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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Participants will be given standard exercise recommendations that are given to all patients based on the federal guidelines. They will monitor their step counts using a wearable device and receive daily feedback. |
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| Intervention | Experimental | Participants will be given a wearable device to monitor daily step counts with automated daily feedback on goal attainment via text message or email. A baseline step count will be calculated for each participant (weeks 1-2) and then they will be given a daily step goal with an increase of 15 percentage point each week during the 8-week ramp-up period (weeks 3-10) with a maximum goal of 10,000 steps. Then they'll be asked to maintain that step count (maintenance period). During the ramp-up and maintenance period they'll have a financial incentive of $14 allocated each week and $2 taken away each day the goal is not achieved. They'll be followed up for 8 weeks without incentives |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial incentive | Behavioral | A daily financial incentive framed as a loss of $2 each day goal is not acheived |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and end of Maintenance Period at Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and end of Follow Up Period at week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitesh Patel, MD, MBA, MS | University of Pennsylvania | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32254044 | Derived | Fortunato M, Adusumalli S, Chokshi N, Harrison J, Rareshide C, Patel M. Usability of Wearable Devices to Remotely Monitor Sleep Patterns Among Patients With Ischemic Heart Disease: Observational Study. JMIR Form Res. 2020 Apr 7;4(4):e14508. doi: 10.2196/14508. | |
| 29899015 | Derived | Chokshi NP, Adusumalli S, Small DS, Morris A, Feingold J, Ha YP, Lynch MD, Rareshide CAL, Hilbert V, Patel MS. Loss-Framed Financial Incentives and Personalized Goal-Setting to Increase Physical Activity Among Ischemic Heart Disease Patients Using Wearable Devices: The ACTIVE REWARD Randomized Trial. J Am Heart Assoc. 2018 Jun 13;7(12):e009173. doi: 10.1161/JAHA.118.009173. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Exercise/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. |
| FG001 | Daily Feedback With Financial Incentive | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | 95% Confidence Interval | Steps | Baseline and end of Maintenance Period at Week 16 |
|
Through study completion (6 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participants will be given standard exercise recommendations that are given to all patients based on the federal guidelines. They will monitor their step counts using a wearable device and receive daily feedback. Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns |
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Patients were from 4 hospitals in Southeastern Pennsylvania and had to use a smartphone or tablet. Physical activity measures were limited to only step counts.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mitesh S. Patel | Perelman School of Medicine, University of Pennsylvania | 215-898-3367 | mpatel@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 2, 2016 | Nov 30, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Daily feedback | Behavioral | Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Insurance | Count of Participants | Participants |
|
| Annual household income | Count of Participants | Participants |
|
| Baseline step count | Mean | Standard Deviation | steps |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Ejection fraction | Percentage of blood in the heart that is ejected out to the body with each heartbeat | Mean | Standard Deviation | Percentage of blood |
|
| MacNew Heart Disease Health-related Quality of Life questionnaire | A maximum score of 7 is associated with higher health related quality of life A minimum score of 1 is associated with poorer health related quality of life | Mean | Standard Deviation | Units on a scale (7 point scale) |
|
| Hypertension | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
|
| Previous cardiac catheterization | Median | Inter-Quartile Range | Days |
|
| Previous cardiac catheterization within 90 days preceding enrollment | Count of Participants | Participants |
|
| Smoking | Count of Participants | Participants |
|
| Valvular heart disease | Count of Participants | Participants |
|
|
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| 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). | Posted | Mean | 95% Confidence Interval | Steps | Baseline and end of Follow Up Period at week 24 |
|
|
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| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Intervention | Participants will be given a wearable device to monitor daily step counts with automated daily feedback on goal attainment via text message or email. A baseline step count will be calculated for each participant (weeks 1-2) and then they will be given a daily step goal with an increase of 15 percentage point each week during the 8-week ramp-up period (weeks 3-10) with a maximum goal of 10,000 steps. Then they'll be asked to maintain that step count (maintenance period). During the ramp-up and maintenance period they'll have a financial incentive of $14 allocated each week and $2 taken away each day the goal is not achieved. They'll be followed up for 8 weeks without incentives Financial incentive: A daily financial incentive framed as a loss of $2 each day goal is not acheived Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns | 0 | 50 | 0 | 50 | 0 | 50 |
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| D014652 |
| Vascular Diseases |