Bypass Graft Occlusion, Coronary Artery Disease, Coronary Artery Occlusion, Coronary Artery Stenosis Stent, Myocardial Infarction, Myocardial Ischemia, Valve Heart Disease
Conditions
Keywords
digital health, smartphone app, self-management, guideline adherence, behavior modification, community engagement
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.
Interventions
COMBINATION_PRODUCTCorrie Hybrid Cardiac Rehabilitation Program
The Corrie Hybrid Cardiac Rehabilitation Program is a multi-component 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.
Sponsors
American Heart Association
Apple Inc.
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute Walking Distance (Meters) | 12 weeks after randomization | Mean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Rehabilitation Engagement | 12 weeks after randomization | Cardiac rehabilitation engagement as measured by number of participants who attended the sessions per category. Grouped by Healthcare Effectiveness Data and Information Set (HEDIS) categories: Initiation (0-12 sessions attended), Engagement 1 (13-24 sessions attended), Engagement 2 (25-36 sessions attended). |
| Cholesterol (LDL-C) Control | 12 weeks after randomization | Cholesterol (LDL-C) control (Cardiovascular secondary health metric component). Ideal (LDL-C \<70mg/dL). Intermediate (LDL-C 70-99 mg/dL). Poor (LDL-C ≥100mg/dL) |
| Diabetes Control | 12 weeks after randomization | Diabetes (HbA1c) control (Cardiovascular secondary health metric component). Ideal (HbA1c \<7% for diabetic, \<5.7% for non-diabetic). Intermediate (HbA1c 7.0-7.9% for diabetic, 5.0-5.9% for non-diabetic). Poor (HbA1c ≥8% for diabetic, ≥6.5% for non-diabetic). |
| Weight (BMI) Categories | 12 weeks after randomization | Weight (BMI) categories (Cardiovascular secondary health metric component). Ideal (BMI \<25 kg/m\^2). Intermediate (BMI 25-29 kg/m\^2). Poor (BMI ≥ 30 kg/m\^2). |
| Physical Activity Categories | 12 weeks after randomization | Physical activity categories (Cardiovascular secondary health metric component). Ideal (≥150 min/wk moderate physical activity, ≥75 min/wk vigorous physical activity). Intermediate (1-149 min/wk moderate physical activity, 1-74 min/wk vigorous physical activity). Poor (No regular exercise). |
| Diet Categories | 12 weeks after randomization | Diet categories (Cardiovascular secondary health metric component). Ideal (Rate Your Plate score 64-81). Intermediate (Rate Your Plate score 46-63). Poor (Rate Your Plate score 27-45). |
| Tobacco Use | 12 weeks after randomization | Tobacco use categories (Cardiovascular secondary health metric component). Ideal (never). Intermediate (Former smoker). Poor (Recent/Current smoker). |
| Composite Cardiovascular Health Metric for Secondary Prevention | 12 weeks after randomization | The cardiovascular health metric for secondary prevention (adapted from American Heart Association's Life Simple 7). The score ranges from 0 to 14 with higher score indicating better cardiovascular health. |
| Blood Pressure (mmHg) | 12 weeks after randomization | Systolic blood pressure and Diastolic blood pressure |
| Low Density Lipoprotein - Cholesterol (LDL-C) | 12 weeks after randomization | LDL cholesterol level (in mg/dl) measured through blood sample drawn at 12 week follow up visit |
| Glycosylated Hemoglobin (HbA1c) | 12 weeks after randomization | Glycosylated hemoglobin (HbA1c) level (%) measured through blood sample drawn at 12 week follow up visit |
| Body Mass Index (kg/m^2) | 12 weeks after randomization | BMI = weight (kg) / height in meters squared (m\^2). Weight and height measured by study staff at study visit. |
| Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 | 12 weeks after randomization | Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10: 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. |
