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

NCT04304872 | Withdrawn

• 2 other identifiers: 8336312P30AG034546-11
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

cardiac rehabilitation; physical activity; wearable devices

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of patients that attend 30 of the 36 cardiac rehabilitation sessions during intervention

  Baseline to 12-week intervention period

• Change in mean daily step counts from baseline to 12-week period

  Baseline to 12-week intervention period

Other Outcomes (3)

• Proportion of participants that identified a support partner

  Baseline to 12-week intervention period

• Proportion of participants that completed the entire study

  Baseline to 12-week intervention period

• Proportion of days that wearable device was used

  Baseline to 12-week intervention period

Study Arms (3)

Gamification Intervention

EXPERIMENTAL

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

Loss-Framed Financial Incentive Intervention

EXPERIMENTAL

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

Gamification and Loss-Framed Financial Incentive Intervention

EXPERIMENTAL

Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.

Behavioral: Gamification; Behavioral: Loss-Framed Financial Incentives

Interventions

Gamification 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.

Gamification Intervention; Gamification and Loss-Framed Financial Incentive Intervention

Loss-Framed Financial Incentives 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; Loss-Framed Financial Incentive Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Neel Chokshi, MD, MBA

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 11, 2020
• Study Start: October 31, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)