An interventional study of Daily Blood Pressure Monitoring in Hypertension and Stroke (CVA) or TIA, sponsored by AIRx Health, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by AIRx Health, Inc. · Not applicable, Interventional, and Prevention
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 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.
6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's planned enrollment of 50 is below the median of 90 across 4,994 interventional studies indexed under Hypertension.
Browse Hypertension studies →This is the only study on the registry with AIRx Health, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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
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
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.
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
Time frame: 24 Weeks
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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: Recorded over 24 weeks
Rate of blood pressure decline
Rate of blood pressure decline
Time frame: Recorded over 24 weeks
Change in number of antihypertensive drugs
Change in number of antihypertensive drugs prescribed between baseline and the final assessment
Time frame: 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).
Time frame: 24 Weeks
Number and types of AEs & SAEs
Number and types of AEs \& SAEs
Time frame: 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.
Time frame: Recorded over 24 weeks
Plan to share: No
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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