| Blood Pressure Control | 12 weeks after randomization | Blood pressure control (Cardiovascular secondary health metric component). Ideal (SBP \<130 mmHg and DBP \<90 mmHg). Intermediate (SBP 130-139 mmHg or DBP 80-89 mmHg). Poor (SBP ≥140 mmHg or DBP ≥90 mmHg). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anxiety as Assessed by the Generalized Anxiety Disorder 7 | 12 weeks after randomization | The difference in anxiety level as measured by Generalized Anxiety Disorder 7 (GAD 7): 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. |
| Stress as Assessed by the Perceived Stress Scale-10 | 12 weeks after randomization | The difference in stress level as measured by Perceived Stress Scale (PSS -10): 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. |
| Health Literacy as Assessed by the (e) Health Literacy Scale (eHEALS) | 12 weeks after randomization | The difference in Health Literacy as measured by The (e) Health Literacy Scale (eHEALS): 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. |
| Patient Activation as Assessed by the Patient Activation Measure 10 | 12 weeks after randomization | The difference in patient activation as measured by Patient Activation Measure 10 (PAM 10): The 10-item five-point Likert scale for assessing patient activation at 12 weeks follow up, indicating whether the patient possesses the necessary knowledge, skills, and confidence needed for self-care. The total score reference range is from 0 to 100, where higher scores indicate greater patient activation and ability for self-care. |
| User Engagement as Assessed by the Number of App Interactions (Intervention Group Only) | 12 weeks after randomization | 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). |
| Depression as Assessed by the Patient Health Questionnaire 8 | 12 weeks after randomization | The difference in depressive symptoms as measured by Patient Health Questionnaire 8 (PHQ 8): The 8 item questionnaire administered at 12 weeks with the following scoring system: Score range 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression. Note, as an exploratory outcome, only a subgroup of participants responded to this survey request. |
Countries
United States
Participant flow
Recruitment details
Assessed for eligibility: 6,170; Met eligibility criteria: 1,252; Met exclusion criteria: 4,918; Excluded: 993 (Declined to participate: 710, Unable to be contacted: 283).
Pre-assignment details
Drop-out (pre-randomization/run-in) - 57. (Lost to follow up - 32. Developed exclusion criteria -10. Withdrew consent - 8. Financial reason - 5. Unable to undergo safety evaluation - 2). 259 Enrolled. 202 participants randomized.
Participants by arm
| Arm | Count |
|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation. | 101 |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals. | 101 |
| Total | 202 |
Baseline characteristics
| Characteristic | Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Total | Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) |
|---|---|---|---|
| Age, Continuous | 64.6 Years STANDARD_DEVIATION 12.4 | 63.9 Years STANDARD_DEVIATION 12 | 63.3 Years STANDARD_DEVIATION 11.5 |
| Blood Pressure (mmHg) Diastolic blood pressure (mmHg) | 70.7 mmHg STANDARD_DEVIATION 9.8 | 70.8 mmHg STANDARD_DEVIATION 10.1 | 70.9 mmHg STANDARD_DEVIATION 10.5 |
| Blood Pressure (mmHg) Systolic blood pressure (mmHg) | 124.3 mmHg STANDARD_DEVIATION 16.1 | 125.3 mmHg STANDARD_DEVIATION 16.7 | 126.8 mmHg STANDARD_DEVIATION 17.3 |
| Body Mass Index (kg/m^2) | 29.7 kg/m^2 STANDARD_DEVIATION 6 | 29.1 kg/m^2 STANDARD_DEVIATION 5.7 | 28.5 kg/m^2 STANDARD_DEVIATION 5.3 |
| Cardiac Rehabilitation Indication (Disease Category) AMI | 17 Participants | 37 Participants | 20 Participants |
| Cardiac Rehabilitation Indication (Disease Category) CAD without AMI | 44 Participants | 85 Participants | 41 Participants |
| Cardiac Rehabilitation Indication (Disease Category) CAD with VHD | 3 Participants | 5 Participants | 2 Participants |
| Cardiac Rehabilitation Indication (Disease Category) VHD | 37 Participants | 75 Participants | 38 Participants |
