Acute Myocardial InfarctionMiCORENCT03760796
Myocardial Infarction, COmbined-device, Recovery Enhancement Study
A study testing Corrie Health Digital Platform in people with Acute Myocardial Infarction and Coronary Artery Disease, run by Johns Hopkins University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- Corrie Health Digital Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2016to 17 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted for acute myocardial infarction (STEMI or Type 1 NSTEMI)
- 18 years or older
- English-speaking
- Own any type of smartphone
- Admitted for acute myocardial infarction (STEMI or NSTEMI)
- 18 years or older
- English-speaking
Who cannot join
- 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
- None
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Reading Hospital-Tower Health
Reading, Pennsylvania, 19611
About this study
Official title: The Johns Hopkins Myocardial Infarction, COmbined-device, Recovery Enhancement (MiCORE) Study
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.
- Conditions
- Acute Myocardial Infarction, Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction
- Being tested
- Corrie Health Digital Platform
- Keywords
- readmission, cardiovascular disease prevention, cardiovascular disease risk factors, cost-effectiveness, heart attack, acute myocardial infarction, secondary prevention, digital health, smartphone app, self-management, guideline adherence, behavior modification
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corrie Health Digital PlatformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Corrie Health Digital Platform group | Experimental | Receives the Corrie Health intervention plus the standard of care Receives: Device: Corrie Health Digital Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Readmitted Within 30-days Post Hospital Discharge
Number of participants readmitted within 30-days post hospital discharge in the Corrie Digital Health Group as compared to the Historical Standard of Care Comparison group, collected from hospital administrative databases.
Measured: 30-days post hospital discharge
Secondary outcomes (19)
Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness
We estimated typical costs associated with readmissions or death of acute myocardial infarction (AMI) patients discharged with standard practices using 2014 US hospital costs from the Agency for Healthcare Research and Quality (AHRQ). The hospital cost (in US dollars) for unplanned 30-day readmission is presented for the Corrie Digital Health Platform Group and the Historical Comparison Group. The reported number is the estimated cost per readmission per participant since the exact cost of the readmission for each patient who was readmitted within 30-days wasn't available. No measure of central tendency is available.
Measured: 30 days post hospital discharge
In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)
Among participants in the Corrie Digital Health group, a nine-item five-point Likert scale for assessing in-hospital care satisfaction 3 days post-discharge is used with scoring from 1 "strongly disagree" to 5 "strongly agree", with higher scores meaning participants were more satisfied with the care received. A total score of these nine items is calculated with possible total scores ranging from 9 to 45.
Measured: 3 days post hospital discharge
In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (Summary Score)
Among participants in the Corrie Digital Health group, a nine-item five-point Likert scale for assessing in-hospital care satisfaction 3 days post-discharge is used with scoring from 1 "strongly disagree" to 5 "strongly agree", with higher scores meaning participants were more satisfied with the care received. A total score of these nine items is calculated with possible total scores ranging from 9 to 45.
Measured: 3 days post hospital discharge
In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Dichotomous Item)
Among participants in the Corrie Digital Health group, one additional item, not on the five-point Likert scale, for assessing in-hospital care satisfaction 3 days post-discharge asked if they received information in writing about what symptoms or health problems to look out for after leaving the hospital (Yes/No).
Measured: 3 days post hospital discharge
In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Continuous Item)
Among participants in the Corrie Digital Health group, one additional item, not on the five-point Likert scale, for assessing in-hospital care satisfaction 3 days post-discharge asked them to provide an overall hospital rating on a 1-10 sliding scale with a higher score indicating a higher overall hospital rating.
Measured: 3 days post hospital discharge
Perceived Usability of Corrie as Assessed by the Systems Usability Scale
Among participants in the Corrie Digital Health group, a 10-item five-point Likert scale for assessing systems usability of Corrie both 3 and 30 days post-discharge is used with scoring from 0 to 4 and higher scores meaning patients perceive the system as having global usability. The total score reference range is from 0 to 100, where lower scores indicate lower perceived application usability.
