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Completed

NCT Number: NCT03646760

The Improving ATTENDance to Cardiac Rehabilitation Trial

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)

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Key information

Conditions

Myocardial Infarction Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiac Event Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Heart Failure Heart Valve Diseases Infarction Ischemia Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

HYCR

Behavioral

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

Behavioral

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).

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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 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).

  2. 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 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).

  3. 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

    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).

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: iATTEND

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2018
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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