The Improving ATTENDance to Cardiac Rehabilitation Trial
NCT ID: NCT03646760
Last Updated: 2025-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
282 participants
INTERVENTIONAL
2019-03-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Interventions
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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.
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).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Henry Ford Health System
OTHER
Responsible Party
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Steven J. Keteyian
Principal Investigator
Principal Investigators
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Steven Keteyian, PhD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Locations
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Henry Ford Health System
Detroit, Michigan, United States
Countries
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References
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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.
Keteyian 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HFHS iATTEND
Identifier Type: -
Identifier Source: org_study_id
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