Infarction (Count of Participants) | |||
| NSTEMI |
121
60.5%
|
676
78.2%
|
797
74.9%
|
| STEMI |
79
39.5%
|
188
21.8%
|
267
25.1%
|
| Intervention (during index admission) (Count of Participants) | |||
| Percutaneous coronary intervention alone |
131
65.5%
|
320
37%
|
451
42.4%
|
| Coronary artery bypass grafting surgery alone |
44
22%
|
134
15.5%
|
178
16.7%
|
| Both |
8
4%
|
4
0.5%
|
12
1.1%
|
| Neither |
17
8.5%
|
406
47%
|
423
39.8%
|
| Length of stay (days) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [days] |
5
|
4
|
4
|
| Discharge disposition (Count of Participants) | |||
| Home |
167
83.5%
|
555
64.2%
|
722
67.9%
|
| Home care |
18
9%
|
182
21.1%
|
200
18.8%
|
| Skilled nursing facility |
1
0.5%
|
44
5.1%
|
45
4.2%
|
| Rehabilitation |
12
6%
|
22
2.5%
|
34
3.2%
|
| Hospice/other hospital |
2
1%
|
46
5.3%
|
48
4.5%
|
| AMA/shelters/police custody/unknown |
0
0%
|
15
1.7%
|
15
1.4%
|
| Duration of education (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
14.6
(3.6)
|
14.6
(3.6)
|
|
| Household income per year (US dollars) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [US dollars] |
70,000
|
70,000
|
|
Outcome Measures
| Title | Number of Participants Readmitted Within 30-days Post Hospital Discharge |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Corrie Digital Health Platform Group | Historical Comparison Group |
|---|---|---|
| Arm/Group Description | 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. | Receives the standard of care |
| Measure Participants | 200 | 864 |
| Count of Participants [Participants] |
13
6.5%
|
145
16.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Corrie Digital Health Platform Group, Historical Comparison Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.018 |
| Comments | The a priori threshold for statistical significance was <0.05. | |
| Method | Regression, Cox | |
| Comments | Adjusting for hospital site and a propensity score inclusive of individual level baseline characteristics. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.48 | |
| Confidence Interval |
(2-Sided) 95% 0.26 to 0.88 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Corrie Digital Health Platform Group | Historical Comparison Group |
|---|---|---|
| Arm/Group Description | 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. obtained from the literature. | Receives the standard of care |
| Measure Participants | 200 | 864 |
| Number [US dollars] |
17,195
|
27,940
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Corrie Digital Health Platform Group, Historical Comparison Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | A Markov Model of cost-effectiveness, based on 30-day readmission rates, was built to assess the Incremental Cost-Effectiveness Ratio (ICER) of adopting the Corrie Platform compared to standard of care for post AMI patients; taking into account the estimated cost of Corrie ($2,750 per patient for a 1-year use term). The reported value is a ratio of the relative cost of intervention compared to the standard of care divided by the change in the outcome, quality-adjusted life years (QALYs). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Incremental Cost-Effectiveness Ratio |
| Estimated Value | -7,319 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | A negative ICER means the intervention cost is lower than the cost of standard of care, while the denominator was positive. A positive ICER means the intervention cost is greater than the cost of standard of care, while the denominator was positive. | |
| Title | In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 89 |
| Strongly Disagree |
0
0%
|
| Disagree |
0
0%
|
| Neither Disagree nor Agree |
3
1.5%
|
| Agree |
21
10.5%
|
| Strongly Agree |
65
32.5%
|
| Strongly Disagree |
0
0%
|
| Disagree |
0
0%
|
| Neither Disagree nor Agree |
1
0.5%
|
| Agree |
15
7.5%
|
| Strongly Agree |
72
36%
|
| Strongly Disagree |
0
0%
|
| Disagree |
0
0%
|
| Neither Disagree nor Agree |
2
1%
|
| Agree |
21
10.5%
|
| Strongly Agree |
66
33%
|
| Strongly Disagree |
0
0%
|
| Disagree |
0
0%
|
| Neither Disagree nor Agree |
1
0.5%
|
| Agree |
19
9.5%
|
| Strongly Agree |
69
34.5%
|
| Strongly Disagree |
0
0%
|
| Disagree |
0
0%
|
| Neither Disagree nor Agree |
1
0.5%
|
| Agree |
17
8.5%
|
| Strongly Agree |
71
35.5%
|
| Strongly Disagree |
0
0%
|
| Disagree |
1
0.5%
|
| Neither Disagree nor Agree |
2
1%
|
| Agree |
20
10%
|
| Strongly Agree |
66
33%
|
| Strongly Disagree |
0
0%
|
| Disagree |
1
0.5%
|
| Neither Disagree nor Agree |
2
1%
|
| Agree |
21
10.5%
|
| Strongly Agree |
65
32.5%
|
| Strongly Disagree |
0
0%
|
| Disagree |
1
0.5%
|
| Neither Disagree nor Agree |
3
1.5%
|
| Agree |
33
16.5%
|
| Strongly Agree |
52
26%
|
| Strongly Disagree |
0
0%
|
| Disagree |
9
4.5%
|
| Neither Disagree nor Agree |
14
7%
|
| Agree |
28
14%
|
| Strongly Agree |
38
19%
|
| Title | In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (Summary Score) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 89 participants completed the items on the survey. |
| Arm/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 89 |
| Median (Inter-Quartile Range) [score on a scale] |
43
|
| Title | In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Dichotomous Item) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 88 participants completed this item on the survey. |
| Arm/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 88 |
| Yes |
79
39.5%
|
| No |
9
4.5%
|
| Title | In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Continuous Item) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 68 participants completed this item on the survey. |
| Arm/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 68 |
| Median (Inter-Quartile Range) [score on a scale] |
10
|
| Title | Perceived Usability of Corrie as Assessed by the Systems Usability Scale |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| At 3 days post discharge, 87 participants completed the survey, while at 30 days post-discharge 104 participants completed the survey. |
