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

NCT ID: NCT05319418

Last Updated: 2022-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2023-03-31

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.

Conditions

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Hypertension Stroke (CVA) or TIA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hypertensive Patients Monitored Daily

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.

Group Type EXPERIMENTAL

Daily Blood Pressure Monitoring

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

AIRx Health, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maarten Lansberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Stroke Center

Stanford, California, United States

Site Status

Countries

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United States

Central Contacts

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Michelle Howard

Role: CONTACT

(408) 837-2211

Vijay Rajasekhar, MD

Role: CONTACT

Facility Contacts

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Lironn Kraler, MD

Role: primary

Maarten Lansberg, MD PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 31355878 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25873044 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26551272 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27029815 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27699567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31581801 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17765133 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17699300 (View on PubMed)

Other Identifiers

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61821

Identifier Type: -

Identifier Source: org_study_id

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