Measured: 3 and 30 days post hospital discharge
Perceived Corrie App Satisfaction as Assessed by a Study Team Developed Scale
Among participants in the Corrie Digital Health group, a five-item five-point Likert scale for assessing participant satisfaction with Corrie as a tool to improve acute myocardial infarction recovery 3 and 30 days post-discharge is used with scoring from 1 to 5 and higher scores meaning more satisfaction with Corrie. Total possible scores ranging from 5 to 25, where higher scores indicate greater Corrie app satisfaction.
Measured: 3 and 30 days post hospital discharge
User Engagement With Corrie App as Assessed by the User Engagement Scale
Among participants in the Corrie Digital Health group, a 29-item five-point Likert scale for assessing the subjective experience of user engagement with Corrie 30 days post discharge is used with scoring ranging from 1 to 5 and higher scores reflecting higher perceived user engagement. The total subjective user engagement score was calculated by diving the sum of all items by 29, resulting in a range of potential total scores from 1 to 5.
Measured: 30 days post hospital discharge
User Engagement With Corrie Health App as Assessed by the Total Number of Interactions Per Participant in the Smartphone App, Collected Via Corrie Health Platform User Analytics
The total number of app interactions is a behavioral manifestation of user engagement and is monitored through app usage data. The total number of app interactions consisted of: number of BP, heart rate,weight, mood, and step count recordings; number of medications tracked; and number of educational articles and videos viewed over the study period.
Measured: Throughout the study period for app usage up to 30 days post-discharge from the hospital
User Engagement With Corrie Health App as Assessed by the Overall Amount of Time Spent Using the App, Collected Via Corrie Health Platform App User Analytics
The overall amount of time (days) spent using the app is a behavioral manifestation of user engagement and is monitored through app usage data and collected via Corrie Health Platform app user analytics.
Measured: Throughout the study period for app usage up to 30 days post-discharge from the hospital
Patient Activation as Assessed by the Patient Activation Measure
Among participants in the Corrie Digital Health group, the 10-item five-point Likert scale for assessing patient activation 3 and 30 days post-discharge is used with scoring ranging from 1 to 5 and higher scores indicating the patient possesses the necessary knowledge, skills, and confidence needed for self-care. The total score reference range is from 0 to 100, where lower scores indicate lower patient activation.
Measured: 3 and 30 days post hospital discharge
Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale
Among participants in the Corrie Digital Health group, the eight-item four-point Likert scale for assessing cardiac medication adherence 30 days post-discharge is used with scoring ranging from 1 to 4 and lower scores indicating better adherence. Total possible scores could range from 8 to 32 with lower scores indicating better adherence. The total cardiac medication adherence score was dichotomized into completely cardiac medication adherent and near completely cardiac medication adherent, based on the median score.
Measured: 30 days post hospital discharge
Cardiac Medication Adherence as Assessed by Smartphone App Usage Data
Cardiac medication adherence (beta-blockers, anti-platelets, statins) is measured from the smartphone app usage data as the percentage of cardiac medications marked as "taken".
Measured: Throughout the study period for app usage up to 30 days post-discharge from the hospital
Medication Adherence as Assessed by Smartwatch App Usage Data
Medication adherence is measured from the smartwatch app usage data as percent of pills marked as taken.
Measured: Throughout the study period for app usage up to 30 days post-discharge from the hospital
Number of Participants Who Had Emergency Department Visits Within 30-days Post Hospital Discharge
Number of participants who had Emergency department visits (at Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center) within 30-days post hospital discharge, that did not result in readmission, in the Corrie Digital Health Group as compared to the Historical Standard of Care Comparison group, collected from hospital administrative databases.
Measured: 30 days post hospital discharge
Number of Hospital Observations
Number of hospital observations within 30-days post hospital discharge in the Corrie Digital Health Group as compared to the Historical Standard of Care Comparison group, collected from hospital administrative databases.
