Trial Outcomes & Findings for Impact of a Corrie Cardiac Rehabilitation Program (NCT NCT05238103)
NCT ID: NCT05238103
Last Updated: 2025-12-05
Results Overview
Mean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
259 participants
Primary outcome timeframe
12 weeks after randomization
Results posted on
2025-12-05
Participant Flow
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).
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.
Participant milestones
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
101
|
|
Overall Study
COMPLETED
|
85
|
77
|
|
Overall Study
NOT COMPLETED
|
16
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of a Corrie Cardiac Rehabilitation Program
Baseline characteristics by cohort
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 Years
STANDARD_DEVIATION 12.4 • n=37 Participants
|
63.3 Years
STANDARD_DEVIATION 11.5 • n=37 Participants
|
63.9 Years
STANDARD_DEVIATION 12.0 • n=74 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=37 Participants
|
32 Participants
n=37 Participants
|
65 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=37 Participants
|
69 Participants
n=37 Participants
|
137 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
White
|
83 Participants
n=37 Participants
|
82 Participants
n=37 Participants
|
165 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
African American
|
8 Participants
n=37 Participants
|
10 Participants
n=37 Participants
|
18 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=37 Participants
|
5 Participants
n=37 Participants
|
11 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
2 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
5 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Declined to answer
|
1 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=74 Participants
|
|
Cardiac Rehabilitation Indication (Disease Category + Treatment Modality)
AMI (Medically treated)
|
0 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
1 Participants
n=74 Participants
|
|
Cardiac Rehabilitation Indication (Disease Category + Treatment Modality)
AMI (Treated with PCI)
|
15 Participants
n=37 Participants
|
18 Participants
n=37 Participants
|
33 Participants
n=74 Participants
|
|
Cardiac Rehabilitation Indication (Disease Category + Treatment Modality)
AMI (Treated with CABG)
|
2 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
3 Participants
n=74 Participants
|
|
Cardiac Rehabilitation Indication (Disease Category + Treatment Modality)
CAD without AMI (Treated with PCI)
|
29 Participants
n=37 Participants
|
30 Participants
n=37 Participants
|
59 Participants
n=74 Participants
|
|
Cardiac Rehabilitation Indication (Disease Category + Treatment Modality)
CAD without AMI (Treated with CABG)
|
15 Participants
n=37 Participants
|
11 Participants
n=37 Participants
|
26 Participants
n=74 Participants
|
|
Cardiac Rehabilitation Indication (Disease Category + Treatment Modality)
VHD (Treated with TAVR)
|
10 Participants
n=37 Participants
|
3 Participants
n=37 Participants
|
13 Participants
n=74 Participants
|
|
Cardiac Rehabilitation Indication (Disease Category + Treatment Modality)
VHD (Treated with Heart valve surgery)
|
27 Participants
n=37 Participants
|
35 Participants
n=37 Participants
|
62 Participants
n=74 Participants
|
|
Cardiac Rehabilitation Indication (Disease Category + Treatment Modality)
Combined CABG + Heart valve surgery
|
3 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
5 Participants
n=74 Participants
|
|
Clinical History
Hypertension
|
76 Participants
n=37 Participants
|
77 Participants
n=37 Participants
|
153 Participants
n=74 Participants
|
|
Clinical History
Hyperlipidemia
|
83 Participants
n=37 Participants
|
88 Participants
n=37 Participants
|
171 Participants
n=74 Participants
|
|
Clinical History
Diabetes mellitus
|
25 Participants
n=37 Participants
|
19 Participants
n=37 Participants
|
44 Participants
n=74 Participants
|
|
Clinical History
Tobacco use
|
2 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
4 Participants
n=74 Participants
|
|
Clinical History
Coronary artery disease
|
75 Participants
n=37 Participants
|
80 Participants
n=37 Participants
|
155 Participants
n=74 Participants
|
|
Clinical History
Myocardial infarction
|
30 Participants
n=37 Participants
|
32 Participants
n=37 Participants
|
62 Participants
n=74 Participants
|
|
Clinical History
Atrial fibrillation
|
38 Participants
n=37 Participants
|
28 Participants
n=37 Participants
|
66 Participants
n=74 Participants
|
|
Clinical History
Valvular heart disease
|
43 Participants
n=37 Participants
|
42 Participants
n=37 Participants
|
85 Participants
n=74 Participants
|
|
Clinical History
Heart failure
|
15 Participants
n=37 Participants
|
18 Participants
n=37 Participants
|
33 Participants
n=74 Participants
|
|
Cardiac Rehabilitation Indication (Disease Category)
AMI
|
17 Participants
n=37 Participants
|
20 Participants
n=37 Participants
|
37 Participants
n=74 Participants
|
|
