Evaluating Increasing Physical Activity After Acute Coronary Syndrome

NCT ID: NCT02531022

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-04-03

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.

Conditions

Physical Activity; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: ACTIVE_COMPARATOR

Daily feedback

Intervention Type: BEHAVIORAL

Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns

Intervention

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

Group Type: EXPERIMENTAL

Financial incentive

Intervention Type: BEHAVIORAL

A daily financial incentive framed as a loss of $2 each day goal is not acheived

Daily feedback

Intervention Type: BEHAVIORAL

Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns

Interventions

Financial incentive

A daily financial incentive framed as a loss of $2 each day goal is not acheived

Intervention Type: BEHAVIORAL

Daily feedback

Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitesh Patel, MD, MBA, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

References

Fortunato M, Adusumalli S, Chokshi N, Harrison J, Rareshide C, Patel M. Usability of Wearable Devices to Remotely Monitor Sleep Patterns Among Patients With Ischemic Heart Disease: Observational Study. JMIR Form Res. 2020 Apr 7;4(4):e14508. doi: 10.2196/14508.

Reference Type: DERIVED

PMID: 32254044 (View on PubMed)

Chokshi NP, Adusumalli S, Small DS, Morris A, Feingold J, Ha YP, Lynch MD, Rareshide CAL, Hilbert V, Patel MS. Loss-Framed Financial Incentives and Personalized Goal-Setting to Increase Physical Activity Among Ischemic Heart Disease Patients Using Wearable Devices: The ACTIVE REWARD Randomized Trial. J Am Heart Assoc. 2018 Jun 13;7(12):e009173. doi: 10.1161/JAHA.118.009173.

Reference Type: DERIVED

PMID: 29899015 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

823025

Identifier Type: -

Identifier Source: org_study_id