Measured: 30 days post hospital discharge
Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team
Among participants in the Corrie Digital Health group, the investigators are querying participants in the surveys sent out 30 days post-discharge as to whether participants attended an appointment with a primary care provider, cardiologist, and/or cardiac rehab. A point is given to each appointment attended with scores raging from 0 to 3.
Measured: 30 days post hospital discharge
Number of Readmitted Participants Who Had Recurrent Myocardial Infarctions
Number of readmitted participants who had Recurrent myocardial infarctions in the Corrie Digital Health Group. Participants who had an all-cause 30-day readmission in the Corrie group, as identified by hospital administrative datasets, underwent further chart review to determine if the cause of readmission was a recurrent myocardial infarction.
Measured: 30 days post hospital discharge
Number of Deaths Within 30 Days Post Hospital Discharge
Death within 30-days post hospital discharge in the Corrie Digital Health Group as compared to the Historical Standard of Care Comparison group, collected from hospital administrative databases.
Measured: 30 days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Oct 2016
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Apple Inc., iHealth
- Responsible party
- Sponsor
- Investigators
- Seth S Martin, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760796
- Sponsor's protocol ID
- IRB00099938
- Acronym
- MiCORE
- Status last verified
- Jul 2021
- First submitted
- 21 Nov 2018
- Last updated
- 29 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31043065Shah 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.
PubMed 31094337Marvel 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.
PubMed 31758761Shah LM, Ding J, Spaulding EM, Yang WE, Lee MA, Demo R, Marvel FA, Martin SS. Sociodemographic Characteristics Predicting Digital Health Intervention Use After Acute Myocardial Infarction. J Cardiovasc Transl Res. 2021 Oct;14(5):951-961. doi: 10.1007/s12265-021-10098-9. Epub 2021 May 17.
PubMed 33999374Shan R, Ding J, Weng D, Spaulding EM, Wongvibulsin S, Lee MA, Demo R, Marvel FA, Martin SS. Early blood pressure assessment after acute myocardial infarction: Insights using digital health technology. Am J Prev Cardiol. 2020 Sep;3:100089. doi: 10.1016/j.ajpc.2020.100089. Epub 2020 Sep 17.
PubMed 32964212Yang WE, Spaulding EM, Lumelsky D, Hung G, Huynh PP, Knowles K, Marvel FA, Vilarino V, Wang J, Shah LM, Xun H, Shan R, Wongvibulsin S, Martin SS. Strategies for the Successful Implementation of a Novel iPhone Loaner System (iShare) in mHealth Interventions: Prospective Study. JMIR Mhealth Uhealth. 2019 Dec 16;7(12):e16391. doi: 10.2196/16391.
PubMed 31841115Hung G, Yang WE, Marvel FA, Martin SS. Mobile health application platform 'Corrie' personalises and empowers the heart attack recovery patient experience in the hospital and at home for an underserved heart attack survivor. BMJ Case Rep. 2020 Feb 17;13(2):e231801. doi: 10.1136/bcr-2019-231801.
PubMed 32071124Marvel FA, Spaulding EM, Lee MA, Yang WE, Demo R, Ding J, Wang J, Xun H, Shah LM, Weng D, Carter J, Majmudar M, Elgin E, Sheidy J, McLin R, Flowers J, Vilarino V, Lumelsky DN, Bhardwaj V, Padula WV, Shan R, Huynh PP, Wongvibulsin S, Leung C, Allen JK, Martin SS. Digital Health Intervention in Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2021 Jul;14(7):e007741. doi: 10.1161/CIRCOUTCOMES.121.007741. Epub 2021 Jul 15.
