Back to resultsEffectiveness of BP Remote Monitoring With Virtual Physician Management in Hypertensive Patients.
Primary Purpose
Hypertension, Stroke (CVA) or TIA
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily Blood Pressure Monitoring
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension focused on measuring remote patient monitoring, digital health monitoring, blood pressure monitoring
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
Sites / Locations
- Stanford Stroke Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypertensive Patients Monitored Daily
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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 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)
Participant compliance
Participant compliance, defined as the percentage of days that a patient transmits a vital sign reading on a monthly or weekly basis.
Rate of blood pressure decline
Rate of blood pressure decline
Change in number of antihypertensive drugs
Change in number of antihypertensive drugs prescribed between baseline and the final assessment
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).
Number and types of AEs & SAEs
Number and types of AEs & SAEs
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.
Full Information
NCT ID
NCT05319418
First Posted
April 1, 2022
Last Updated
April 1, 2022
Sponsor
AIRx Health, Inc.
Collaborators
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT05319418
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIRx Health, Inc.
Collaborators
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Stroke (CVA) or TIA
Keywords
remote patient monitoring, digital health monitoring, blood pressure monitoring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypertensive Patients Monitored Daily
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Daily Blood Pressure Monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent patients within target BP
Description
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
Secondary Outcome Measure Information:
Title
Change in average systolic blood pressure
Description
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
Title
Proportion of patients within target BP range
Description
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.
Title
Time taken to achieve a clinically significant reduction in blood pressure
Description
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
Title
Participant compliance
Description
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
Title
Rate of blood pressure decline
Description
Rate of blood pressure decline
Time Frame
Recorded over 24 weeks
Title
Change in number of antihypertensive drugs
Description
Change in number of antihypertensive drugs prescribed between baseline and the final assessment
Time Frame
24 Weeks
Title
Change in number of classes of antihypertensive drugs
Description
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
Title
Number and types of AEs & SAEs
Description
Number and types of AEs & SAEs
Time Frame
Recorded over 24 weeks
Title
Proportions of patients of various BP categories
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Howard
Phone
(408) 837-2211
Email
support@mydailydoctor.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vijay Rajasekhar, MD
Email
support@mydailydoctor.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarten Lansberg, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Stroke Center
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lironn Kraler, MD
Email
lkraler@stanford.edu
First Name & Middle Initial & Last Name & Degree
Maarten Lansberg, MD PhD
Email
lansberg@stanford.edu
First Name & Middle Initial & Last Name & Degree
Lironn Kraler, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31355878
Citation
Kitagawa K, Yamamoto Y, Arima H, Maeda T, Sunami N, Kanzawa T, Eguchi K, Kamiyama K, Minematsu K, Ueda S, Rakugi H, Ohya Y, Kohro T, Yonemoto K, Okada Y, Higaki J, Tanahashi N, Kimura G, Umemura S, Matsumoto M, Shimamoto K, Ito S, Saruta T, Shimada K; Recurrent Stroke Prevention Clinical Outcome (RESPECT) Study Group. Effect of Standard vs Intensive Blood Pressure Control on the Risk of Recurrent Stroke: A Randomized Clinical Trial and Meta-analysis. JAMA Neurol. 2019 Nov 1;76(11):1309-1318. doi: 10.1001/jamaneurol.2019.2167.
Results Reference
background
PubMed Identifier
25873044
Citation
Spruill TM, Williams O, Teresi JA, Lehrer S, Pezzin L, Waddy SP, Lazar RM, Williams SK, Jean-Louis G, Ravenell J, Penesetti S, Favate A, Flores J, Henry KA, Kleiman A, Levine SR, Sinert R, Smith TY, Stern M, Valsamis H, Ogedegbe G. Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black and Hispanic stroke survivors: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:97. doi: 10.1186/s13063-015-0605-5.
Results Reference
background
PubMed Identifier
26551272
Citation
SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9. Erratum In: N Engl J Med. 2017 Dec 21;377(25):2506.
Results Reference
background
PubMed Identifier
27029815
Citation
Ho TW, Huang CT, Chiu HC, Ruan SY, Tsai YJ, Yu CJ, Lai F; HINT Study Group. Effectiveness of Telemonitoring in Patients with Chronic Obstructive Pulmonary Disease in Taiwan-A Randomized Controlled Trial. Sci Rep. 2016 Mar 31;6:23797. doi: 10.1038/srep23797.
Results Reference
background
PubMed Identifier
27699567
Citation
Achelrod D, Schreyogg J, Stargardt T. Health-economic evaluation of home telemonitoring for COPD in Germany: evidence from a large population-based cohort. Eur J Health Econ. 2017 Sep;18(7):869-882. doi: 10.1007/s10198-016-0834-x. Epub 2016 Oct 3. Erratum In: Eur J Health Econ. 2021 Jun;22(4):659-660.
Results Reference
background
PubMed Identifier
31581801
Citation
Weissman GE, Kerlin MP, Yuan Y, Kohn R, Anesi GL, Groeneveld PW, Werner RM, Halpern SD. Potentially Preventable Intensive Care Unit Admissions in the United States, 2006-2015. Ann Am Thorac Soc. 2020 Jan;17(1):81-88. doi: 10.1513/AnnalsATS.201905-366OC.
Results Reference
background
PubMed Identifier
17765133
Citation
Logan AG, McIsaac WJ, Tisler A, Irvine MJ, Saunders A, Dunai A, Rizo CA, Feig DS, Hamill M, Trudel M, Cafazzo JA. Mobile phone-based remote patient monitoring system for management of hypertension in diabetic patients. Am J Hypertens. 2007 Sep;20(9):942-8. doi: 10.1016/j.amjhyper.2007.03.020.
Results Reference
background
PubMed Identifier
17699300
Citation
Stevens LA, Greene T, Levey AS. Surrogate end points for clinical trials of kidney disease progression. Clin J Am Soc Nephrol. 2006 Jul;1(4):874-84. doi: 10.2215/CJN.00600206. Epub 2006 Jun 14. No abstract available.
Results Reference
background
Links:
URL
https://www.mgma.com/MGMA/media/files/fellowship%20papers/2018%20Fellows%20Papers/Neurology-Workforce-Shortage-KB-FACMPE-FINAL-9-20-2018.pdf?ext=.pdf
Description
Citation 14
URL
https://www.cdc.gov/stroke/facts.htm
Description
Citation 13
URL
https://www.aamc.org/system/files/2020-06/stratcomm-aamc-physician-workforce-projections-june-2020.pdf
Description
Citation 12
URL
https://cardio.jmir.org/2019/1/e130/
Description
Citation 11
Learn more about this trial
Effectiveness of BP Remote Monitoring With Virtual Physician Management in Hypertensive Patients.
We'll reach out to this number within 24 hrs