The Improving ATTENDance to Cardiac Rehabilitation Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03646760

Acronym

iATTEND

Enrollment

282

Registered

2018-08-24

Start date

2019-03-01

Completion date

2023-12-31

Last updated

2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris, Cardiac Event, Coronary Artery Disease, Heart Failure, Heart Valve Diseases, Myocardial Infarction

Brief summary

The benefits of cardiac rehabilitation are well known. However, despite center based cardiac rehabilitation (CBCR) representing guideline-based care for patients with cardiovascular disease, most patients do not complete the maximum number of sessions allowed by third party insurance payers. As such, many patients may not be receiving the full clinical benefit ascribed to CR. This study will assess the efficacy of an innovative approach to CR delivery on attendance by combining both center-based and remote- or home-based CR sessions. The intervention group combines center-based CR and remote-/home-based CR and is tailored to the individual needs of each patient, accomplished with the assistance of an easy-to-access telecommunications methodology (telemedicine)

Interventions

BEHAVIORALHYCR

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.

BEHAVIORALCBCR

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Has agreed to participate in CR and has experienced a cardiac event (myocardial infraction, coronary revascularization, heart valve surgery, or cardiac transplant in the past 6 months; diagnosed with chronic, stable AHA/ACC stage B or C heart failure or Canadian class 0-2 stable angina pectoris) 2. Lives in or plans to remain in the greater Detroit, MI area for the next year 3. Age 18-85 years of age 4. Agrees to attend at least one CBCR session 5. Agrees to scheduling at least 2, up to 3, CR sessions (either CBCR or HYCR)/wk 6. Has demonstrated to research staff their ability to access and connect to the internet via smart phone or tablet and already has access to satisfactory home- or community-based exercise equipment

Exclusion criteria

1. Received a left ventricular assist device, receiving continuous inotropic support (e.g., milrinone), or undergoing hemodialysis 2. Angina at rest or with a low functional capacity (\< 2 METs) 3. Advanced cancer, advanced risk for falling, limiting cognitive impairment, or other advanced disorder that limits participation in CR 1. Advanced risk for falling will be assessed by 5X sit-to-stand test, with a cut-off score of \>15 seconds 2. Cognitive assessment will be completed using the Mini-Cog instrument, with a cut-off score \< 3 used to exclude potential subjects. 4. Severe arrhythmia unless adequately treated (e.g., implantable cardiac defibrillator) 5. Pregnant or plan to become pregnant in the next year. 6. Major cardiovascular procedure or hospitalization planned in the next 6 months 7. Less than 12 month life expectancy 8. Participation in another clinical trial that interferes with iATTEND participation, follow-up, data collection, exercise capacity or quality of life.

Design outcomes

Primary

Measure	Time frame	Description
Number of CR Sessions Completed Within 6 Months in Patients Randomized to HYCR vs. Patients Randomized to Traditional CBCR (Usual Care).	Baseline to 6 months	—
Percentage of Patients Completing 36 CR Sessions Within 6 Months Among Patients Randomized to the HYCR Program vs. Patients Randomized to the CBCR Program.	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.

Secondary

Measure	Time frame	Description
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.	Baseline to 6 months	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).
Improvement in Exercise Capacity, as Measured by Peak Oxygen Uptake (VO2), in Patients Randomized to HYCR vs Patients Randomized to CBCR.	Baseline to 6 months	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).
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.	Baseline to 6 months	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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	142
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).	140
Total	282

Baseline characteristics

Characteristic	Hybrid Cardiac Rehabilitation (HYCR)	Center Based Cardiac Rehabilitation (CBCR)	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	56 Participants	72 Participants	128 Participants
Age, Categorical Between 18 and 65 years	86 Participants	68 Participants	154 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) Asian	3 Participants	4 Participants	7 Participants
Race (NIH/OMB) Black or African American	76 Participants	76 Participants	152 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	62 Participants	59 Participants	121 Participants
Sex: Female, Male Female	45 Participants	46 Participants	91 Participants
Sex: Female, Male Male	97 Participants	94 Participants	191 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 142	3 / 140
other Total, other adverse events	8 / 142	3 / 140
serious Total, serious adverse events	1 / 142	0 / 140