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Hybrid Cardiac Rehabilitation for Cardiovascular Disease (iATTEND Trial)
N/A
Waitlist Available
Led By Steven Keteyian, PhD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights
iATTEND Trial Summary
This trial will assess the efficacy of an innovative approach to cardiac rehabilitation that combines both center-based and remote- or home-based CR sessions.
Who is the study for?
This trial is for adults aged 18-85 in the Detroit area who've had a recent cardiac event or have stable heart conditions. They must be able to attend some rehab sessions, do exercises at home, and use internet-connected devices. Exclusions include severe heart issues, advanced cancer, cognitive impairments that limit participation, pregnancy plans within a year, or involvement in another conflicting clinical trial.Check my eligibility
What is being tested?
The study tests an innovative cardiac rehabilitation (CR) approach combining center-based CR with remote/home-based CR tailored to each patient using telemedicine. It aims to improve attendance and maximize the benefits of CR by making it more accessible and personalized.See study design
What are the potential side effects?
Since this trial involves exercise and rehabilitation activities rather than medication, side effects may include typical exercise-related risks such as muscle soreness or strain. The specific side effects will depend on individual health conditions.
iATTEND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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.
Other outcome measures
At 6 months after completing CR, explore the effect of a HYCR on exercise capacity as measured by peak oxygen uptake (VO2)
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.
iATTEND Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hybrid Cardiac Rehabilitation (HYCR)Experimental Treatment1 Intervention
Group II: Center Based cardiac Rehabilitation (CBCR)Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HYCR
2019
N/A
~290
Find a Location
Who is running the clinical trial?
Henry Ford Health SystemLead Sponsor
302 Previous Clinical Trials
2,102,950 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,817,954 Total Patients Enrolled
Steven Keteyian, PhDPrincipal InvestigatorHenry Ford Health System
1 Previous Clinical Trials
16 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a heart device on the left side, need continuous support medication for your heart, or are undergoing hemodialysis.You have chest pain at rest or with light physical activity.You have advanced cancer, high risk of falling, severe memory problems, or other serious conditions that make it hard for you to take part in the study.You are expected to live for less than 12 months.You have had a serious heart problem in the past 6 months or have been diagnosed with certain heart conditions.You are between 18 and 85 years old.You will take a test to see how well you can remember and think. If you score below 3, you may not be able to join the study.You have a serious heart rhythm problem, unless it has been treated with a device like an implantable cardiac defibrillator.You are planning to have a major heart procedure or be hospitalized in the next 6 months.Your risk for falling will be checked by how long it takes you to stand up and sit down 5 times. If it takes you longer than 15 seconds, you may be at higher risk for falling.
Research Study Groups:
This trial has the following groups:- Group 1: Hybrid Cardiac Rehabilitation (HYCR)
- Group 2: Center Based cardiac Rehabilitation (CBCR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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