PubMed 34261332Bhardwaj V, Spaulding EM, Marvel FA, LaFave S, Yu J, Mota D, Lorigiano TJ, Huynh PP, Shan R, Yesantharao PS, Lee MA, Yang WE, Demo R, Ding J, Wang J, Xun H, Shah L, Weng D, Wongvibulsin S, Carter J, Sheidy J, McLin R, Flowers J, Majmudar M, Elgin E, Vilarino V, Lumelsky D, Leung C, Allen JK, Martin SS, Padula WV. Cost-effectiveness of a Digital Health Intervention for Acute Myocardial Infarction Recovery. Med Care. 2021 Nov 1;59(11):1023-1030. doi: 10.1097/MLR.0000000000001636.
PubMed 34534188
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Johns Hopkins Myocardial Infarction, COmbined-device, Recovery Enhancement (MiCORE) Study
- ClinicalTrials.gov ID
- NCT03760796
- Acronym / sponsor ID
- MiCORE / IRB00099938
- Conditions
- Acute Myocardial Infarction, Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction
- Keywords
- readmission, cardiovascular disease prevention, cardiovascular disease risk factors, cost-effectiveness, heart attack, acute myocardial infarction, secondary prevention, digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Apple Inc., iHealth
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Posted 4 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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)
| Arm | Type | Receives |
|---|---|---|
| Corrie Health Digital Platform group | Experimental | Device: Corrie Health Digital PlatformReceives the Corrie Health intervention plus the standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Admitted for acute myocardial infarction (STEMI or Type 1 NSTEMI)
- 18 years or older
- English-speaking
- Own any type of smartphone
- Admitted for acute myocardial infarction (STEMI or NSTEMI)
Key exclusion criteria (4 listed)
- 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
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corrie Health Digital PlatformThe 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. | Device | Corrie Health Digital Platform group |
Primary outcome
Number of Participants Readmitted Within 30-days Post Hospital Discharge
Time frame: 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.
19 secondary outcomes
Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness
Time frame: 30 days post hospital discharge
In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (9 Items)
Time frame: 3 days post hospital discharge
In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (Summary Score)
Time frame: 3 days post hospital discharge
In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Dichotomous Item)
Time frame: 3 days post hospital discharge
In-hospital Care Satisfaction as Assessed by a Subset of the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (1 Continuous Item)
Time frame: 3 days post hospital discharge
Perceived Usability of Corrie as Assessed by the Systems Usability Scale
Time frame: 3 and 30 days post hospital discharge
Perceived Corrie App Satisfaction as Assessed by a Study Team Developed Scale
Time frame: 3 and 30 days post hospital discharge
User Engagement With Corrie App as Assessed by the User Engagement Scale
Time frame: 30 days post hospital discharge
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
Time frame: Throughout the study period for app usage up to 30 days post-discharge from the hospital
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
Time frame: Throughout the study period for app usage up to 30 days post-discharge from the hospital
Patient Activation as Assessed by the Patient Activation Measure
Time frame: 3 and 30 days post hospital discharge
Cardiac Medication Adherence as Assessed by the Adherence to Refills and Medications Scale Subscale
Time frame: 30 days post hospital discharge
Cardiac Medication Adherence as Assessed by Smartphone App Usage Data
Time frame: Throughout the study period for app usage up to 30 days post-discharge from the hospital
Medication Adherence as Assessed by Smartwatch App Usage Data
Time frame: Throughout the study period for app usage up to 30 days post-discharge from the hospital
Number of Participants Who Had Emergency Department Visits Within 30-days Post Hospital Discharge
Time frame: 30 days post hospital discharge
Number of Hospital Observations
Time frame: 30 days post hospital discharge
Attendance of Follow-up Appointments as Assessed by Post-discharge Survey Developed by Study Team
Time frame: 30 days post hospital discharge
Number of Readmitted Participants Who Had Recurrent Myocardial Infarctions
Time frame: 30 days post hospital discharge
Number of Deaths Within 30 Days Post Hospital Discharge
Time frame: 30 days post hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31043065Spaulding 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.
- Background: PubMed 31094337Shah 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.
- Background: PubMed 31758761Marvel 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.