| Cardiac Rehabilitation Indication (Disease Category + Treatment Modality) AMI (Medically treated) | 0 Participants | 1 Participants | 1 Participants |
| Cardiac Rehabilitation Indication (Disease Category + Treatment Modality) AMI (Treated with CABG) | 2 Participants | 3 Participants | 1 Participants |
| Cardiac Rehabilitation Indication (Disease Category + Treatment Modality) AMI (Treated with PCI) | 15 Participants | 33 Participants | 18 Participants |
| Cardiac Rehabilitation Indication (Disease Category + Treatment Modality) CAD without AMI (Treated with CABG) | 15 Participants | 26 Participants | 11 Participants |
| Cardiac Rehabilitation Indication (Disease Category + Treatment Modality) CAD without AMI (Treated with PCI) | 29 Participants | 59 Participants | 30 Participants |
| Cardiac Rehabilitation Indication (Disease Category + Treatment Modality) Combined CABG + Heart valve surgery | 3 Participants | 5 Participants | 2 Participants |
| Cardiac Rehabilitation Indication (Disease Category + Treatment Modality) VHD (Treated with Heart valve surgery) | 27 Participants | 62 Participants | 35 Participants |
| Cardiac Rehabilitation Indication (Disease Category + Treatment Modality) VHD (Treated with TAVR) | 10 Participants | 13 Participants | 3 Participants |
| Clinical History Atrial fibrillation | 38 Participants | 66 Participants | 28 Participants |
| Clinical History Coronary artery disease | 75 Participants | 155 Participants | 80 Participants |
| Clinical History Diabetes mellitus | 25 Participants | 44 Participants | 19 Participants |
| Clinical History Heart failure | 15 Participants | 33 Participants | 18 Participants |
| Clinical History Hyperlipidemia | 83 Participants | 171 Participants | 88 Participants |
| Clinical History Hypertension | 76 Participants | 153 Participants | 77 Participants |
| Clinical History Myocardial infarction | 30 Participants | 62 Participants | 32 Participants |
| Clinical History Tobacco use | 2 Participants | 4 Participants | 2 Participants |
| Clinical History Valvular heart disease | 43 Participants | 85 Participants | 42 Participants |
| Heart Rate (beats per minute) | 74.2 beats per minute STANDARD_DEVIATION 12.7 | 73.6 beats per minute STANDARD_DEVIATION 12.6 | 73.1 beats per minute STANDARD_DEVIATION 12.6 |
| Left Ventricular ejection fraction (LVEF) | 58.2 Percentage of LVEF STANDARD_DEVIATION 7.7 | 58.7 Percentage of LVEF STANDARD_DEVIATION 7.2 | 59.2 Percentage of LVEF STANDARD_DEVIATION 6.7 |
| Race/Ethnicity, Customized African American | 8 Participants | 18 Participants | 10 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 11 Participants | 5 Participants |
| Race/Ethnicity, Customized Declined to answer | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 83 Participants | 165 Participants | 82 Participants |
| Sex: Female, Male Female | 33 Participants | 65 Participants | 32 Participants |
| Sex: Female, Male Male | 68 Participants | 137 Participants | 69 Participants |
| Weight (kilograms) | 90.8 kilograms STANDARD_DEVIATION 21.5 | 87.7 kilograms STANDARD_DEVIATION 19.3 | 84.6 kilograms STANDARD_DEVIATION 16.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 101 |
| other Total, other adverse events | 4 / 101 | 2 / 101 |
| serious Total, serious adverse events | 2 / 101 | 9 / 101 |
Outcome results
Primary
6-minute Walking Distance (Meters)
Mean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization.
Time frame: 12 weeks after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | 6-minute Walking Distance (Meters) | 506.1 meters | Standard Deviation 113.9 |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | 6-minute Walking Distance (Meters) | 489.8 meters | Standard Deviation 104 |
Comparison: Significance testing: Generalized regression modelp-value: 0.04t-test, 1 sided
Secondary
Blood Pressure Control
Blood pressure control (Cardiovascular secondary health metric component). Ideal (SBP \<130 mmHg and DBP \<90 mmHg). Intermediate (SBP 130-139 mmHg or DBP 80-89 mmHg). Poor (SBP ≥140 mmHg or DBP ≥90 mmHg).
