The Improving ATTENDance to Cardiac Rehabilitation Trial
iATTEND
2 other identifiers
interventional
282
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2018
CompletedFirst Posted
Study publicly available on registry
August 24, 2018
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedResults Posted
Study results publicly available
July 29, 2025
CompletedJuly 29, 2025
July 1, 2025
4.8 years
August 14, 2018
April 15, 2025
July 28, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Baseline to 6 months
Secondary Outcomes (3)
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, as Measured by Peak Oxygen Uptake (VO2), in Patients Randomized to HYCR vs Patients Randomized to CBCR.
Baseline to 6 months
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
Study Arms (2)
Hybrid Cardiac Rehabilitation (HYCR)
EXPERIMENTALCenter Based cardiac Rehabilitation (CBCR)
ACTIVE COMPARATORInterventions
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.
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).
Eligibility Criteria
You may qualify if:
- 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)
- Lives in or plans to remain in the greater Detroit, MI area for the next year
- Age 18-85 years of age
- Agrees to attend at least one CBCR session
- Agrees to scheduling at least 2, up to 3, CR sessions (either CBCR or HYCR)/wk
- 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
You may not qualify if:
- Received a left ventricular assist device, receiving continuous inotropic support (e.g., milrinone), or undergoing hemodialysis
- Angina at rest or with a low functional capacity (\< 2 METs)
- Advanced cancer, advanced risk for falling, limiting cognitive impairment, or other advanced disorder that limits participation in CR
- Advanced risk for falling will be assessed by 5X sit-to-stand test, with a cut-off score of \>15 seconds
- Cognitive assessment will be completed using the Mini-Cog instrument, with a cut-off score \< 3 used to exclude potential subjects.
- Severe arrhythmia unless adequately treated (e.g., implantable cardiac defibrillator)
- Pregnant or plan to become pregnant in the next year.
- Major cardiovascular procedure or hospitalization planned in the next 6 months
- Less than 12 month life expectancy
- Participation in another clinical trial that interferes with iATTEND participation, follow-up, data collection, exercise capacity or quality of life.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henry Ford Health System
Detroit, Michigan, 48202, United States
Related Publications (2)
Keteyian SJ, Grimshaw C, Ehrman JK, Kerrigan DJ, Abdul-Nour K, Lanfear DE, Brawner CA. The iATTEND Trial: A Trial Comparing Hybrid Versus Standard Cardiac Rehabilitation. Am J Cardiol. 2024 Jun 15;221:94-101. doi: 10.1016/j.amjcard.2024.04.034. Epub 2024 Apr 25.
PMID: 38670326DERIVEDKeteyian SJ, Grimshaw C, Brawner CA, Kerrigan DJ, Reasons L, Berry R, Peterson EL, Ehrman JK. A Comparison of Exercise Intensity in Hybrid Versus Standard Phase Two Cardiac Rehabilitation. J Cardiopulm Rehabil Prev. 2021 Jan 1;41(1):19-22. doi: 10.1097/HCR.0000000000000569.
PMID: 33351540DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Steven Keteyian, PhD
- Organization
- Henry Ford Health
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Keteyian, PhD
Henry Ford Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 14, 2018
First Posted
August 24, 2018
Study Start
March 1, 2019
Primary Completion
December 30, 2023
Study Completion
December 31, 2023
Last Updated
July 29, 2025
Results First Posted
July 29, 2025
Record last verified: 2025-07