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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

200

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach

1 country

4 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

Study Start

First participant enrolled

October 1, 2016

Completed

2.1 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2018

Completed

9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

February 4, 2021

Completed

Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

3.2 years

First QC Date

November 21, 2018

Results QC Date

December 15, 2020

Last Update Submit

July 27, 2021

Conditions

Acute Myocardial Infarction Coronary Artery Disease Acute Coronary Syndrome Myocardial Infarction

Keywords

readmissioncardiovascular disease preventioncardiovascular disease risk factorscost-effectivenessheart attackacute myocardial infarctionsecondary preventiondigital healthsmartphone appself-managementguideline adherencebehavior modification

Outcome Measures

Primary Outcomes (1)

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.
30-days post hospital discharge

Secondary Outcomes (19)

Cost-effectiveness as Assessed by a Markov Model of Cost-effectiveness
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)
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)
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)
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)
3 days post hospital discharge
+14 more secondary outcomes

Study Arms (1)

Corrie Health Digital Platform group

EXPERIMENTAL

Receives the Corrie Health intervention plus the standard of care

Device: Corrie Health Digital Platform

Interventions

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.

Corrie Health Digital Platform group

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Admitted for acute myocardial infarction (STEMI or Type 1 NSTEMI)
years or older
English-speaking
Own any type of smartphone

You may not qualify if:

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
Admitted for acute myocardial infarction (STEMI or NSTEMI)
years or older
English-speaking
None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Johns Hopkins Universitylead
Apple Inc.collaborator
iHealthcollaborator

Study Sites (4)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Reading Hospital-Tower Health

Reading, Pennsylvania, 19611, United States

Location

Related Publications (9)

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.
PMID: 31043065BACKGROUND
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.
PMID: 31094337BACKGROUND
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.
PMID: 31758761BACKGROUND
Shah 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.
PMID: 33999374RESULT
Shan 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.
PMID: 32964212RESULT
Yang 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.
PMID: 31841115RESULT
Hung 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.
PMID: 32071124RESULT
Marvel 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.
PMID: 34261332RESULT
Bhardwaj 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.
PMID: 34534188DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary SyndromeMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title: Dr. Seth Martin
Organization: Johns Hopkins University School of Medicine

Study Officials

Seth S Martin, MD, MHS
Johns Hopkins University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 30, 2018

Study Start

October 1, 2016

Primary Completion

December 17, 2019

Study Completion

December 17, 2019

Last Updated

July 29, 2021

Results First Posted

February 4, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing: Will not share

Locations

US(4)

Myocardial Infarction, COmbined-device, Recovery Enhancement Study

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (19)

Study Arms (1)

Corrie Health Digital Platform group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (9)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (19)

Study Arms (1)

Corrie Health Digital Platform group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (9)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations