Trial Outcomes & Findings for The Improving ATTENDance to Cardiac Rehabilitation Trial (NCT NCT03646760)

NCT ID: NCT03646760

Last Updated: 2025-07-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 282 participants
• Primary outcome timeframe: Baseline to 6 months
• Results posted on: 2025-07-29

Participant Flow

Participant milestones

Measure	Hybrid Cardiac Rehabilitation (HYCR) HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject's personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF's that are free to access from the Health System's web site.	Center Based Cardiac Rehabilitation (CBCR) CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).
Overall Study STARTED	142	140
Overall Study COMPLETED	81	78
Overall Study NOT COMPLETED	61	62

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Improving ATTENDance to Cardiac Rehabilitation Trial

Baseline characteristics by cohort

Measure	Hybrid Cardiac Rehabilitation (HYCR) n=142 Participants HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject's personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF's that are free to access from the Health System's web site.	Center Based Cardiac Rehabilitation (CBCR) n=140 Participants CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).	Total n=282 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=5 Participants	68 Participants n=7 Participants	154 Participants n=5 Participants
Age, Categorical >=65 years	56 Participants n=5 Participants	72 Participants n=7 Participants	128 Participants n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	46 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	94 Participants n=7 Participants	191 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	76 Participants n=5 Participants	76 Participants n=7 Participants	152 Participants n=5 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants	59 Participants n=7 Participants	121 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Outcome measures

Measure	Hybrid Cardiac Rehabilitation (HYCR) n=142 Participants HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject's personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF's that are free to access from the Health System's web site.	Center Based Cardiac Rehabilitation (CBCR) n=140 Participants CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).
Number of CR Sessions Completed Within 6 Months in Patients Randomized to HYCR vs. Patients Randomized to Traditional CBCR (Usual Care).	28.7 Number of cardiac rehab sessions Standard Error 11.8	27.6 Number of cardiac rehab sessions Standard Error 11.8

PRIMARY outcome

Timeframe: Baseline to 6 months

Outcome measure is the percent of people who complete all 36 CR sessions and the mean value reported represents the average percentage for all patients in both study groups.

Outcome measures

Measure	Hybrid Cardiac Rehabilitation (HYCR) n=142 Participants HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject's personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF's that are free to access from the Health System's web site.	Center Based Cardiac Rehabilitation (CBCR) n=140 Participants CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).
Percentage of Patients Completing 36 CR Sessions Within 6 Months Among Patients Randomized to the HYCR Program vs. Patients Randomized to the CBCR Program.	58.5 % of patients completing 36 sessions	50.7 % of patients completing 36 sessions

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Analyses represent complete cases for Center Based Only CR and Hybrid CR

Improvement in exercise capacity was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).

Outcome measures

Measure	Hybrid Cardiac Rehabilitation (HYCR) n=108 Participants HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject's personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF's that are free to access from the Health System's web site.	Center Based Cardiac Rehabilitation (CBCR) n=105 Participants CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).
Improvement in Exercise Capacity, as Measured by Distance Walked During the Six Min Walk (6MW) Test, in Patients Randomized to HYCR vs Patients Randomized to CBCR.	46 Meters Standard Deviation 46	50 Meters Standard Deviation 53

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Analyses represent complete cases for Center Based Only CR and Hybrid CR

Improvement in exercise capacity was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).

Outcome measures

Measure	Hybrid Cardiac Rehabilitation (HYCR) n=94 Participants HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject's personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF's that are free to access from the Health System's web site.	Center Based Cardiac Rehabilitation (CBCR) n=92 Participants CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).
Improvement in Exercise Capacity, as Measured by Peak Oxygen Uptake (VO2), in Patients Randomized to HYCR vs Patients Randomized to CBCR.	2.3 mL/kg/min Standard Deviation 2.8	1.9 mL/kg/min Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Analyses represent complete cases for Center Based Only CR and Hybrid CR

5-point Likert-type scaling, with 1 being more positive and 5 being more negative. Lower scores indicate higher levels of quality of life.

Improvement in qualify of life was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).

Outcome measures

Measure	Hybrid Cardiac Rehabilitation (HYCR) n=108 Participants HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject's personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF's that are free to access from the Health System's web site.	Center Based Cardiac Rehabilitation (CBCR) n=108 Participants CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).
Improvement in Quality of Life (QOL), as Measured by the Total Score for Dartmouth COOP, in Patients Randomized to HYCR vs Patients Randomized to CBCR.	-3.9 units on a scale Standard Deviation 5.0	-3.4 units on a scale Standard Deviation 5.3

Adverse Events

Hybrid Cardiac Rehabilitation (HYCR)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 1 deaths

Center Based Cardiac Rehabilitation (CBCR)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Measure	Hybrid Cardiac Rehabilitation (HYCR) n=142 participants at risk HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject's personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF's that are free to access from the Health System's web site.	Center Based Cardiac Rehabilitation (CBCR) n=140 participants at risk CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).
Vascular disorders Stroke	0.70% 1/142 • Number of events 1 • 9-12 months, from the time patient enrolled into the study until they completed final study visit or 12 months from enrollment whichever came first.	0.00% 0/140 • 9-12 months, from the time patient enrolled into the study until they completed final study visit or 12 months from enrollment whichever came first.

Other adverse events

Measure	Hybrid Cardiac Rehabilitation (HYCR) n=142 participants at risk HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject's personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF's that are free to access from the Health System's web site.	Center Based Cardiac Rehabilitation (CBCR) n=140 participants at risk CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).
Cardiac disorders Unstable Angina	5.6% 8/142 • Number of events 8 • 9-12 months, from the time patient enrolled into the study until they completed final study visit or 12 months from enrollment whichever came first.	2.1% 3/140 • Number of events 3 • 9-12 months, from the time patient enrolled into the study until they completed final study visit or 12 months from enrollment whichever came first.

Additional Information

Steven Keteyian, PhD

Henry Ford Health

Phone: 313-972-1920

Email: sketeyian1@hfhs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place