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In this RCT, up to 100 adults classified as pre-hypertensive will be randomized to either an artificial intelligence (AI) based lifestyle intervention group or an active control group with a 1 to 1 ratio. Both groups will receive an identical activity tracker (Samsung Galaxy Watch) and BP monitor (Omron Evolv). The AI intervention group will receive automated and personalized lifestyle recommendations based on their lifestyle (e.g. sleep, exercise and diet) and blood pressure (BP) data, involving an automated analytics engine using statistics and machine learning. The active control group will not receive these lifestyle recommendations. The investigators aim to assess objectively the effectiveness of the AI-based personalized lifestyle recommendations on the patients BP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-Based Lifestyle Recommendations Group | Experimental | Participants in this group receive AI-based, personalized lifestyle recommendations based on analysis of their activity tracker and blood pressure data. |
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| Control Group | Active Comparator | Participants in this group do not receive the lifestyle recommendations, but are provided with an identical activity tracker and blood pressure monitor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-Based Lifestyle Recommendations | Behavioral | The intervention provides participants with automated and personalized lifestyle recommendations involving a sophisticated analytics engine using advanced statistics and machine learning. |
| Measure | Description | Time Frame |
|---|---|---|
| Average change in systolic blood pressure (SBP) in experimental vs. control group | Average SBP during the first and last week of a patient's enrollment will be used to calculate SBP change for each patient. | Initial 2 week data collection, weekly lifestyle recommendations, 6 months total |
| Average change in diastolic blood pressure (DBP) in experimental vs. control group | Average DBP during the first and last week of a patient's enrollment will be used to calculate DBP change for each patient. | Initial 2 week data collection, weekly lifestyle recommendations, 6 months total |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients in experimental group that followed lifestyle recommendations | This secondary outcome measure is interested in assessing patient engagement within the experimental group. Data from the activity tracker (steps, sleep quality, active minutes, etc.) will be used to assess whether a patient followed the lifestyle recommendations. | Initial 2 week data collection, weekly lifestyle recommendations, 6 months total |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sujit Dey, PhD | Contact | 8587617518 | dey@eng.ucsd.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Recruiting | La Jolla | California | 92093 | United States |
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| Label | URL |
|---|---|
| Offline and Online Learning Techniques for Personalized Blood Pressure Prediction and Health Behavior Recommendations | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 21, 2022 | |
| Reset | Jan 27, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 21, 2022 | Jan 27, 2023 |
| ID | Term |
|---|---|
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| No Lifestyle Recommendations | Other | The control group receives an identical activity tracker and BP monitor in order to objectively assess the effectiveness of the experimental group intervention. |
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