Evaluating Increasing Physical Activity After Acute Coronary Syndrome
This trial is active, not recruiting.
|Conditions||physical activity, acute coronary syndrome|
|Treatments||financial incentive, daily feedback|
|Sponsor||University of Pennsylvania|
|Start date||February 2016|
|End date||January 2017|
|Trial size||105 participants|
|Trial identifier||NCT02531022, 823025|
This study will use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives. All participants in will establish a baseline step count during the first two weeks and then proceed to a 16-week intervention period and 8-week follow-up period.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Change in mean daily steps
time frame: 8-week maintenance intervention period compared to baseline period
Change in mean daily steps
time frame: 8-week follow-up period compared to baseline period
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Age ≥18 years; 2. ability to read and provide informed consent to participate in the study; 3. History of a) acute coronary syndrome (unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction); or b) patients having undergone coronary catheterization for suspected coronary artery disease. Exclusion Criteria: 1. Inability to provide informed consent; 2. does not have daily access to a smartphone compatible with the wearable device; 3. unable or unwilling to complete the baseline 6-minute walk test and return to perform the 6-minute walk test at 10 and 18 weeks; 4. already enrolled in an exercise cardiac rehabilitation program prior to hospital admission; 5. hemodynamic instability or New York Heart Association III-IV heart failure; 6. any other medical conditions that would prohibit participation in an 18-week physical activity program; 7. not being discharged to home if recently admitted.
|Official title||A Randomized, Controlled Trial Evaluating Methods to Use Physical Activity to Improve Outcomes After Acute Coronary Syndrome|
|Principal investigator||Mitesh Patel, MD, MBA, MS|
|Description||Cardiovascular disease is the leading cause of mortality in the United States. Among patients that survive an acute myocardial infarction (AMI), cardiac rehabilitation (CR) has been demonstrated to effectively reduce risk of re-infarction, cardiac mortality, and all-cause mortality. However, despite cardiac rehabilitation being a Class I (standard of care) recommendation in multiple American Heart Association acute myocardial infarction guidelines, more than 80% of eligible patients do not receive appropriate cardiac rehabilitation and much of this is due to challenges in access to these programs. Recent innovations in technology allow us to passively monitor an individual's physical activity using wearable devices. Incentives designed using insights from behavioral economics have been demonstrated to motivate device engagement and behavior change. A remotely-monitored cardiac rehabilitation program could improve access for many individuals and potentially be more cost-effective because it is less resource- and personnel-intensive. The objective of this study is to use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives.|
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