Clinical trial NCT05238103: Impact of a Corrie Cardiac Rehabilitation Program
Official title: Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Outcomes (mTECH-Rehab): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Infarction
Myocardial Ischemia
Coronary Artery Occlusion
Coronary Artery Stenosis Stent
Bypass Graft Occlusion
Valve Heart Disease
Keywords: digital health
smartphone app
self-management
guideline adherence
behavior modification
community engagement
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Apple Inc.
First posted: 2022-02-14
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this randomized clinical trial, the researchers are investigating whether a multi-component virtual/hybrid cardiac rehabilitation program will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with myocardial infarction, received a coronary stent, underwent heart surgery or catheter-based valve replacement, as compared to traditional, center-based cardiac rehabilitation.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Individuals admitted to the hospital for the following conditions or interventions during the index admission: Acute myocardial infarction (STEMI or NSTEMI type 1), Coronary artery bypass grafting (CABG), and Coronary artery angioplasty/stenting (PCI), Heart valve surgery, catheter-based aortic valve replacement (TAVR).

Exclusion Criteria

* Non-English speaking
* Symptomatic severe aortic stenosis or other severe valvular disease
* Physical disability that would preclude safe and adequate exercise performance
* Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of \>25 mmHg
* Known aortic dissection
* Severe resting arterial hypertension (Systolic blood pressure \>200 mmHg or diastolic BP \>110mmHg) at baseline assessment
* Mental impairment leading to inability to cooperate with study procedures
* Untreated high degree atrioventricular block
* Atrial fibrillation with uncontrolled ventricular rate (Heart rate \>110 at rest) at baseline assessment
* History of cardiac arrest or sudden death
* Myocardial infarction or cardiac surgery complications with cardiogenic shock and/or congestive heart failure and/or signs/symptoms of post-procedure ischemia
* Left ventricular ejection fraction \<40%
* History of Clinically significant depression
* Visual or hearing impairment which precludes the use of the intervention
* Presence of cardiac defibrillator
* Incomplete revascularization procedure
* History of one or more episodes of falls in the last year
* Pregnancy

  * If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member may return at a later date to determine whether this status has changed.

Primary outcomes:
measure: The difference in functional status as measured by 6 minute walk test
timeFrame: 12 weeks after randomization
Secondary outcomes:
measure: The difference in Low Density Lipoprotein - Cholesterol (LDL -C) control as measured by the level of LDL - C
timeFrame: 12 weeks after randomization
measure: The difference in cardiovascular health as measured by composite cardiovascular health Composite metric for secondary prevention
timeFrame: 12 weeks after randomization
measure: The difference in cardiac rehabilitation engagement as measured by the proportion of participants attending 12 sessions of total cardiac rehabilitation attended (in person or off site) within 90 days of a cardiovascular event
timeFrame: 12 weeks after randomization
measure: The difference in quality of life as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10
timeFrame: 12 weeks after randomization
measure: The difference in blood pressure as measured by systolic blood pressure
timeFrame: 12 weeks after randomization
measure: The difference in blood pressure as measured by diastolic blood pressure
timeFrame: 12 weeks after randomization
measure: The difference in adiposity as measured by waist circumference
timeFrame: 12 weeks after randomization
measure: The difference in body weight as measured by mean body mass index
timeFrame: 12 weeks after randomization
measure: The difference in glucose control as measured by glycosylated hemoglobin (Hb A1c) levels
timeFrame: 12 weeks after randomization
measure: The difference in lipid profile as measured by mean total cholesterol level
timeFrame: 12 weeks after randomization
measure: The difference in lipid profile as measured by mean High Density Lipoprotein - Cholesterol (HDL - C) level
timeFrame: 12 weeks after randomization
measure: Difference in smoking rates as measured by the proportion of current tobacco users
timeFrame: 12 weeks after randomization
measure: The difference in diet as measured by Rate Your Plate score
timeFrame: 12 weeks after randomization
measure: The difference in depressive symptoms as measured by Patient Health Questionnaire 8 (PHQ 8)
timeFrame: 12 weeks after randomization
measure: The difference in anxiety level as measured by Generalized Anxiety Disorder 7 (GAD 7)
timeFrame: 12 weeks after randomization
measure: The difference in anxiety level as measured by Perceived Stress Scale (PSS -10)
timeFrame: 12 weeks after randomization
measure: The difference in patient activation as measured by Patient Activation Measure 10 (PAM 10)
timeFrame: 12 weeks after randomization
measure: The difference in Health Literacy as measured by The (e) Health Literacy Scale (eHEALS)
timeFrame: 12 weeks after randomization
measure: The difference in safety outcomes as measured by the difference in number of patients requiring hospitalization
timeFrame: 12 weeks after randomization
measure: The difference in safety outcomes as measured by the difference in number of patients Requiring emergency room visits
timeFrame: 12 weeks after randomization
measure: The difference in safety outcomes as measured by the difference in number of patients with Myocardial infarction
timeFrame: 12 weeks after randomization
measure: The difference in safety outcomes as measured by the difference in number of patients with stroke
timeFrame: 12 weeks after randomization
measure: The difference in safety outcomes as measured by the difference in number of patients who died
timeFrame: 12 weeks after randomization
measure: The difference in engagement in in-person cardiac rehabilitation sessions as measured by number of individuals completing in-person cardiac rehabilitation sessions
timeFrame: 12 weeks after randomization
measure: Cost of Care as assessed by a Markov Model of Cost-effectiveness
timeFrame: 12 weeks after randomization
measure: User Engagement as assessed by total number of interactions with smartphone application
timeFrame: 12 weeks after randomization
measure: User Engagement as assessed by overall amount of time spent using the smartphone app
timeFrame: 12 weeks after randomization
measure: User Satisfaction as assessed by modified system usability scale
timeFrame: 12 weeks after randomization
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lena Mathews, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Isakadze N, Kim CH, Marvel FA, Ding J, MacFarlane Z, Gao Y, Spaulding EM, Stewart KJ, Nimbalkar M, Bush A, Broderick A, Gallagher J, Molello N, Commodore-Mensah Y, Michos ED, Dunn P, Hanley DF, McBee N, Martin SS, Mathews L. Rationale and Design of the mTECH-Rehab Randomized Controlled Trial: Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Health. J Am Heart Assoc. 2024 Jan 16;13(2):e030654. doi: 10.1161/JAHA.123.030654. Epub 2024 Jan 16.