The Improving ATTENDance to Cardiac Rehabilitation Trial

Not Applicable

Completed

• Conditions: Myocardial Infarction; Angina Pectoris; Heart Valve Diseases; Coronary Artery Disease; Heart Failure; Cardiac Event
• Interventions: Behavioral: HYCR; Behavioral: CBCR

• Registration Number: NCT03646760
• Lead Sponsor: 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-24
• Study Start: 2019-03-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid Cardiac Rehabilitation (HYCR)	HYCR	-
Center Based cardiac Rehabilitation (CBCR)	CBCR	-

Primary Outcome Measures

Name	Time	Method
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).	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.	Baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
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.	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.	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.	Baseline to 6 months

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States