Effectiveness of BP Remote Monitoring With Virtual Physician Management in Hypertensive Patients.

Study Overview
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Brief Summary
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To assess the feasibility and adoptability of DailyDoctor's remote monitoring clinical decision support software tool in helping physicians virtually manage systolic blood pressures among patients with history of stroke or TIA to a target systolic blood pressure (<140 mmHg or a lower target range specified by referring physicians) using remote monitoring and independent clinical judgement.

Detailed Description
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To assess the feasibility and adoptability of DailyDoctor's remote monitoring clinical decision support software tool in helping physicians virtually manage systolic blood pressures among patients with history of stroke or TIA to a target systolic blood pressure (<140 mmHg or a lower target range specified by referring physicians) using remote monitoring and independent clinical judgement. To assess the feasibility and adoptability of DailyDoctor's digital platform in helping Stanford Stroke Center lower and maintain systolic blood pressures among patients with history of stroke or TIA to a target systolic blood pressure (<140 mmHg or a lower target range specified by referring physicians) using remote monitoring and a virtual medical team focused on BP management.

Official Title
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PILOT: Effectiveness of BP Remote Monitoring Software With Virtual Physician Management in Stage 2 Hypertension Patients With History of Stroke or TIA.

Conditions
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Hypertension, Stroke (CVA) or TIA

Intervention / Treatment
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* Behavioral: Daily Blood Pressure Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older. A history of ischemic or hemorrhagic stroke, or transient ischemic attack. The ability to report blood pressure values by phone (either a patient or designated caregiver may call to report values). At least 2 BP measurements that are ≥140 mmHg systolic or ≥90 mmHg diastolic obtained on different days in the last 6 months in any setting (including at home, in clinic, or in the hospital setting). The referring physician feels the patient would benefit from BP optimization. Consent to receive care from telehealth physicians available through the DailyDoctor monitoring platform. English or Spanish speaking. Exclusion Criteria: Currently enrolled in another interventional research study Inability to comply with study protocol Have a planned surgical procedure during the study period Upper arm circumference > 20 inches Has diagnosis of end-stage renal disease (GFR < 15 mL/min), Serum creatinine > 2.0 mg/dL (176.8 μmol/L), or currently undergoing dialysis treatment (10) Women who are pregnant or who are planning to become pregnant during the study period. Blood pressure reduction is not indicated (e.g. patients who have a high blood pressure target to augment cerebral perfusion). Any other reason that, in the opinion of the investigator, makes the person a poor candidate for participation in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertensive Patients Monitored Daily<br>Physicians utilize DailyDoctor remote monitoring platform to virtually monitor daily BP of patients. Physicians use their independent medical judgement to recommend any clinical follow up or adjustment in medications/prescriptions for any patients whose daily reporting of BP triggers an alert based on physician-driven alert thresholds. | Behavioral: Daily Blood Pressure Monitoring<br>* Patients are provided standard off-the-shelf blood pressure monitors and take their BP vitals daily. Patients report their daily BP through phone or online. BP data is viewed online by physicians who use their independent medical judgement for any changes in medical management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent patients within target BP | The change in the percentage of patients who are within their target blood pressure range between baseline (based on the average of the first 5 BP readings recorded by the patient using the DailyDoctor platform) and at the completion of the 24 week interv | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average systolic blood pressure | The average systolic blood pressure of the first 5 BP readings recorded by a patient using the DailyDoctor platform will be compared to the average of the last 5 readings of systolic blood pressure reported by the patient using the DailyDoctor platform. | 24 Weeks | 
| Proportion of patients within target BP range | Proportions of patients who are within their target blood pressure range during every 4-week period over 24 weeks. | Every 4-week period over 24 weeks. | 
| Time taken to achieve a clinically significant reduction in blood pressure | Time taken to achieve a clinically significant reduction in blood pressure (5mmHg for systolic blood pressure or 2.5 mmHg in diastolic blood pressure) | Varies, recorded over 24 weeks | 
| Participant compliance | Participant compliance, defined as the percentage of days that a patient transmits a vital sign reading on a monthly or weekly basis. | Recorded over 24 weeks | 
| Rate of blood pressure decline | Rate of blood pressure decline | Recorded over 24 weeks | 
| Change in number of antihypertensive drugs | Change in number of antihypertensive drugs prescribed between baseline and the final assessment | 24 Weeks | 
| Change in number of classes of antihypertensive drugs | Change in number of classes of antihypertensive drugs prescribed between baseline and the final assessment with 5 predefined classes: diuretics, angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, calcium channel blockers, β-blockers, and others (α-blockers, hydralazine, minoxidil, clonidine, reserpine, guanethidine, and methyldopa). | 24 Weeks | 
| Number and types of AEs & SAEs | Number and types of AEs & SAEs | Recorded over 24 weeks | 
| Proportions of patients of various BP categories | Based on weekly and 4-weekly blood pressure averages, the proportions of patients who are classified as: Normal (<120 mmHg systolic/ <80 mmHg diastolic) Elevated (120-129 mmHg systolic/ <80 mmHg diastolic). Stage 1 hypertensive: systolic pressure ranging from 130 to 139 mm Hg or a diastolic pressure ranging from 80 to 89 mm Hg. Stage 2 hypertensive: systolic pressure ≥140 mm Hg or a diastolic pressure ≥90 mm Hg. | Recorded over 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote patient monitoring, digital health monitoring, blood pressure monitoring