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

Sponsor
University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04304872
Collaborator
National Institute on Aging (NIA) (NIH)
90
1
3
16.2
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Gamification
  • Behavioral: Loss-Framed Financial Incentives
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Improving Physical Activity and Cardiac Rehabilitation Attendance Using Technology and Behavioral Economics
Anticipated Study Start Date :
Jul 26, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of cardiac rehabilitation sessions attended during intervention [Baseline to 12-week intervention period]

    The primary outcome is the number of CR sessions attended during the 12-week intervention period.

Secondary Outcome Measures

  1. Proportion of patients that attend 30 of the 36 cardiac rehabilitation sessions during intervention [Baseline to 12-week intervention period]

    The secondary outcome includes the proportion of patients that attend at least 30 of the 36 CR sessions during the 12-week intervention period.

  2. Change in mean daily step counts from baseline to 12-week period [Baseline to 12-week intervention period]

    The secondary outcomes include the change in daily step counts from baseline to the 12-week intervention period.

Other Outcome Measures

  1. Proportion of participants that identified a support partner [Baseline to 12-week intervention period]

    We will explore measures of intervention acceptability and feasibility including the proportion of participants that identified a support partner.

  2. Proportion of participants that completed the entire study [Baseline to 12-week intervention period]

    We will explore measures of intervention acceptability and feasibility including the proportion of participants that completed the entire study.

  3. Proportion of days that wearable device was used [Baseline to 12-week intervention period]

    We will explore measures of intervention acceptability and feasibility including the proportion of days that the wearable device was used.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Perelman Center for Advanced Medicine Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Srinath Adusumalli, MD, MS, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT04304872
Other Study ID Numbers:
  • 833631
  • 2P30AG034546-11
First Posted:
Mar 11, 2020
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022