Overview

This trial is active, not recruiting.

Conditions physical activity, acute coronary syndrome
Treatments financial incentive, daily feedback
Phase phase 3
Sponsor University of Pennsylvania
Start date February 2016
End date January 2017
Trial size 105 participants
Trial identifier NCT02531022, 823025

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
daily feedback
Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns
(Experimental)
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
financial incentive
A daily financial incentive framed as a loss of $2 each day goal is not acheived
daily feedback
Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns

Primary Outcomes

Measure
Change in mean daily steps
time frame: 8-week maintenance intervention period compared to baseline period

Secondary Outcomes

Measure
Change in mean daily steps
time frame: 8-week follow-up period compared to baseline period

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.