Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-03-06 @ 10:55 PM
Study NCT ID:
NCT05319418
Status:
UNKNOWN
Last Update Posted:
2022-04-08
First Post:
2022-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of BP Remote Monitoring With Virtual Physician Management in Hypertensive Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-01', 'studyFirstSubmitDate': '2022-04-01', 'studyFirstSubmitQcDate': '2022-04-01', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent patients within target BP', 'timeFrame': '24 Weeks', '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'}], 'secondaryOutcomes': [{'measure': 'Change in average systolic blood pressure', 'timeFrame': '24 Weeks', '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.'}, {'measure': 'Proportion of patients within target BP range', 'timeFrame': 'Every 4-week period over 24 weeks.', 'description': 'Proportions of patients who are within their target blood pressure range during every 4-week period over 24 weeks.'}, {'measure': 'Time taken to achieve a clinically significant reduction in blood pressure', 'timeFrame': 'Varies, recorded over 24 weeks', '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)'}, {'measure': 'Participant compliance', 'timeFrame': 'Recorded over 24 weeks', 'description': 'Participant compliance, defined as the percentage of days that a patient transmits a vital sign reading on a monthly or weekly basis.'}, {'measure': 'Rate of blood pressure decline', 'timeFrame': 'Recorded over 24 weeks', 'description': 'Rate of blood pressure decline'}, {'measure': 'Change in number of antihypertensive drugs', 'timeFrame': '24 Weeks', 'description': 'Change in number of antihypertensive drugs prescribed between baseline and the final assessment'}, {'measure': 'Change in number of classes of antihypertensive drugs', 'timeFrame': '24 Weeks', '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).'}, {'measure': 'Number and types of AEs & SAEs', 'timeFrame': 'Recorded over 24 weeks', 'description': 'Number and types of AEs \\& SAEs'}, {'measure': 'Proportions of patients of various BP categories', 'timeFrame': 'Recorded over 24 weeks', 'description': 'Based on weekly and 4-weekly blood pressure averages, the proportions of patients who are classified as:\n\nNormal (\\<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.\n\nStage 2 hypertensive: systolic pressure ≥140 mm Hg or a diastolic pressure ≥90 mm Hg.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['remote patient monitoring', 'digital health monitoring', 'blood pressure monitoring'], 'conditions': ['Hypertension', 'Stroke (CVA) or TIA']}, 'referencesModule': {'references': [{'pmid': '31355878', 'type': 'BACKGROUND', '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.'}, {'pmid': '25873044', 'type': 'BACKGROUND', '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.'}, {'pmid': '26551272', 'type': 'BACKGROUND', '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.'}, {'pmid': '27029815', 'type': 'BACKGROUND', '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.'}, {'pmid': '27699567', 'type': 'BACKGROUND', '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.'}, {'pmid': '31581801', 'type': 'BACKGROUND', '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.'}, {'pmid': '17765133', 'type': 'BACKGROUND', '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.'}, {'pmid': '17699300', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'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', 'label': 'Citation 14'}, {'url': 'https://cardio.jmir.org/2019/1/e130/', 'label': 'Citation 11'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nTo 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 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).\n\nAt 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).\n\nThe referring physician feels the patient would benefit from BP optimization. Consent to receive care from telehealth physicians available through the DailyDoctor monitoring platform.\n\nEnglish or Spanish speaking.\n\nExclusion Criteria:\n\nCurrently 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.\n\nBlood pressure reduction is not indicated (e.g. patients who have a high blood pressure target to augment cerebral perfusion).\n\nAny other reason that, in the opinion of the investigator, makes the person a poor candidate for participation in this study'}, 'identificationModule': {'nctId': 'NCT05319418', 'briefTitle': 'Effectiveness of BP Remote Monitoring With Virtual Physician Management in Hypertensive Patients.', 'organization': {'class': 'OTHER', 'fullName': 'AIRx Health, Inc.'}, 'officialTitle': 'PILOT: Effectiveness of BP Remote Monitoring Software With Virtual Physician Management in Stage 2 Hypertension Patients With History of Stroke or TIA.', 'orgStudyIdInfo': {'id': '61821'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypertensive Patients Monitored Daily', '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.', 'interventionNames': ['Behavioral: Daily Blood Pressure Monitoring']}], 'interventions': [{'name': 'Daily Blood Pressure Monitoring', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Hypertensive Patients Monitored Daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Lironn Kraler, MD', 'role': 'CONTACT', 'email': 'lkraler@stanford.edu'}, {'name': 'Maarten Lansberg, MD PhD', 'role': 'CONTACT', 'email': 'lansberg@stanford.edu'}, {'name': 'Lironn Kraler, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Stanford Stroke Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Michelle Howard', 'role': 'CONTACT', 'email': 'support@mydailydoctor.com', 'phone': '(408) 837-2211'}, {'name': 'Vijay Rajasekhar, MD', 'role': 'CONTACT', 'email': 'support@mydailydoctor.com'}], 'overallOfficials': [{'name': 'Maarten Lansberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AIRx Health, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}