mTECHREHAB: Mobile Technology Enabled Corrie Rehabilitation Study

Sponsor

Johns Hopkins University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05238103

Collaborator

American Heart Association (Other), Apple Inc. (Industry)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this randomized clinical trial, the researchers are investigating whether a multi-component virtual cardiac rehabilitation program in addition to usual care will improve cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with atherosclerotic cardiovascular disease compared to usual care.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Myocardial Infarction Myocardial Ischemia Angina Pectoris Coronary Artery Occlusion Coronary Artery Stenosis Stent Bypass Graft Occlusion	Combination Product: Corrie Virtual Cardiac Rehabilitation Program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Cardiovascular Outcomes (mTECH REHAB): A Randomized Clinical Trial

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Corrie Virtual Cardiac Rehabilitation Program Receives Corrie Virtual Cardiac Rehabilitation Program and usual care	Combination Product: Corrie Virtual Cardiac Rehabilitation Program The Corrie Virtual Cardiac Rehabilitation Program is multi dimensional intervention. It consists of the Corrie smartphone app for cardiovascular health optimization which is paired with wristband device (Apple Watch or Fitbit), Bluetooth-enabled Omron blood pressure monitor and exercise resistance bands. The program also includes individualized treatment plan development, setting health goals and communication with trained Corrie Health Coach. Furthermore, the intervention includes motivational text messages sent to participants throughout the study to aid with risk factor modification.
No Intervention: Usual Care Receives usual care. Usual care is defined as care according to the patients care team's standard practice

Arm

Intervention/Treatment

Experimental: Corrie Virtual Cardiac Rehabilitation Program

Receives Corrie Virtual Cardiac Rehabilitation Program and usual care

Combination Product: Corrie Virtual Cardiac Rehabilitation Program

The Corrie Virtual Cardiac Rehabilitation Program is multi dimensional intervention. It consists of the Corrie smartphone app for cardiovascular health optimization which is paired with wristband device (Apple Watch or Fitbit), Bluetooth-enabled Omron blood pressure monitor and exercise resistance bands. The program also includes individualized treatment plan development, setting health goals and communication with trained Corrie Health Coach. Furthermore, the intervention includes motivational text messages sent to participants throughout the study to aid with risk factor modification.

No Intervention: Usual Care

Receives usual care. Usual care is defined as care according to the patients care team's standard practice

Outcome Measures

Primary Outcome Measures

The difference in physical activity as measured by 6 minute walk test [12 weeks]
Conducted on ground level timed for 6 minutes and measuring distance walked in meters and compared at 12 week follow up between intervention vs control arm.

