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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04304872
Recruitment Status : Not yet recruiting
First Posted : March 11, 2020
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Pennsylvania

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
Cardiovascular Diseases Behavioral: Gamification Behavioral: Loss-Framed Financial Incentives Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of cardiac rehabilitation sessions attended during intervention [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304872


Contacts
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Contact: Joseph Harrison 2157461249 joseph.harrison@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Contact: Joseph D Harrison    215-746-1249    joseph.harrison@pennmedicine.upenn.edu   
Principal Investigator: Srinath Adusumalli, MD, MS         
Sponsors and Collaborators
University of Pennsylvania
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Srinath Adusumalli, MD, MS University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04304872    
Other Study ID Numbers: 833631
2P30AG034546-11 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
cardiac rehabilitation
physical activity
wearable devices
Additional relevant MeSH terms:
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Cardiovascular Diseases