Clinical trial NCT05319418: Effectiveness of BP Remote Monitoring With Virtual Physician Management in Hypertensive Patients.
Official title: PILOT: Effectiveness of BP Remote Monitoring Software With Virtual Physician Management in Stage 2 Hypertension Patients With History of Stroke or TIA.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Stroke (CVA) or TIA
Keywords: remote patient monitoring
digital health monitoring
blood pressure monitoring
Lead sponsor: AIRx Health, Inc.
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2022-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent patients within target BP
timeFrame: 24 Weeks
Secondary outcomes:
measure: Change in average systolic blood pressure
timeFrame: 24 Weeks
measure: Proportion of patients within target BP range
timeFrame: Every 4-week period over 24 weeks.
measure: Time taken to achieve a clinically significant reduction in blood pressure
timeFrame: Varies, recorded over 24 weeks
measure: Participant compliance
timeFrame: Recorded over 24 weeks
measure: Rate of blood pressure decline
timeFrame: Recorded over 24 weeks
measure: Change in number of antihypertensive drugs
timeFrame: 24 Weeks
measure: Change in number of classes of antihypertensive drugs
timeFrame: 24 Weeks
measure: Number and types of AEs & SAEs
timeFrame: Recorded over 24 weeks
measure: Proportions of patients of various BP categories
timeFrame: Recorded over 24 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Stroke Center
state: California
Study officials:
affiliation: Stanford University
name: Maarten Lansberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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