Secondary Outcome Measures

The difference in Low Density Lipoprotein - Cholesterol (LDL -C) control as measured by the level of LDL - C [12 weeks]
LDL cholesterol level measured (in mg/dl) at 12 week follow up visit and compared between the intervention vs control arms.
The difference in cardiovascular health as measured by composite cardiovascular health metric for secondary prevention [12 weeks]
The difference in the composite score of cardiovascular health metric for secondary prevention (adapted from American Heart Association's Life Simple 7) in the intervention vs control arm. The score ranges from 0 to 14 with higher score indicating better cardiovascular health.
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 [12 weeks]
Proportion of participants attending 12 sessions of total cardiac rehabilitation (in person or off site) within 90 days of a cardiovascular event in intervention arm vs control arm.
The difference in physical activity as measured by 6 minute walk test [12 weeks]
Conducted on ground level timed for 6 minutes and measuring distance walked in meters and compared at 12 week follow up between intervention vs control arm.
The difference in quality of life as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 [12 weeks]
The 10-item patient-reported questionnaire administered at 12 weeks follow up in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
The difference in blood pressure as measured by systolic blood pressure [12 weeks]
Measured by study staff in millimeters of mercury (mmHg) and comparing mean values between intervention and control arm.
The difference in blood pressure as measured by diastolic blood pressure [12 weeks]
Measured by study staff (in mmHg) and comparing mean values between intervention and control arm.
The difference in adiposity as measured by waist circumference [12 weeks]
The difference in mean waist circumference at 12 weeks follow up, measured in centimeters (cm) by study staff.
The difference in body weight as measured by mean body mass index [12 weeks]
As measured by study staff. BMI = weight (kg) / height in meters squared (m^2).
The difference in glucose control as measured by glycosylated hemoglobin (Hb A1c) levels [12 weeks]
Hb A1c level (percentage) measured at 12 week follow up visit and compared between the intervention vs control arms.
The difference in lipid profile as measured by mean total cholesterol level [12 weeks]
Total cholesterol level measured at 12 week follow up visit and compared between the intervention vs control arms.
The difference in lipid profile as measured by mean Triglyceride level [12 weeks]
Triglyceride level measured in mg/dL at 12 week follow up visit and compared between the intervention vs control arms.
The difference in lipid profile as measured by mean High Density Lipoprotein - Cholesterol (HDL - C) level [12 weeks]
High density lipoprotein level measured in mg/dL at 12 week follow up visit and compared between the intervention vs control arms.
Difference in smoking rates as measured by the proportion of current tobacco users [12 weeks]
The difference in proportion of participants who are current tobacco users at 12 weeks per patient report.
The difference in diet as measured by Rate Your Plate score [12 weeks]
A 27 item scale administered at 12 weeks with the following scoring system: 27-45: There are many ways you can make your eating habits healthier. 46-63: There are some ways you can make your eating habits healthier. 64-81: You are making many healthy choices.
The difference in depressive symptoms as measured by Patient Health Questionnaire 8 (PHQ 8) [12 weeks]
The 8 item questionnaire administered at 12 weeks with the following scoring system: A score of 10 or greater is considered major depression, 20 or more is severe major depression.
The difference in anxiety level as measured by Generalized Anxiety Disorder 7 (GAD 7) [12 weeks]
The 7-item questionnaire administered at 12 weeks follow up with the following scoring system. Each item is assigned scores of 0, 1, 2, and 3 to the response categories. GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety
The difference in anxiety level as measured by Perceived Stress Score (PSS -10) [12 weeks]
The 10 item questionnaire administered at 12 weeks follow up. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
The difference in patient activation as measured by Patient Activation Measure 10 (PAM 10) [12 weeks]
The 10-item five-point Likert scale for assessing patient activation at 12 weeks follow up 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.
The difference in Health Literacy as measured by The (e) Health Literacy Scale (eHEALS) [12 weeks]
The 8 item scale administered at 12 weeks follow up. Total scores of the eHEALS range from 8 to 40, with higher scores representing higher self-perceived (e) Health literacy.
The difference in safety outcomes as measured by the difference in number of patients requiring hospitalization [12 weeks]
Hospitalization as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
The difference in safety outcomes as measured by the difference in number of patients Requiring emergency room visits [12 weeks]
Emergency room visits as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
The difference in safety outcomes as measured by the difference in number of patients with Myocardial infarction [12 weeks]
Myocardial infarction as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
The difference in safety outcomes as measured by the difference in number of patients with stroke [12 weeks]
Stroke as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
The difference in safety outcomes as measured by the difference in number of patients who died [12 weeks]
Death as reported in electronic health record or via caregiver report, verified by death certificates or health records at 12 weeks follow up.
The difference in cognitive function as assessed by Montreal Cognitive Assessment (MoCA) [12 weeks]
The 30 item test, administered at 12 weeks follow up. Scores on the MoCA range from 0 to 30. A score of 26 and higher is considered normal.
The difference in engagement in in-person cardiac rehabilitation sessions as measured by number of individuals completing in-person cardiac rehabilitation sessions [12 weeks]
Number of individuals completing 2, 12, 24 and 36 in person cardiac rehabilitation sessions at 12 weeks follow up.
Cost of Care as assessed by a Markov Model of Cost-effectiveness [12 weeks]
The hospital costs (in US dollars) for emergency department (ED) visits and hospital readmissions will be compared between Corrie Virtual Cardiac Rehabilitation Program and usual care groups at 12 weeks follow up.
User Engagement as assessed by total number of interactions [12 weeks]
Total number of interactions in the smartphone app per participant, collected via the Corrie Health Platform User Analytics at 12 weeks follow up (only assessed in intervention arm).
User Engagement as assessed by overall amount of time spent using the smartphone app [12 weeks]
Overall amount of time spent using the smartphone app per participant, collected via the Corrie Health Platform User Analytics at 12 weeks follow up (only assessed in intervention arm).
User Satisfaction as assessed by modified system usability scale [12 weeks]
A 10-item five-point Likert scale for assessing systems usability of Corrie Virtual Cardiac Rehabilitation Program at 12 weeks follow up 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. The investigators will administer system usability scale for different features of Corrie Virtual Cardiac Rehabilitation Program.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, and coronary artery angioplasty/stenting.

Exclusion Criteria

Non-English or Spanish speaking
LDL - Cholesterol level <70 mg/dL
Functional capacity <=3 Metabolic equivalents (METs)
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 (SBP >200 mmHg or diastolic BP >110mmHg)
Mental impairment leading to inability to cooperate with study procedures
Untreated high degree atrioventricular block
Atrial fibrillation with uncontrolled ventricular rate
History of cardiac arrest, sudden death, myocardial infarction or cardiac surgery complications of cardiogenic shock and/or congestive heart failure and/or signs/symptoms of post-procedure ischemia
Left ventricular ejection fraction <35%
Clinically significant depression or depressive symptoms (PHQ 8 score >10)
Visual or hearing impairment which precludes the use of the intervention
Presence of cardiac defibrillator
Incomplete revascularization procedure
High Fall risk (assessed by Johns Hopkins Fall Risk Assessment Tool) (38)
Pregnancy
If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member will return at a later date to determine whether this status has changed.