The Improving ATTENDance to Cardiac Rehabilitation Trial (iATTEND)

February 28, 2024 updated by: Steven J. Keteyian, Henry Ford Health System
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

282

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline to 6 months
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
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline to 6 months
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
Baseline to 6 months
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
Baseline to 6 months

Other Outcome Measures

Outcome Measure
Time Frame
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
Baseline to 6 months
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
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Steven Keteyian, PhD, Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFHS iATTEND
  • R33HL143099 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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