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

NCT05319418 | Unknown

• 1 other identifier: 61821
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Stroke (CVA) or TIA

Keywords

remote patient monitoring; digital health monitoring; blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in average systolic blood pressure

  24 Weeks

• Proportion of patients within target BP range

  Every 4-week period over 24 weeks.

• Time taken to achieve a clinically significant reduction in blood pressure

  Varies, recorded over 24 weeks

• Participant compliance

  Recorded over 24 weeks

• Rate of blood pressure decline

  Recorded over 24 weeks

Study Arms (1)

Hypertensive Patients Monitored Daily

EXPERIMENTAL

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

Interventions

Daily Blood Pressure Monitoring 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.

Hypertensive Patients Monitored Daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AIRx Health, Inc.: lead
• Stanford University: collaborator

Study Sites (1)

Stanford Stroke Center

Stanford, California, 94304, United States

Location

Related Publications (8)

• 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.

  PMID: 31355878 BACKGROUND

• 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.

  PMID: 25873044 BACKGROUND

• 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.

  PMID: 26551272 BACKGROUND

• 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.

  PMID: 27029815 BACKGROUND

• 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.

  PMID: 27699567 BACKGROUND

• 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.

  PMID: 31581801 BACKGROUND

• 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.

  PMID: 17765133 BACKGROUND

• 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.

  PMID: 17699300 BACKGROUND

Related Links

• Citation 14
• Citation 11

MeSH Terms

Conditions

Hypertension; Stroke

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Maarten Lansberg, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Howard

CONTACT

(408) 837-2211; support@mydailydoctor.com

Vijay Rajasekhar, MD

CONTACT

support@mydailydoctor.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 8, 2022
• Study Start: April 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)