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

Hypertension Clinical Trial

Official title:

PILOT: Effectiveness of BP Remote Monitoring Software With Virtual Physician Management in Stage 2 Hypertension Patients With History of Stroke or TIA.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05319418
• Other study ID #: 61821
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Est. completion date: March 2023

Study information

• Verified date: April 2022
• Source: AIRx Health, Inc.
• Contact: Michelle Howard
• Phone: (408) 837-2211
• Email: support[@]mydailydoctor.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Stroke (CVA) or TIA

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Stroke Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
AIRx Health, Inc.	Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (8)

Achelrod D, Schreyögg 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2006 Jun 14. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	24 Weeks
Secondary	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.	Every 4-week period over 24 weeks.
Secondary	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)	Varies, recorded over 24 weeks
Secondary	Participant compliance	Participant compliance, defined as the percentage of days that a patient transmits a vital sign reading on a monthly or weekly basis.	Recorded over 24 weeks
Secondary	Rate of blood pressure decline	Rate of blood pressure decline	Recorded over 24 weeks
Secondary	Change in number of antihypertensive drugs	Change in number of antihypertensive drugs prescribed between baseline and the final assessment	24 Weeks
Secondary	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, ß-blockers, and others (a-blockers, hydralazine, minoxidil, clonidine, reserpine, guanethidine, and methyldopa).	24 Weeks
Secondary	Number and types of AEs & SAEs	Number and types of AEs & SAEs	Recorded over 24 weeks
Secondary	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.	Recorded over 24 weeks

External Links

•   Citation 11
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