Improving Physical Activity and Cardiac Rehabilitation Attendance Using Technology and Behavioral Economics

NCT ID: NCT04304872

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2024-12-31

Brief Summary

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.

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Gamification

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Loss-Framed Financial Incentives

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Gamification

Intervention Type: BEHAVIORAL

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.

Loss-Framed Financial Incentives

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neel Chokshi, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

2P30AG034546-11

Identifier Type: NIH

Identifier Source: secondary_id

View Link

833631

Identifier Type: -

Identifier Source: org_study_id