Cardiac Rehabilitation Indication (Disease Category)
CAD without AMI
|
44 Participants
n=37 Participants
|
41 Participants
n=37 Participants
|
85 Participants
n=74 Participants
|
|
Cardiac Rehabilitation Indication (Disease Category)
VHD
|
37 Participants
n=37 Participants
|
38 Participants
n=37 Participants
|
75 Participants
n=74 Participants
|
|
Cardiac Rehabilitation Indication (Disease Category)
CAD with VHD
|
3 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
5 Participants
n=74 Participants
|
|
Blood Pressure (mmHg)
Systolic blood pressure (mmHg)
|
124.3 mmHg
STANDARD_DEVIATION 16.1 • n=37 Participants
|
126.8 mmHg
STANDARD_DEVIATION 17.3 • n=37 Participants
|
125.3 mmHg
STANDARD_DEVIATION 16.7 • n=74 Participants
|
|
Blood Pressure (mmHg)
Diastolic blood pressure (mmHg)
|
70.7 mmHg
STANDARD_DEVIATION 9.8 • n=37 Participants
|
70.9 mmHg
STANDARD_DEVIATION 10.5 • n=37 Participants
|
70.8 mmHg
STANDARD_DEVIATION 10.1 • n=74 Participants
|
|
Heart Rate (beats per minute)
|
74.2 beats per minute
STANDARD_DEVIATION 12.7 • n=37 Participants
|
73.1 beats per minute
STANDARD_DEVIATION 12.6 • n=37 Participants
|
73.6 beats per minute
STANDARD_DEVIATION 12.6 • n=74 Participants
|
|
Weight (kilograms)
|
90.8 kilograms
STANDARD_DEVIATION 21.5 • n=37 Participants
|
84.6 kilograms
STANDARD_DEVIATION 16.2 • n=37 Participants
|
87.7 kilograms
STANDARD_DEVIATION 19.3 • n=74 Participants
|
|
Body Mass Index (kg/m^2)
|
29.7 kg/m^2
STANDARD_DEVIATION 6.0 • n=37 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 5.3 • n=37 Participants
|
29.1 kg/m^2
STANDARD_DEVIATION 5.7 • n=74 Participants
|
|
Left Ventricular ejection fraction (LVEF)
|
58.2 Percentage of LVEF
STANDARD_DEVIATION 7.7 • n=37 Participants
|
59.2 Percentage of LVEF
STANDARD_DEVIATION 6.7 • n=37 Participants
|
58.7 Percentage of LVEF
STANDARD_DEVIATION 7.2 • n=74 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after randomizationMean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization.
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
6-minute Walking Distance (Meters)
|
506.1 meters
Standard Deviation 113.9
|
489.8 meters
Standard Deviation 104.0
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationThe 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.
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Composite Cardiovascular Health Metric for Secondary Prevention
|
9.6 Score on a scale
Standard Deviation 1.7
|
9.5 Score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationSystolic blood pressure and Diastolic blood pressure
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Blood Pressure (mmHg)
Systolic blood pressure
|
122.7 mmHg
Standard Deviation 13.8
|
121.0 mmHg
Standard Deviation 13.6
|
|
Blood Pressure (mmHg)
Diastolic blood pressure
|
70.5 mmHg
Standard Deviation 11.5
|
68.6 mmHg
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationLDL cholesterol level (in mg/dl) measured through blood sample drawn at 12 week follow up visit
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Low Density Lipoprotein - Cholesterol (LDL-C)
|
65.6 mg/dL
Standard Deviation 33.1
|
71.4 mg/dL
Standard Deviation 31.4
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationGlycosylated hemoglobin (HbA1c) level (%) measured through blood sample drawn at 12 week follow up visit
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Glycosylated Hemoglobin (HbA1c)
|
5.8 percentage of glycated hemoglobin
Standard Deviation 0.7
|
5.9 percentage of glycated hemoglobin
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationBMI = weight (kg) / height in meters squared (m\^2). Weight and height measured by study staff at study visit.
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Body Mass Index (kg/m^2)
|
30.2 kg/m^2
Standard Deviation 6.7
|
28.7 kg/m^2
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationPatient-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.
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
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
|
52.0 t-score
Standard Deviation 6.9
|
|
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
|
52.1 t-score
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationBlood 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).
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Blood Pressure Control
Ideal
|
59 Participants
|
65 Participants
|
|
Blood Pressure Control
Intermediate
|
34 Participants
|
27 Participants
|
|
Blood Pressure Control
Poor
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationCholesterol (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)
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Cholesterol (LDL-C) Control
Ideal
|
62 Participants
|
52 Participants
|
|
Cholesterol (LDL-C) Control
Intermediate
|
23 Participants
|
30 Participants
|
|
Cholesterol (LDL-C) Control
Poor
|
16 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationDiabetes (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).
