Clinical trial NCT04304872: Improving Physical Activity and Cardiac Rehabilitation Attendance Using Technology and Behavioral Economics
Official title: Improving Physical Activity and Cardiac Rehabilitation Attendance Using Technology and Behavioral Economics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: cardiac rehabilitation
physical activity
wearable devices
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-03-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of cardiac rehabilitation sessions attended during intervention
timeFrame: Baseline to 12-week intervention period
Secondary outcomes:
measure: Proportion of patients that attend 30 of the 36 cardiac rehabilitation sessions during intervention
timeFrame: Baseline to 12-week intervention period
measure: Change in mean daily step counts from baseline to 12-week period
timeFrame: Baseline to 12-week intervention period
Other outcomes:
measure: Proportion of participants that identified a support partner
timeFrame: Baseline to 12-week intervention period
measure: Proportion of participants that completed the entire study
timeFrame: Baseline to 12-week intervention period
measure: Proportion of days that wearable device was used
timeFrame: Baseline to 12-week intervention period
Locations:
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Neel Chokshi, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: