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The Improving ATTENDance to Cardiac Rehabilitation Trial (iATTEND)

Primary Purpose

Myocardial Infarction, Heart Failure, Heart Valve Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HYCR
CBCR
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henry Ford Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hybrid Cardiac Rehabilitation (HYCR)

Center Based cardiac Rehabilitation (CBCR)

Arm Description

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 14, 2018
Last Updated
September 21, 2023
Sponsor
Henry Ford Health System
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03646760
Brief Title
The Improving ATTENDance to Cardiac Rehabilitation Trial
Acronym
iATTEND
Official Title
The Improving ATTENDance to Cardiac Rehabilitation Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

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

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Heart Failure, Heart Valve Diseases, Cardiac Event, Angina Pectoris, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hybrid Cardiac Rehabilitation (HYCR)
Arm Type
Experimental
Arm Title
Center Based cardiac Rehabilitation (CBCR)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
HYCR
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBCR
Intervention Description
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 Measure Information:
Title
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
Title
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 Measure Information:
Title
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
Title
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
Title
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 Pre-specified Outcome Measures:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Keteyian, PhD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33351540
Citation
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.
Results Reference
derived

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The Improving ATTENDance to Cardiac Rehabilitation Trial

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