Myocardial InfarctioniATTENDNCT03646760
The Improving ATTENDance to Cardiac Rehabilitation Trial
A study testing HYCR and CBCR in people with Myocardial Infarction and Heart Failure, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction, Heart Failure, Heart Valve Diseases
- What is being tested?
- HYCR and CBCR
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Conditions
- Myocardial Infarction, Heart Failure, Heart Valve Diseases, Cardiac Event, Angina Pectoris, Coronary Artery Disease
- Being tested
- HYCR, CBCR
- Medical subject headings
- Myocardial Infarction, Heart Failure, Heart Valve Diseases, Cardiovascular Diseases, Angina Pectoris, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYCRBehavioural
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.
CBCRBehavioural
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 group | Role | What they receive |
|---|---|---|
| Hybrid Cardiac Rehabilitation (HYCR) | Experimental | Not described Receives: Behavioral: HYCR |
| Center Based cardiac Rehabilitation (CBCR) | Active comparator | Not described Receives: Behavioral: CBCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CR Sessions Completed Within 6 Months in Patients Randomized to HYCR vs. Patients Randomized to Traditional CBCR (Usual Care).
Measured: 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.
Measured: 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.
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).
Measured: 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.
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).
Measured: 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.
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).
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Mar 2019
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Steven J. Keteyian, Henry Ford Health System
- Investigators
- Steven Keteyian, PhD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646760
- Sponsor's protocol ID
- HFHS iATTEND
- Other IDs
- R33HL143099
- Acronym
- iATTEND
- Status last verified
- Jul 2025
- First submitted
- 14 Aug 2018
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38670326Keteyian 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.
PubMed 33351540
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improving ATTENDance to Cardiac Rehabilitation Trial
- ClinicalTrials.gov ID
- NCT03646760
- Acronym / sponsor ID
- iATTEND / HFHS iATTEND
- Conditions
- Myocardial Infarction, Heart Failure, Heart Valve Diseases, Cardiac Event, Angina Pectoris, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Cardiac Rehabilitation (HYCR) | Experimental | Behavioral: HYCR |
| Center Based cardiac Rehabilitation (CBCR) | Active comparator | Behavioral: CBCR |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- Severe arrhythmia unless adequately treated (e.g., implantable cardiac defibrillator)
- Pregnant or plan to become pregnant in the next year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HYCRThis 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. | Behavioural | Hybrid Cardiac Rehabilitation (HYCR) |
| CBCRThis 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). | Behavioural | Center Based cardiac Rehabilitation (CBCR) |
Primary outcome
Number of CR Sessions Completed Within 6 Months in Patients Randomized to HYCR vs. Patients Randomized to Traditional CBCR (Usual Care).
Time frame: 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.
Time frame: 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.
3 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38670326Keteyian 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.
- Derived from this study: PubMed 33351540Keteyian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Keteyian, PhD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYCR and CBCR in people with Myocardial Infarction and Heart Failure, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of CR Sessions Completed Within 6 Months in Patients Randomized to HYCR vs. Patients Randomized to Traditional CBCR (Usual Care). (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03646760, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.