Time frame: 12 weeks after randomization
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Blood Pressure Control | Ideal | 59 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Blood Pressure Control | Intermediate | 34 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Blood Pressure Control | Poor | 8 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Blood Pressure Control | Ideal | 65 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Blood Pressure Control | Intermediate | 27 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Blood Pressure Control | Poor | 9 Participants |
p-value: 0.6Chi-squared
Secondary
Blood Pressure (mmHg)
Systolic blood pressure and Diastolic blood pressure
Time frame: 12 weeks after randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Blood Pressure (mmHg) | Systolic blood pressure | 122.7 mmHg | Standard Deviation 13.8 |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Blood Pressure (mmHg) | Diastolic blood pressure | 70.5 mmHg | Standard Deviation 11.5 |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Blood Pressure (mmHg) | Systolic blood pressure | 121.0 mmHg | Standard Deviation 13.6 |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Blood Pressure (mmHg) | Diastolic blood pressure | 68.6 mmHg | Standard Deviation 10.8 |
Comparison: For systolic blood pressurep-value: 0.4t-test, 2 sided
Comparison: For diastolic blood pressurep-value: 0.25t-test, 2 sided
Secondary
Body Mass Index (kg/m^2)
BMI = weight (kg) / height in meters squared (m\^2). Weight and height measured by study staff at study visit.
Time frame: 12 weeks after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Body Mass Index (kg/m^2) | 30.2 kg/m^2 | Standard Deviation 6.7 |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Body Mass Index (kg/m^2) | 28.7 kg/m^2 | Standard Deviation 7.4 |
p-value: 0.19t-test, 2 sided
Secondary
Cardiac Rehabilitation Engagement
Cardiac rehabilitation engagement as measured by number of participants who attended the sessions per category. Grouped by Healthcare Effectiveness Data and Information Set (HEDIS) categories: Initiation (0-12 sessions attended), Engagement 1 (13-24 sessions attended), Engagement 2 (25-36 sessions attended).
Time frame: 12 weeks after randomization
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Cardiac Rehabilitation Engagement | Initiation (0-12 sessions attended) | 37 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Cardiac Rehabilitation Engagement | Engagement 1 (13-24 sessions attended) | 20 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Cardiac Rehabilitation Engagement | Engagement 2 (25-36 sessions attended) | 44 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Cardiac Rehabilitation Engagement | Initiation (0-12 sessions attended) | 31 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Cardiac Rehabilitation Engagement | Engagement 1 (13-24 sessions attended) | 29 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Cardiac Rehabilitation Engagement | Engagement 2 (25-36 sessions attended) | 41 Participants |
p-value: 0.35Chi-squared
Secondary
Cholesterol (LDL-C) Control
Cholesterol (LDL-C) control (Cardiovascular secondary health metric component). Ideal (LDL-C \<70mg/dL). Intermediate (LDL-C 70-99 mg/dL). Poor (LDL-C ≥100mg/dL)
Time frame: 12 weeks after randomization
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Cholesterol (LDL-C) Control | Ideal | 62 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Cholesterol (LDL-C) Control | Intermediate | 23 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Cholesterol (LDL-C) Control | Poor | 16 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Cholesterol (LDL-C) Control | Ideal | 52 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Cholesterol (LDL-C) Control | Intermediate | 30 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Cholesterol (LDL-C) Control | Poor | 19 Participants |
p-value: 0.57Chi-squared
Secondary
Composite Cardiovascular Health Metric for Secondary Prevention
The cardiovascular health metric for secondary prevention (adapted from American Heart Association's Life Simple 7). The score ranges from 0 to 14 with higher score indicating better cardiovascular health.
Time frame: 12 weeks after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Composite Cardiovascular Health Metric for Secondary Prevention | 9.6 Score on a scale | Standard Deviation 1.7 |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Composite Cardiovascular Health Metric for Secondary Prevention | 9.5 Score on a scale | Standard Deviation 1.7 |
p-value: 0.58t-test, 2 sided
Secondary
Diabetes Control
Diabetes (HbA1c) control (Cardiovascular secondary health metric component). Ideal (HbA1c \<7% for diabetic, \<5.7% for non-diabetic). Intermediate (HbA1c 7.0-7.9% for diabetic, 5.0-5.9% for non-diabetic). Poor (HbA1c ≥8% for diabetic, ≥6.5% for non-diabetic).
