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The Improving ATTENDance in Cardiac Rehabilitation Trial (iATTEND)

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ClinicalTrials.gov Identifier: NCT03646760
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Steven J. Keteyian, Henry Ford Health System

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)

Condition or disease Intervention/treatment Phase
Myocardial Infarction Heart Failure Heart Valve Diseases Cardiac Event Angina Pectoris Coronary Artery Disease Behavioral: HYCR Behavioral: CBCR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Improving ATTENDance in Cardiac Rehabilitation Trial
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hybrid Cardiac Rehabilitation (HYCR) Behavioral: 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.

Active Comparator: Center Based cardiac Rehabilitation (CBCR) Behavioral: 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).




Primary Outcome Measures :
  1. The number of CR sessions completed within 6 months will be significantly greater in patients randomized to HYCR vs. patients randomized to traditional CBCR (usual care). [ Time Frame: Baseline to 6 months ]
  2. The percentage of patients completing 36 CR sessions within 6 months will be significantly greater among patients randomized to the HYCR program vs. patients randomized to the CBCR program. [ Time Frame: Baseline to 6 months ]

Secondary Outcome Measures :
  1. The improvement in exercise capacity, as measured by distance walked during the six min walk (6MW) test, in patients randomized to HYCR will be equivalent (not inferior) to patients randomized to CBCR. [ Time Frame: Baseline to 6 months ]
  2. The improvement in exercise capacity, as measured by peak oxygen uptake (VO2), in patients randomized to HYCR will be equivalent (not inferior) to patients randomized to CBCR. [ Time Frame: Baseline to 6 months ]
  3. The improvement in quality of life (QOL), as measured by the Short Form Health Survey-12, in patients randomized to HYCR will be equivalent (not inferior) to patients randomized to CBCR. [ Time Frame: Baseline to 6 months ]

Other Outcome Measures:
  1. At 6 months after completing CR, explore the effect of a HYCR on exercise capacity as measured by peak oxygen uptake (VO2) [ Time Frame: Baseline to 6 months ]
  2. At 6 months after completing CR, explore the effect of a HYCR on quality of life (QOL), as measured by the Short Form Health Survey-12. [ Time Frame: Baseline to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646760


Contacts
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Contact: Crystal Grimshaw 313-972-4037 cgrimsh1@hfhs.org
Contact: Matt Saval 313-972-4018 msaval1@hfhs.org

Locations
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United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Steven Keteyian, PhD Henry Ford Health System

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Responsible Party: Steven J. Keteyian, Principal Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03646760     History of Changes
Other Study ID Numbers: HFHS iATTEND
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Angina Pectoris
Heart Valve Diseases
Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms