Evaluating Increasing Physical Activity After Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
A Randomized, Controlled Trial Evaluating Methods to Use Physical Activity to Improve Outcomes After Acute Coronary Syndrome

Conditions
-----------------
Physical Activity, Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Behavioral: Financial incentive
* Behavioral: Daily feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years; ability to read and provide informed consent to participate in the study; 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: Inability to provide informed consent; does not have daily access to a smartphone compatible with the wearable device; 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; already enrolled in an exercise cardiac rehabilitation program prior to hospital admission; hemodynamic instability or New York Heart Association III-IV heart failure; any other medical conditions that would prohibit participation in an 18-week physical activity program; not being discharged to home if recently admitted.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Participants will be given standard exercise recommendations that are given to all patients based on the federal guidelines. They will monitor their step counts using a wearable device and receive daily feedback. | Behavioral: Daily feedback<br>* Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns<br>|
| Experimental: Intervention<br>Participants will be given a wearable device to monitor daily step counts with automated daily feedback on goal attainment via text message or email. A baseline step count will be calculated for each participant (weeks 1-2) and then they will be given a daily step goal with an increase of 15 percentage point each week during the 8-week ramp-up period (weeks 3-10) with a maximum goal of 10,000 steps. Then they'll be asked to maintain that step count (maintenance period). During the ramp-up and maintenance period they'll have a financial incentive of $14 allocated each week and $2 taken away each day the goal is not achieved. They'll be followed up for 8 weeks without incentives | Behavioral: Financial incentive<br>* A daily financial incentive framed as a loss of $2 each day goal is not acheived<br>Behavioral: Daily feedback<br>* Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Daily Steps | The primary outcome variable is the change in mean daily step count from the baseline period to the maintenance period (weeks 9-16). | Baseline and end of Maintenance Period at Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Daily Steps From Baseline to Follow-up Period | Secondary outcomes include change in mean daily steps from the baseline period to the follow-up period (weeks 17-24). | Baseline and end of Follow Up Period at week 24 |