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Diabetes Control
Poor
|
3 Participants
|
6 Participants
|
|
Diabetes Control
Ideal
|
66 Participants
|
55 Participants
|
|
Diabetes Control
Intermediate
|
32 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationWeight (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).
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Weight (BMI) Categories
Ideal
|
25 Participants
|
29 Participants
|
|
Weight (BMI) Categories
Intermediate
|
23 Participants
|
35 Participants
|
|
Weight (BMI) Categories
Poor
|
53 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationPhysical 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).
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Physical Activity Categories
Ideal
|
72 Participants
|
81 Participants
|
|
Physical Activity Categories
Intermediate
|
29 Participants
|
18 Participants
|
|
Physical Activity Categories
Poor
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationDiet 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).
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Diet Categories
Ideal
|
62 Participants
|
57 Participants
|
|
Diet Categories
Intermediate
|
39 Participants
|
44 Participants
|
|
Diet Categories
Poor
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationTobacco use categories (Cardiovascular secondary health metric component). Ideal (never). Intermediate (Former smoker). Poor (Recent/Current smoker).
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Tobacco Use
Ideal/Intermediate (Never/Former smoker)
|
99 Participants
|
89 Participants
|
|
Tobacco Use
Poor (Recent/Current smoker)
|
2 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after randomizationCardiac 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).
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Cardiac Rehabilitation Engagement
Initiation (0-12 sessions attended)
|
37 Participants
|
31 Participants
|
|
Cardiac Rehabilitation Engagement
Engagement 1 (13-24 sessions attended)
|
20 Participants
|
29 Participants
|
|
Cardiac Rehabilitation Engagement
Engagement 2 (25-36 sessions attended)
|
44 Participants
|
41 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks after randomizationPopulation: Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.
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.
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=79 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=66 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Depression as Assessed by the Patient Health Questionnaire 8
|
2 score on a scale
Interval 0.0 to 5.0
|
2 score on a scale
Interval 0.0 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks after randomizationPopulation: Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.
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.
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=79 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=66 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Anxiety as Assessed by the Generalized Anxiety Disorder 7
|
1 score on a scale
Interval 0.0 to 4.0
|
1 score on a scale
Interval 0.0 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks after randomizationPopulation: Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.
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.
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=79 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=66 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Stress as Assessed by the Perceived Stress Scale-10
|
11.5 Score on a scale
Standard Deviation 6.6
|
11.0 Score on a scale
Standard Deviation 6.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks after randomizationPopulation: Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.
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.
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=80 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=69 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Health Literacy as Assessed by the (e) Health Literacy Scale (eHEALS)
|
31.7 Score on a scale
Standard Deviation 5.5
|
32.3 Score on a scale
Standard Deviation 5.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks after randomizationPopulation: Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.
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.
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=80 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=69 Participants
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Patient Activation as Assessed by the Patient Activation Measure 10
|
33.7 Score on a scale
Standard Deviation 4.7
|
35.1 Score on a scale
Standard Deviation 3.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks after randomizationNumber 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).
Outcome measures
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 Participants
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 19.0
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
Adverse Events
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
Serious events: 9 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 participants at risk
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 participants at risk
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Cardiac disorders
Acute decompensated heart failure
|
0.99%
1/101 • Number of events 1 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
0.00%
0/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
0.99%
1/101 • Number of events 1 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
0.00%
0/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
|
Cardiac disorders
ST-elevation myocardial infarction (STEMI) due to bypass graft occlusion
|
0.00%
0/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
0.99%
1/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
0.99%
1/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
|
Nervous system disorders
Syncope
|
0.00%
0/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
0.99%
1/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
|
Musculoskeletal and connective tissue disorders
Chest pain (non-cardiac)
|
0.00%
0/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
2.0%
2/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
2.0%
2/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
|
Infections and infestations
Infection
|
0.00%
0/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
2.0%
2/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
Other adverse events
| Measure |
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)
n=101 participants at risk
Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
|
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)
n=101 participants at risk
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Symptoms during 6 minute walk test
|
2.0%
2/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
0.99%
1/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
|
Musculoskeletal and connective tissue disorders
Chest pain at home (non-cardiac)
|
0.99%
1/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
0.00%
0/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
|
Musculoskeletal and connective tissue disorders
Pain from wearable device
|
0.99%
1/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
0.00%
0/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
|
Product Issues
Delayed blood sample processing
|
0.00%
0/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
0.99%
1/101 • From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place