HypertensionNCT05319418
Effectiveness of BP Remote Monitoring With Virtual Physician Management in Hypertensive Patients.
A study testing Daily Blood Pressure Monitoring in people with Hypertension and Stroke (CVA) or TIA, run by AIRx Health, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Stroke (CVA) or TIA
- What is being tested?
- Daily Blood Pressure Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Vijay Rajasekhar, MD contact
United States1 site
Stanford Stroke Center
Stanford, California, 94304
Lironn Kraler, MD, lkraler@stanford.edu
Maarten Lansberg, MD PhD, lansberg@stanford.edu
About this study
Official title: PILOT: Effectiveness of BP Remote Monitoring Software With Virtual Physician Management in Stage 2 Hypertension Patients With History of Stroke or TIA.
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.
Read the 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.
- Conditions
- Hypertension, Stroke (CVA) or TIA
- Being tested
- Daily Blood Pressure Monitoring
- Keywords
- remote patient monitoring, digital health monitoring, blood pressure monitoring
- Medical subject headings
- Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Blood Pressure MonitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Daily Blood Pressure Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 Weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Recorded over 24 weeks
Rate of blood pressure decline
Rate of blood pressure decline
Measured: Recorded over 24 weeks
Change in number of antihypertensive drugs
Change in number of antihypertensive drugs prescribed between baseline and the final assessment
Measured: 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).
Measured: 24 Weeks
Number and types of AEs & SAEs
Number and types of AEs \& SAEs
Measured: 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.
Measured: Recorded over 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AIRx Health, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Maarten Lansberg, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319418
- Sponsor's protocol ID
- 61821
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31355878Spruill 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.
PubMed 25873044SPRINT 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.
PubMed 26551272Ho 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.
PubMed 27029815Achelrod 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.
PubMed 27699567Weissman 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.
PubMed 31581801Logan 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.
PubMed 17765133Stevens 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.
PubMed 17699300
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT: Effectiveness of BP Remote Monitoring Software With Virtual Physician Management in Stage 2 Hypertension Patients With History of Stroke or TIA.
- ClinicalTrials.gov ID
- NCT05319418
- Acronym / sponsor ID
- 61821
- Conditions
- Hypertension, Stroke (CVA) or TIA
- Keywords
- remote patient monitoring, digital health monitoring, blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AIRx Health, Inc.University, hospital or other
- Collaborators
- Stanford University
- Study start
- Apr 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive Patients Monitored Daily | Experimental | Behavioral: Daily Blood Pressure MonitoringPhysicians 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Blood Pressure MonitoringPatients 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. | Behavioural | Hypertensive Patients Monitored Daily |
Primary outcome
Percent patients within target BP
Time frame: 24 Weeks
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
9 secondary outcomes
Change in average systolic blood pressure
Time frame: 24 Weeks
Proportion of patients within target BP range
Time frame: Every 4-week period over 24 weeks.
Time taken to achieve a clinically significant reduction in blood pressure
Time frame: Varies, recorded over 24 weeks
Participant compliance
Time frame: Recorded over 24 weeks
Rate of blood pressure decline
Time frame: Recorded over 24 weeks
Change in number of antihypertensive drugs
Time frame: 24 Weeks
Change in number of classes of antihypertensive drugs
Time frame: 24 Weeks
Number and types of AEs & SAEs
Time frame: Recorded over 24 weeks
Proportions of patients of various BP categories
Time frame: Recorded over 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Background: PubMed 31355878Kitagawa 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.
- Background: PubMed 25873044Spruill 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.
- Background: PubMed 26551272SPRINT 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.
- Background: PubMed 27029815Ho 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.
- Background: PubMed 27699567Achelrod 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.
- Background: PubMed 31581801Weissman 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.
- Background: PubMed 17765133Logan 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.
- Background: PubMed 17699300Stevens 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.
- Citation 14Link provided by the sponsor.
- Citation 13Link provided by the sponsor.
- Citation 12Link provided by the sponsor.
- Citation 11Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijay Rajasekhar, MD contact
Maarten Lansberg, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Blood Pressure Monitoring in people with Hypertension and Stroke (CVA) or TIA, run by AIRx Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Howard ((408) 837-2211, support@mydailydoctor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent patients within target BP (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05319418, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.