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| Name | Class |
|---|---|
| HealthPals, Inc | UNKNOWN |
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This platform will enable investigation the cardiovascular risk reduction and the increase in participant engagement in their heart-healthy goals, through the use of virtual care/telemedicine with a digital platform that connects them to their own doctors, nurses, and dietitians.
The study will use telemedicine and the mobile health capabilities of smartphones to facilitate communication of medical goals set by the treating physician to the subject in between clinic visits, and to assess the daily medical and lifestyle change compliance of enrolled Stanford subjects and provide virtual health coaching, as needed, to subjects to achieve said goals. How patients comply with their specific medical and lifestyle goals all affect their cardiovascular health, yet largely go unmeasured. These can now be measured with a notification-based system in which subject-entered activity, medication compliance, and dietary reporting data will be collected, assessed, and trigger appropriate responses by the subject's Care Team, which includes their physician, nurse, dietitian, and assigned health coach. We aim to collect this subject-reported activity and cardiovascular care plan compliance data to provide much more quantitative data on type, duration, and intensity of daily activities and compliance with the medication regimens of enrolled subjects.
The study will compare anthropometric cardiovascular risk biomarkers testing at the initial visit and after 3 months, in subjects utilizing the HealthPals digital platform PLUS the standard SSATHI clinic visits, versus subjects receiving only SSATHI clinic visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B/ HealthPals | Experimental | Group B have access to HealthPals app where they will coordinate with a trained health coach Group B patients will only come into SSATHI clinic to see their doctor for an initial visit and 6 month follow up, and they will have a telephone visit with their doctor at 3 months instead of an in-clinic visit Lab testing is the same for both Group A/ control and Group B patients |
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| Group A/ Control | No Intervention | Group B will not have access to HealthPals app Group A patients will come into SSATHI clinic to see their doctor for an initial visit, a 3 month follow up, and a 6 month follow up Lab testing is the same for both Group A/ control and Group B patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of HealthPals (Telemedicine supported by digital health platform) | Behavioral | HealthPals is a smartphone-based chronic disease management mobile application. It uses the mobile health capabilities of smartphones to provide a secure communication portal for patients with their Care Teams to help achieve cardiovascular risk reduction through a digital health coach-based coaching for lifestyle and medication compliance. The HealthPals app was developed by HealthPals, Inc. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in exercise activity over 6 months | Patients are given exercise recommendations (or physical activity goals depending on the patient's capacity for exercise) at the time of the initial visit by the HealthPals health coach. The patients will input their activity into the HealthPals platform at time points of their convenience during their 6 month involvement in the study, and this data will be securely aggregated within the platform. The HealthPals health coach who has access to this data will compile and analyze the data and also send it back to the patients' providers by means of final health reports, assessing the change of exercise activity over the duration of the patient's involvement in the study. | 6 months or through study completion |
| Measuring medication compliance | The patients will input their compliance to their medication regimen into the HealthPals platform at time points of their convenience, and this data will be securely aggregated within the platform. The HealthPals health coach who has access to this data will compile and analyze the data and also send it back to the patients' providers by means of final reports. | Monthly assessment and report for duration of their involvement in the study |
| Measuring trends in Blood Pressure measurements | The patients will input their blood pressure in mmHg at time points of their convenience into the HealthPals platform, and this data will be securely aggregated within the platform. The HealthPals health coach who has access to this data will compile and analyze the data and also send it back to the patients' providers by means of monthly health reports. | Monthly assessment and report for duration of their involvement in the study |
| Measuring trends in weight measurements | The patients will input their weight in kg at time points of their convenience into the HealthPals platform, and this data will be securely aggregated within the platform. The HealthPals health coach who has access to this data will compile and analyze the data and also send it back to the patients' providers by means of monthly health reports. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fahim Abbasi, MD | Stanford University | Principal Investigator |
| Shriram Nallamshetty, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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Group A Control Group B HealthPals
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| Monthly assessment and report for duration of their involvement in the study |
| Measuring compliance to dietary recommendations | Patients are given dietary recommendations at the time of their initial visit by the HealthPals health coach. After the first visit the patients will input their diet into the HealthPals platform at time points of their convenience, and this data will be securely aggregated within the platform. The HealthPals health coach who has access to this data will compile and analyze the data and also send it back to the patients' providers by means of monthly health reports. | Monthly assessment and report for duration of their involvement in the study |
| Initial User Assessment | Questionnaire covering personal history, family history, typical diet, exercise and activity, and stress level quantification. This questionnaire is used for a baseline analysis of the patients' health status by the HealthPals health coach. | Questionnaire administered at time of initial visit |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D011236 | Prediabetic State |
| D003920 | Diabetes Mellitus |
| D003324 | Coronary Artery Disease |
| D006973 | Hypertension |
| D058246 | Prehypertension |
| D050171 | Dyslipidemias |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D052439 | Lipid Metabolism Disorders |
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