Time frame: 12 weeks after randomization
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Diabetes Control | Ideal | 66 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Diabetes Control | Intermediate | 32 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Diabetes Control | Poor | 3 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Diabetes Control | Ideal | 55 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Diabetes Control | Intermediate | 40 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Diabetes Control | Poor | 6 Participants |
p-value: 0.28Chi-squared
Secondary
Diet Categories
Diet categories (Cardiovascular secondary health metric component). Ideal (Rate Your Plate score 64-81). Intermediate (Rate Your Plate score 46-63). Poor (Rate Your Plate score 27-45).
Time frame: 12 weeks after randomization
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Diet Categories | Ideal | 62 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Diet Categories | Intermediate | 39 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Diet Categories | Poor | 0 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Diet Categories | Ideal | 57 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Diet Categories | Intermediate | 44 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Diet Categories | Poor | 0 Participants |
p-value: 0.6Chi-squared
Secondary
Glycosylated Hemoglobin (HbA1c)
Glycosylated hemoglobin (HbA1c) level (%) measured through blood sample drawn at 12 week follow up visit
Time frame: 12 weeks after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Glycosylated Hemoglobin (HbA1c) | 5.8 percentage of glycated hemoglobin | Standard Deviation 0.7 |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Glycosylated Hemoglobin (HbA1c) | 5.9 percentage of glycated hemoglobin | Standard Deviation 0.8 |
p-value: 0.39t-test, 2 sided
Secondary
Low Density Lipoprotein - Cholesterol (LDL-C)
LDL cholesterol level (in mg/dl) measured through blood sample drawn at 12 week follow up visit
Time frame: 12 weeks after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Low Density Lipoprotein - Cholesterol (LDL-C) | 65.6 mg/dL | Standard Deviation 33.1 |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Low Density Lipoprotein - Cholesterol (LDL-C) | 71.4 mg/dL | Standard Deviation 31.4 |
p-value: 0.27t-test, 2 sided
Secondary
Physical Activity Categories
Physical activity categories (Cardiovascular secondary health metric component). Ideal (≥150 min/wk moderate physical activity, ≥75 min/wk vigorous physical activity). Intermediate (1-149 min/wk moderate physical activity, 1-74 min/wk vigorous physical activity). Poor (No regular exercise).
Time frame: 12 weeks after randomization
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Physical Activity Categories | Ideal | 72 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Physical Activity Categories | Intermediate | 29 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Physical Activity Categories | Poor | 0 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Physical Activity Categories | Ideal | 81 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Physical Activity Categories | Intermediate | 18 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Physical Activity Categories | Poor | 2 Participants |
p-value: 0.19Chi-squared
Secondary
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10: 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.
Time frame: 12 weeks after randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 | Global physical health score | 50.4 t-score | Standard Deviation 7.4 |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 | Global mental health score | 52.0 t-score | Standard Deviation 8.4 |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 | Global physical health score | 52.0 t-score | Standard Deviation 6.9 |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 | Global mental health score | 52.1 t-score | Standard Deviation 7.4 |
Comparison: For: Global physical health scorep-value: 0.16t-test, 2 sided
Comparison: For: Global mental health scorep-value: 0.71t-test, 2 sided
Secondary
Tobacco Use
Tobacco use categories (Cardiovascular secondary health metric component). Ideal (never). Intermediate (Former smoker). Poor (Recent/Current smoker).
Time frame: 12 weeks after randomization
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Tobacco Use | Ideal/Intermediate (Never/Former smoker) | 99 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Tobacco Use | Poor (Recent/Current smoker) | 2 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Tobacco Use | Ideal/Intermediate (Never/Former smoker) | 89 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Tobacco Use | Poor (Recent/Current smoker) | 12 Participants |
p-value: 1Chi-squared
Secondary
Weight (BMI) Categories
Weight (BMI) categories (Cardiovascular secondary health metric component). Ideal (BMI \<25 kg/m\^2). Intermediate (BMI 25-29 kg/m\^2). Poor (BMI ≥ 30 kg/m\^2).
Time frame: 12 weeks after randomization
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Weight (BMI) Categories | Ideal | 25 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Weight (BMI) Categories | Intermediate | 23 Participants |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Weight (BMI) Categories | Poor | 53 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Weight (BMI) Categories | Ideal | 29 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Weight (BMI) Categories | Intermediate | 35 Participants |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Weight (BMI) Categories | Poor | 37 Participants |
p-value: 0.09Chi-squared
Other Pre-specified
Anxiety as Assessed by the Generalized Anxiety Disorder 7
The difference in anxiety level as measured by Generalized Anxiety Disorder 7 (GAD 7): 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.
