Evaluating Increasing Physical Activity After Acute Coronary Syndrome

NCT02531022 | Completed Results

• 1 other identifier: 823025
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Physical Activity; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Mean Daily Steps From Baseline to Follow-up Period

  Baseline and end of Follow Up Period at week 24

Study Arms (2)

Control

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.

Behavioral: Daily feedback

Intervention

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

Behavioral: Financial incentive; Behavioral: Daily feedback

Interventions

Financial incentive BEHAVIORAL

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

Intervention

Daily feedback BEHAVIORAL

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

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Related Publications (2)

• 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.

  PMID: 32254044 DERIVED

• 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.

  PMID: 29899015 DERIVED

MeSH Terms

Conditions

Motor Activity; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Behavior; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Limitations and Caveats

Patients were from 4 hospitals in Southeastern Pennsylvania and had to use a smartphone or tablet. Physical activity measures were limited to only step counts.

Results Point of Contact

• Title: Dr. Mitesh S. Patel
• Organization: Perelman School of Medicine, University of Pennsylvania

mpatel@pennmedicine.upenn.edu

215-898-3367

Study Officials

• Mitesh Patel, MD, MBA, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 21, 2015
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: April 3, 2017
• Last Updated: July 11, 2019
• Results First Posted: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share