Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-25 @ 2:16 PM
Study NCT ID:
NCT06712966
Status:
WITHDRAWN
Last Update Posted:
2025-04-07
First Post:
2024-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EngageRx With Integrated Self-Measurement of Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm interventional study with comparison to historical controls'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study deemed not human subjects research and will proceed as quality improvement.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2024-11-27', 'lastUpdatePostDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Net Promoter Score', 'timeFrame': '3 months', 'description': 'This score is assessed by asking a single question about likelihood of recommending the device to a friend, with options from 1-10 (10 being extremely likely). As per published methods, persons indicating 9 or 10 are considered "Promoters"; persons indicating 7 or 8 are "Passives"; and persons indicating 1-6 are "Detractors". The score is calculated by taking the percent of Promoters and subtracting the percent of Detractors, yielding a score for each group ranging from -100 to 100.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '24788496', 'type': 'BACKGROUND', 'citation': 'Hamilton DF, Lane JV, Gaston P, Patton JT, Macdonald DJ, Simpson AH, Howie CR. Assessing treatment outcomes using a single question: the net promoter score. Bone Joint J. 2014 May;96-B(5):622-8. doi: 10.1302/0301-620X.96B5.32434.'}, {'pmid': '25345554', 'type': 'BACKGROUND', 'citation': 'Krol MW, de Boer D, Delnoij DM, Rademakers JJ. The Net Promoter Score--an asset to patient experience surveys? Health Expect. 2015 Dec;18(6):3099-109. doi: 10.1111/hex.12297. Epub 2014 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study will support use of EngageRx\\_SMBP for 70 patients in the UCSF General Internal Medicine practice. The goals of the pilot will be to assess usability and satisfaction of both patients and clinicians, and to describe BP-related process metrics and outcomes including time to intensification of BP medications and/or BP control.', 'detailedDescription': 'EngageRx is a programmable clinical decision support app that clinicians can access within the context of their electronic health record (EHR), and it can be connected with other technologies. We are integrating EngageRx with CareSimple, a company that provides a cellular-enabled BP device that patients can use for SMBP. CareSimple devices are FDA-cleared, can be shipped directly to patients, used by patients right out of the box (after installing batteries), and then deliver the SMBP measurements directly to the CareSimple cloud platform. There is no requirement to "sync" the device, and no need for patients to have a smartphone or set up an account or sign into anything. CareSimple supports a dashboard and portal that allows authorized users to sign in and access measurements for a patient, but this amounts to another barrier for clinicians to access the measurements; our integration with EngageRx will 1) allow clinicians to initiate SMBP monitoring for a patient with the click of a button (after confirming their shipping address and preferred language); 2) automatically register the patient in the CareSimple system, which triggers CareSimple to mail the patient the BP monitor device with instructions; and 3) automatically push the CareSimple SMBP measurements to EngageRx so they are available the next time the clinician opens EngageRx. The SMBP measurements will be used with EngageRx\'s internal algorithm, along with office BP measurements, to recommend BP management decisions to clinicians. We believe this integrated system, which we will refer to as EngageRx\\_SMBP, will make SMBP easy for clinicians and patients. We would like to determine if this system is truly easy to use for clinicians and providers, and whether it appears to facilitate the BP-related processes of care required for controlling hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (18+ years old) with uncontrolled BP in an office visit\n* Lowest SBP\\>140 or lowest DBP\\>90 during the visit at one of the Mt. Zion General Internal Medicine practices\n* Speaks English or Spanish\n\nExclusion Criteria:\n\n* If patient is unlikely to be able to use a home BP monitor\n* Cannot understand the verbal consent'}, 'identificationModule': {'nctId': 'NCT06712966', 'briefTitle': 'EngageRx With Integrated Self-Measurement of Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'EngageRx With Integrated Self-Measurement of Blood Pressure', 'orgStudyIdInfo': {'id': '24-42835'}, 'secondaryIdInfos': [{'id': '1R43DP006817-01', 'link': 'https://reporter.nih.gov/quickSearch/1R43DP006817-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EngageRx_SMBP', 'description': 'Integrated SMBP monitoring using EngageRx\\_SMBP.', 'interventionNames': ['Other: EngageRx_SMBP']}], 'interventions': [{'name': 'EngageRx_SMBP', 'type': 'OTHER', 'description': "Patients in the EngageRx\\_SMBP arm will be automatically registered in the CareSimple system and mailed a device they can use at home. They may also choose to install a smartphone application from CareSimple that will provide reminders about measuring their BP. The clinician will then manage the patient's hypertension according to the standard of care. The SMBP measurements from CareSimple will be available through EngageRx for them to use, and they will receive a weekly staff message to check EngageRx if there are new SMBP measurements for them to review. The clinician will also be able to indicate when they would like to stop using the CareSimple system.", 'armGroupLabels': ['EngageRx_SMBP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Mark Pletcher, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'New York University', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}