Improving Physical Activity and Cardiac Rehabilitation Attendance Using Technology and Behavioral Economics (IMPACT-CR)

The objective of this study is to test the feasibility of using behavioral economic interventions (gamification with and without loss-framed financial incentives) targeting daily steps counts to improve cardiac rehabilitation attendance.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Gamification; Behavioral: Loss-Framed Financial Incentives

Detailed Description

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States. Cardiac rehabilitation is a multifaceted physical activity program that incorporates medication adherence, smoking cessation, nutrition, and psychological counseling. Implementation of cardiac rehabilitation among those with cardiovascular disease (including ischemic heart disease, heart failure, and valvular heart disease) has been shown to increase physical activity and reduce cardiovascular mortality, morbidity, and hospital readmission rates. Cardiac rehabilitation carries a class I indication (standard of care) for post-acute coronary syndrome, post-percutaneous coronary intervention, in patients undergoing coronary artery bypass grafting/valve surgery, in patients with stable angina, and in patients with chronic heart failure per American College of Cardiology guidelines. Patient attendance and completion rates of a full regimen of cardiac rehabilitation therapy have been shown to be < 40% of those referred, depriving many eligible patients of the benefits of cardiac rehabilitation. The objective of this study is to test the feasibility of using behavioral economic interventions targeting daily step goals using wearable activity monitors to improve cardiac rehabilitation attendance among patients already referred for cardiac rehabilitation. We will compare three groups of 30 patients each as follows: 1) behaviorally designed gamification with social support; 2) loss-framed financial incentives; and 3) behaviorally designed gamification with social support AND loss-framed financial incentives.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Perelman Center for Advanced Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age greater than 18;
• Ability to consent;
• Patients with diagnosis of stable angina, chronic systolic heart failure, post- percutaneous coronary intervention, post-coronary artery bypass grafting surgery, post-acute myocardial infarction, and post-valvular repair who were discharged after an inpatient admission within the last 12 months;
• Smartphone or tablet compatible with application for the wearable activity tracking device;
• Independence Blue Cross health insurance coverage.

Exclusion Criteria:

• Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English;
• Already enrolled in another study targeting physical activity;
• Medical condition preventing participation in a physical activity program;
• Prior or ongoing enrollment in cardiac rehabilitation;
• Baseline step count > 7,500 steps per day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gamification Intervention; Participants sign a pledge agreeing to try their best to meet their goals. Participants are entered into a game. Each week they receive 70 points. Each day, they are told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels. Participants choose a support partner who receives a weekly email with the participant's progress. The study group will hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. At 6 weeks, the study group will have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.	Behavioral: Gamification; Participants sign a pledge agreeing to try their best to meet their goals. Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels. Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. At 6 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
Experimental: Loss-Framed Financial Incentive Intervention; Participants are informed that each week that $14 is placed in a virtual account for them. Each day, the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that $2 was taken away.	Behavioral: Loss-Framed Financial Incentives; Participants are informed that each week $14 is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that $2 was taken away.
Experimental: Gamification and Loss-Framed Financial Incentive Intervention; Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.	Behavioral: Gamification; Participants sign a pledge agreeing to try their best to meet their goals. Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels. Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. At 6 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.; Behavioral: Loss-Framed Financial Incentives; Participants are informed that each week $14 is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that $2 was taken away.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cardiac rehabilitation sessions attended during intervention	The primary outcome is the number of CR sessions attended during the 12-week intervention period.	Baseline to 12-week intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients that attend 30 of the 36 cardiac rehabilitation sessions during intervention	The secondary outcome includes the proportion of patients that attend at least 30 of the 36 CR sessions during the 12-week intervention period.	Baseline to 12-week intervention period
Change in mean daily step counts from baseline to 12-week period	The secondary outcomes include the change in daily step counts from baseline to the 12-week intervention period.	Baseline to 12-week intervention period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants that identified a support partner	We will explore measures of intervention acceptability and feasibility including the proportion of participants that identified a support partner.	Baseline to 12-week intervention period
Proportion of participants that completed the entire study	We will explore measures of intervention acceptability and feasibility including the proportion of participants that completed the entire study.	Baseline to 12-week intervention period
Proportion of days that wearable device was used	We will explore measures of intervention acceptability and feasibility including the proportion of days that the wearable device was used.	Baseline to 12-week intervention period

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Neel Chokshi, MD, MBA, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; cardiac rehabilitation; wearable devices
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 833631; 2P30AG034546-11 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No