| Arm/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 104 |
| 3 days post-discharge |
58.6
(11.5)
|
| 30 days post-discharge |
57.6
(11.6)
|
| Title | Perceived Corrie App Satisfaction as Assessed by a Study Team Developed Scale |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 80 participants completed the survey at 3 days post-discharge and 99 completed the survey at 30 days post-discharge. |
| Arm/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 99 |
| 3 days post-discharge |
18.29
(3.75)
|
| 30 days post-discharge |
17.65
(3.68)
|
| Title | User Engagement With Corrie App as Assessed by the User Engagement Scale |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 102 participants completed the survey at 30 days post-discharge |
| Arm/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 102 |
| Mean (Standard Deviation) [score on a scale] |
3.36
(0.57)
|
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 138 |
| Median (Inter-Quartile Range) [Number of app interactions/participant] |
213
|
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 138 |
| Median (Inter-Quartile Range) [days] |
12
|
| Title | Patient Activation as Assessed by the Patient Activation Measure |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| At 3-days post discharge only 94 participants completed the survey while at 30 days post-discharge 103 participants completed the survey. |
| Arm/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 103 |
| 3 days post-discharge |
71.9
(15.7)
|
| 30 days post-discharge |
71.7
(16.6)
|
| Title | Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 102 participants completed the survey at 30 days post-discharge. |
| Arm/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 102 |
| Complete Adherence |
81
40.5%
|
| Near Complete Adherence |
21
10.5%
|
| Title | Cardiac Medication Adherence as Assessed by Smartphone App Usage Data |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 135 |
| Number (95% Confidence Interval) [percentage of any CVD meds marked taken] |
87
|
| Title | Medication Adherence as Assessed by Smartwatch App Usage Data |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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). |
| Arm/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 0 |
| Title | Number of Participants Who Had Emergency Department Visits Within 30-days Post Hospital Discharge |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Corrie Digital Health Platform Group | Historical Comparison Group |
|---|---|---|
| Arm/Group Description | 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. | Receives the standard of care |
| Measure Participants | 164 | 664 |
| Count of Participants [Participants] |
13
6.5%
|
39
4.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Corrie Digital Health Platform Group, Historical Comparison Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.33 |
| Comments | The a priori threshold for statistical significance was <0.05. | |
| Method | Regression, Cox | |
| Comments | Adjusting for hospital site and a propensity score inclusive of individual level baseline characteristics. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.45 | |
| Confidence Interval |
(2-Sided) 95% 0.69 to 2.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Hospital Observations |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Unable to obtain this data from hospital administrative data sets. Data was not collected. |
| Arm/Group Title | Corrie Digital Health Platform Group | Historical Comparison Group |
|---|---|---|
| Arm/Group Description | 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. | Receives the standard of care |
| Measure Participants | 0 | 0 |
| Title | Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 104 participants completed this survey question at 30 days post-discharge. |
| Arm/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 104 |
| 3 appointments attended |
34
17%
|
| 2 appointments attended |
48
24%
|
| 1 appointment attended |
19
9.5%
|
| 0 appointments attended |
3
1.5%
|
| Title | Number of Readmitted Participants Who Had Recurrent Myocardial Infarctions |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Corrie Digital Health Platform Group |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 13 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Deaths Within 30 Days Post Hospital Discharge |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Unable to obtain data from hospital administrative data sets. Data was not collected. |
| Arm/Group Title | Corrie Digital Health Platform Group | Historical Comparison Group |
|---|---|---|
| Arm/Group Description | 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. | Receives the standard of care |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | 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. | |
|---|---|---|
| Adverse Event Reporting Description | 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. | |
| Arm/Group Title | Corrie Digital Health Platform Group | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Corrie Digital Health Platform Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/200 (0.5%) | |
Serious Adverse Events |
||
| Corrie Digital Health Platform Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 13/200 (6.5%) | |
| General disorders | ||
| Inpatient hospital readmission within 30 days post-discharge | 13/200 (6.5%) | |
Other (Not Including Serious) Adverse Events |
||
| Corrie Digital Health Platform Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/200 (0.5%) | |
| General disorders | ||
| Bruising | 1/200 (0.5%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Seth Martin |
|---|---|
| Organization | Johns Hopkins University School of Medicine |
| Phone | (610) 331 - 3842 |
| smart100@jhmi.edu |
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT03760796
Other Study ID Numbers:
- IRB00099938
First Posted:
Nov 30, 2018
Last Update Posted:
Jul 29, 2021
Last Verified:
Jul 1, 2021