Time frame: 12 weeks after randomization
Population: Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Anxiety as Assessed by the Generalized Anxiety Disorder 7 | 1 score on a scale |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Anxiety as Assessed by the Generalized Anxiety Disorder 7 | 1 score on a scale |
Other Pre-specified
Depression as Assessed by the Patient Health Questionnaire 8
The difference in depressive symptoms as measured by Patient Health Questionnaire 8 (PHQ 8): The 8 item questionnaire administered at 12 weeks with the following scoring system: Score range 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression. Note, as an exploratory outcome, only a subgroup of participants responded to this survey request.
Time frame: 12 weeks after randomization
Population: Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Depression as Assessed by the Patient Health Questionnaire 8 | 2 score on a scale |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Depression as Assessed by the Patient Health Questionnaire 8 | 2 score on a scale |
Other Pre-specified
Health Literacy as Assessed by the (e) Health Literacy Scale (eHEALS)
The difference in Health Literacy as measured by The (e) Health Literacy Scale (eHEALS): 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.
Time frame: 12 weeks after randomization
Population: Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Health Literacy as Assessed by the (e) Health Literacy Scale (eHEALS) | 31.7 Score on a scale | Standard Deviation 5.5 |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Health Literacy as Assessed by the (e) Health Literacy Scale (eHEALS) | 32.3 Score on a scale | Standard Deviation 5.1 |
Other Pre-specified
Patient Activation as Assessed by the Patient Activation Measure 10
The difference in patient activation as measured by Patient Activation Measure 10 (PAM 10): The 10-item five-point Likert scale for assessing patient activation at 12 weeks follow up, indicating whether the patient possesses the necessary knowledge, skills, and confidence needed for self-care. The total score reference range is from 0 to 100, where higher scores indicate greater patient activation and ability for self-care.
Time frame: 12 weeks after randomization
Population: Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Patient Activation as Assessed by the Patient Activation Measure 10 | 33.7 Score on a scale | Standard Deviation 4.7 |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Patient Activation as Assessed by the Patient Activation Measure 10 | 35.1 Score on a scale | Standard Deviation 3.4 |
Other Pre-specified
Stress as Assessed by the Perceived Stress Scale-10
The difference in stress level as measured by Perceived Stress Scale (PSS -10): 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.
Time frame: 12 weeks after randomization
Population: Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Stress as Assessed by the Perceived Stress Scale-10 | 11.5 Score on a scale | Standard Deviation 6.6 |
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Stress as Assessed by the Perceived Stress Scale-10 | 11.0 Score on a scale | Standard Deviation 6.9 |
Other Pre-specified
User Engagement as Assessed by the Number of App Interactions (Intervention Group Only)
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).
Time frame: 12 weeks after randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | User Engagement as Assessed by the Number of App Interactions (Intervention Group Only) | App interaction for heart rate event | 11821.6 app interactions | Standard Deviation 17364.7 |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | User Engagement as Assessed by the Number of App Interactions (Intervention Group Only) | App interaction for blood pressure event | 16.9 app interactions | Standard Deviation 19 |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | User Engagement as Assessed by the Number of App Interactions (Intervention Group Only) | App interaction for exercise completion event | 34.9 app interactions | Standard Deviation 38.7 |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | User Engagement as Assessed by the Number of App Interactions (Intervention Group Only) | App interaction for medication taken event | 296.5 app interactions | Standard Deviation 264.7 |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | User Engagement as Assessed by the Number of App Interactions (Intervention Group Only) | App interaction for weight check event | 51.7 app interactions | Standard Deviation 35.9 |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | User Engagement as Assessed by the Number of App Interactions (Intervention Group Only) | App interaction for mood check event | 53.7 app interactions | Standard Deviation 35.6 |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | User Engagement as Assessed by the Number of App Interactions (Intervention Group Only) | App interaction for step count check event | 125.7 app interactions | Standard Deviation 168.9 |
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | User Engagement as Assessed by the Number of App Interactions (Intervention Group Only) | App interaction for education event | 17.7 app interactions | Standard Deviation 8.4 |