- Results publication: PubMed 33999374Shah LM, Ding J, Spaulding EM, Yang WE, Lee MA, Demo R, Marvel FA, Martin SS. Sociodemographic Characteristics Predicting Digital Health Intervention Use After Acute Myocardial Infarction. J Cardiovasc Transl Res. 2021 Oct;14(5):951-961. doi: 10.1007/s12265-021-10098-9. Epub 2021 May 17.
- Results publication: PubMed 32964212Shan R, Ding J, Weng D, Spaulding EM, Wongvibulsin S, Lee MA, Demo R, Marvel FA, Martin SS. Early blood pressure assessment after acute myocardial infarction: Insights using digital health technology. Am J Prev Cardiol. 2020 Sep;3:100089. doi: 10.1016/j.ajpc.2020.100089. Epub 2020 Sep 17.
- Results publication: PubMed 31841115Yang WE, Spaulding EM, Lumelsky D, Hung G, Huynh PP, Knowles K, Marvel FA, Vilarino V, Wang J, Shah LM, Xun H, Shan R, Wongvibulsin S, Martin SS. Strategies for the Successful Implementation of a Novel iPhone Loaner System (iShare) in mHealth Interventions: Prospective Study. JMIR Mhealth Uhealth. 2019 Dec 16;7(12):e16391. doi: 10.2196/16391.
- Results publication: PubMed 32071124Hung G, Yang WE, Marvel FA, Martin SS. Mobile health application platform 'Corrie' personalises and empowers the heart attack recovery patient experience in the hospital and at home for an underserved heart attack survivor. BMJ Case Rep. 2020 Feb 17;13(2):e231801. doi: 10.1136/bcr-2019-231801.
- Results publication: PubMed 34261332Marvel FA, Spaulding EM, Lee MA, Yang WE, Demo R, Ding J, Wang J, Xun H, Shah LM, Weng D, Carter J, Majmudar M, Elgin E, Sheidy J, McLin R, Flowers J, Vilarino V, Lumelsky DN, Bhardwaj V, Padula WV, Shan R, Huynh PP, Wongvibulsin S, Leung C, Allen JK, Martin SS. Digital Health Intervention in Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2021 Jul;14(7):e007741. doi: 10.1161/CIRCOUTCOMES.121.007741. Epub 2021 Jul 15.
- Derived from this study: PubMed 34534188Bhardwaj V, Spaulding EM, Marvel FA, LaFave S, Yu J, Mota D, Lorigiano TJ, Huynh PP, Shan R, Yesantharao PS, Lee MA, Yang WE, Demo R, Ding J, Wang J, Xun H, Shah L, Weng D, Wongvibulsin S, Carter J, Sheidy J, McLin R, Flowers J, Majmudar M, Elgin E, Vilarino V, Lumelsky D, Leung C, Allen JK, Martin SS, Padula WV. Cost-effectiveness of a Digital Health Intervention for Acute Myocardial Infarction Recovery. Med Care. 2021 Nov 1;59(11):1023-1030. doi: 10.1097/MLR.0000000000001636.
- Corrie Health Digital Platform for Self-Management in Secondary Prevention After Acute Myocardial InfarctionLink provided by the sponsor.
- Technical Guidance for Clinicians Interested in Partnering With Engineers in Mobile Health Development and EvaluationLink provided by the sponsor.
- Digital Health Innovation: A Toolkit to Navigate From Concept to Clinical TestingLink provided by the sponsor.
- Sociodemographic Characteristics Predicting Digital Health Intervention Use After Acute Myocardial InfarctionLink provided by the sponsor.
- Strategies for the Successful Implementation of a Novel iPhone Loaner System (iShare) in mHealth Interventions: Prospective StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Acute Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth S Martin, MD, MHS principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corrie Health Digital Platform in people with Acute Myocardial Infarction and Coronary Artery Disease, run by Johns Hopkins University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Readmitted Within 30-days Post Hospital Discharge (time frame: 30-days post hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03760796, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.