Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT06113458
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-06
First Post:
2023-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Hypertension Remote Monitoring Evaluation Redesign
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2023-10-27', 'studyFirstSubmitQcDate': '2023-10-27', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in systolic BP (clinic)', 'timeFrame': 'Baseline, 6 months', 'description': 'Clinic-based BP readings in EHR'}], 'secondaryOutcomes': [{'measure': 'Change in systolic BP (home)', 'timeFrame': 'Baseline, 6 months', 'description': 'Home-based BP readings'}, {'measure': 'Patient activation and satisfaction', 'timeFrame': 'Baseline, 6 months', 'description': 'Patients will complete the Patient Assessment of Chronic Illness Care (PACIC) survey of 20 questions regarding elements of the care of their chronic condition(s) over the last six months. Patients answer using a Likert scale of answers ranging from 1-5, with 1 signifying "Almost Never" and 5 signifying "Almost Always".'}, {'measure': 'Number of participants with BP control', 'timeFrame': 'Baseline, 6 months', 'description': '\\<140/90mmHg, at the patient level within the EHR'}, {'measure': 'Medication intensification when BP is uncontrolled', 'timeFrame': 'Baseline, 6 months', 'description': 'Number of classes of anti-hypertensive medications prescribed per patient'}, {'measure': 'Patient-reported medication adherence', 'timeFrame': 'Baseline, 6 months', 'description': 'Patients will complete the 4-item Krousel-Wood Medication Adherence Scale (M-Wood-MAS-4). The scale score is calculated by summing the points for the 4 questions (scale score ranges from 0 to 4, with higher score indicating worse adherence); low adherence on the K-Wood-MAS-4 is defined as a score ≥1.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '40086748', 'type': 'DERIVED', 'citation': 'Lyles CR, Khoong EC, Stern RJ, Abtahi N, Sharma AE, Pletcher MJ, Xia F, Garcia F, Shah ND, Tieu L, Sarkar U; CHARMED consortium. Championing Hypertension Remote Monitoring for Equity and Dissemination (CHARMED): A multi-site factorial randomized controlled trial protocol. Contemp Clin Trials. 2025 May;152:107879. doi: 10.1016/j.cct.2025.107879. Epub 2025 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effectiveness of evidence-based, adapted, and tailored, patient-focused and clinic-focused strategies to improve blood pressure (BP) control in English- and Spanish-speaking patients with hypertension (HTN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Any sex/gender\n* Any race or ethnicity\n* Have hypertension or high blood pressure (BP) (BP \\>=140/90 mmHg at least twice in the previous 18 months)\n* Can read and write English or Spanish\n* Be able to provide consent\n\nExclusion Criteria:\n\n• We will exclude individuals with conditions that might have severe self-management limitations due to a disability or medical condition or might complicate remote BP monitoring, such as self-reported:\n\n* Pregnancy\n* Lactating/nursing\n* Dialysis'}, 'identificationModule': {'nctId': 'NCT06113458', 'acronym': 'CHARMED', 'briefTitle': 'Comparing Hypertension Remote Monitoring Evaluation Redesign', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Comparing Hypertension Remote Monitoring Evaluation Redesign', 'orgStudyIdInfo': {'id': 'P0564385'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard and One-time Training', 'description': 'Patient level: Standard, automatic reminders Clinic level: One-time training', 'interventionNames': ['Behavioral: Standard and One-time Training']}, {'type': 'EXPERIMENTAL', 'label': 'Standard and Practice Facilitation', 'description': 'Patient level: Standard, automatic reminders Clinic level: Regular, ongoing coaching', 'interventionNames': ['Behavioral: Standard and Practice Facilitation']}, {'type': 'EXPERIMENTAL', 'label': 'High-intensity and One-time Training', 'description': 'Patient level: Personalized feedback Clinic level: One-time training', 'interventionNames': ['Behavioral: High-intensity and One-time Training']}, {'type': 'EXPERIMENTAL', 'label': 'High-intensity and Practice Facilitation', 'description': 'Patient level: Personalized feedback Clinic level: Regular, ongoing coaching', 'interventionNames': ['Behavioral: High-intensity and Practice Facilitation']}], 'interventions': [{'name': 'Standard and One-time Training', 'type': 'BEHAVIORAL', 'description': 'Patient-level intervention: Patients in the standard group will receive automated reminder SMS text messages and remote BP monitoring.\n\nClinic-level intervention: Clinics in the one-time training group will receive one-time training on standard work and algorithms, audit and feedback, and panel-based outreach.', 'armGroupLabels': ['Standard and One-time Training']}, {'name': 'Standard and Practice Facilitation', 'type': 'BEHAVIORAL', 'description': 'Patient-level intervention: Patients in the standard group will receive automated reminder SMS text messages and remote BP monitoring.\n\nClinic-level intervention: Clinics in the practice facilitation group will receive regular/ongoing training on standard work and algorithms, audit and feedback, and panel-based outreach.', 'armGroupLabels': ['Standard and Practice Facilitation']}, {'name': 'High-intensity and One-time Training', 'type': 'BEHAVIORAL', 'description': 'Patient-level intervention: Patients in the high-intensity group will receive personalized feedback SMS text messages and remote BP monitoring.\n\nClinic-level intervention: Clinics in the one-time training group will receive one-time training on standard work and algorithms, audit and feedback, and panel-based outreach.', 'armGroupLabels': ['High-intensity and One-time Training']}, {'name': 'High-intensity and Practice Facilitation', 'type': 'BEHAVIORAL', 'description': 'Patient-level intervention: Patients in the high-intensity group will receive personalized feedback SMS text messages and remote BP monitoring.\n\nClinic-level intervention: Clinics in the practice facilitation group will receive regular/ongoing training on standard work and algorithms, audit and feedback, and panel-based outreach.', 'armGroupLabels': ['High-intensity and Practice Facilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Zuckerberg San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Urmimala Sarkar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}