Acute Coronary Syndrome, Physical Activity
Conditions
Brief summary
This study will use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives. All participants in will establish a baseline step count during the first two weeks and then proceed to a 16-week intervention period and 8-week follow-up period.
Detailed description
Cardiovascular disease is the leading cause of mortality in the United States. Among patients that survive an acute myocardial infarction (AMI), cardiac rehabilitation (CR) has been demonstrated to effectively reduce risk of re-infarction, cardiac mortality, and all-cause mortality. However, despite cardiac rehabilitation being a Class I (standard of care) recommendation in multiple American Heart Association acute myocardial infarction guidelines, more than 80% of eligible patients do not receive appropriate cardiac rehabilitation and much of this is due to challenges in access to these programs. Recent innovations in technology allow us to passively monitor an individual's physical activity using wearable devices. Incentives designed using insights from behavioral economics have been demonstrated to motivate device engagement and behavior change. A remotely-monitored cardiac rehabilitation program could improve access for many individuals and potentially be more cost-effective because it is less resource- and personnel-intensive. The objective of this study is to use a randomized, controlled trial to test the effectiveness of a home-based physical activity program using wearable devices and financial incentives.
Interventions
BEHAVIORALFinancial incentive
A daily financial incentive framed as a loss of $2 each day goal is not acheived
BEHAVIORALDaily feedback
Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥18 years; 2. ability to read and provide informed consent to participate in the study; 3. History of a) acute coronary syndrome (unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction); or b) patients having undergone coronary catheterization for suspected coronary artery disease.
Exclusion criteria
1. Inability to provide informed consent; 2. does not have daily access to a smartphone compatible with the wearable device; 3. unable or unwilling to complete the baseline 6-minute walk test and return to perform the 6-minute walk test at 10 and 18 weeks; 4. already enrolled in an exercise cardiac rehabilitation program prior to hospital admission; 5. hemodynamic instability or New York Heart Association III-IV heart failure; 6. any other medical conditions that would prohibit participation in an 18-week physical activity program; 7. not being discharged to home if recently admitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Daily Steps | Baseline and end of Maintenance Period at Week 16 | The primary outcome variable is the change in mean daily step count from the baseline period to the maintenance period (weeks 9-16). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Daily Steps From Baseline to Follow-up Period | Baseline and end of Follow Up Period at week 24 | Secondary outcomes include change in mean daily steps from the baseline period to the follow-up period (weeks 17-24). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Participants were given standard exercise recommendations that are given to all patients based on the federal guidelines. They also monitored their step counts using a wearable device and received daily feedback. | 55 |
| Intervention Participants were given standard exercise recommendations that are given to all patients based on the federal guidelines. They also monitored their step counts using a wearable device, received daily feedback and were eligible for a financial incentive if their goals were achieved.
Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns Financial incentive: A daily financial incentive framed as a loss of $2 each day goal is not achieved | 50 |
| Total | 105 |
Baseline characteristics
| Characteristic | Total | Control | Intervention |
|---|---|---|---|
| Age, Continuous | 59.5 years STANDARD_DEVIATION 10.6 | 59.1 years STANDARD_DEVIATION 11.5 | 60 years STANDARD_DEVIATION 9.5 |
| Annual household income $50,000 to $100,000 | 24 Participants | 17 Participants | 7 Participants |
| Annual household income Greater than $100,000 | 29 Participants | 12 Participants | 17 Participants |
| Annual household income Less than $50,000 | 39 Participants | 21 Participants | 18 Participants |
| Annual household income Missing | 13 Participants | 5 Participants | 8 Participants |
| Baseline step count | 6876 steps STANDARD_DEVIATION 3163 | 6577 steps STANDARD_DEVIATION 3084 | 7205 steps STANDARD_DEVIATION 3246 |
| Body Mass Index | 30.6 kg/m^2 STANDARD_DEVIATION 6.2 | 30.1 kg/m^2 STANDARD_DEVIATION 5.6 | 31.0 kg/m^2 STANDARD_DEVIATION 6.8 |
| Diabetes mellitus | 33 Participants | 18 Participants | 15 Participants |
| Education College graduate | 50 Participants | 24 Participants | 26 Participants |
| Education High school graduate | 22 Participants | 10 Participants | 12 Participants |
| Education Missing | 1 Participants | 0 Participants | 1 Participants |
| Education Some college or specialized training | 26 Participants | 18 Participants | 8 Participants |
| Education Some high school | 6 Participants | 3 Participants | 3 Participants |
| Ejection fraction | 58.0 Percentage of blood STANDARD_DEVIATION 9.3 | 57.8 Percentage of blood STANDARD_DEVIATION 9.2 | 58.2 Percentage of blood STANDARD_DEVIATION 9.6 |
| Hyperlipidemia | 85 Participants | 45 Participants | 40 Participants |
| Hypertension | 87 Participants | 44 Participants | 43 Participants |
| Insurance Medicaid | 6 Participants | 2 Participants | 4 Participants |
| Insurance Medicare | 45 Participants | 24 Participants | 21 Participants |
| Insurance Military | 2 Participants | 1 Participants | 1 Participants |
| Insurance Private | 52 Participants | 28 Participants | 24 Participants |
| MacNew Heart Disease Health-related Quality of Life questionnaire | 2.6 Units on a scale (7 point scale) STANDARD_DEVIATION 1.2 | 2.7 Units on a scale (7 point scale) STANDARD_DEVIATION 1 | 2.5 Units on a scale (7 point scale) STANDARD_DEVIATION 0.8 |
| Marital Status Married | 64 Participants | 35 Participants | 29 Participants |
| Marital Status Other | 18 Participants | 9 Participants | 9 Participants |
| Marital Status Single | 23 Participants | 11 Participants | 12 Participants |
| Previous cardiac catheterization | 36 Days | 37 Days | 35 Days |
| Previous cardiac catheterization within 90 days preceding enrollment | 78 Participants | 40 Participants | 38 Participants |
| Race/Ethnicity, Customized Black non-Hispanic | 22 Participants | 14 Participants | 8 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized White non-Hispanic | 76 Participants | 38 Participants | 38 Participants |
| Sex: Female, Male Female | 32 Participants | 18 Participants | 14 Participants |
| Sex: Female, Male Male | 73 Participants | 37 Participants | 36 Participants |
| Smoking Active smoker | 9 Participants | 6 Participants | 3 Participants |
| Smoking Past smoker | 47 Participants | 28 Participants | 19 Participants |
| Valvular heart disease | 12 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 50 |
| other Total, other adverse events | 0 / 55 | 0 / 50 |
| serious Total, serious adverse events | 0 / 55 | 0 / 50 |
Outcome results
Primary
Change in Mean Daily Steps
The primary outcome variable is the change in mean daily step count from the baseline period to the maintenance period (weeks 9-16).
Time frame: Baseline and end of Maintenance Period at Week 16
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Change in Mean Daily Steps | 264 Steps |
| Intervention | Change in Mean Daily Steps | 1501 Steps |
Secondary
Change in Mean Daily Steps From Baseline to Follow-up Period
Secondary outcomes include change in mean daily steps from the baseline period to the follow-up period (weeks 17-24).
Time frame: Baseline and end of Follow Up Period at week 24
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Change in Mean Daily Steps From Baseline to Follow-up Period | 92 Steps |
| Intervention | Change in Mean Daily Steps From Baseline to Follow-up Period | 1066 Steps |