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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The investigator plans to assess enrollment rates among two different enrollment methods, while providing a behavioral economic intervention to enhance the uptake of home-health monitoring devices to lower hemoglobin A1C among patients with uncontrolled diabetes. The study is focusing on enrollment methods since the standard randomized control trial only reaches 15% of the population. The study is seeking to understand the effectiveness of a behavioral intervention, when rolled out in a larger population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opt-in Enrollment | Active Comparator | Opt-in enrollment: patient will be sent a recruitment letter, in which they must call the study team to take part in the study. During that call, the study team will schedule the participant for an intake visit. |
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| Opt-out enrollment | Active Comparator | Opt-out enrollment: patient will be sent a letter communicating to them that they have been enrolled into a research program at their doctor's office. After 10 days, the study team will contact the opt-out participants to schedule an intake visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial Incentive: Fixed Lottery | Behavioral | Every day of the 91 day intervention period participants will be asked to use each of their biometric devices. A daily lottery will be conducted automatically by the study website. Participants must use each of their two devices daily to be eligible for the lottery the following day. Winning lottery numbers will be identified by a fixed-position match between the automatically generated winning number and a participant ID number, which each participant will pick at enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment and participation rates | The primary objective is to obtain preliminary evidence regarding whether or not patients opt-into a research study, as opposed to enrolling by default, will affect participation in the program and the effectiveness of the intervention, among high-risk patients. The primary outcome is to measure enrollment rates. The investigators will also measure participation in the program through device usage. | End of study- 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of Device Usage | Assess the effect of financial incentives on the use of home health monitoring devices among high-risk patients | End of study- 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | Assess how regular use of home-based health monitoring devices affects clinical outcomes, such as Hemoglobin A1C | End of study- 6 months after enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaya Aysola, MD, MPH | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |