Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 5:53 AM
Study NCT ID:
NCT07413159
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The "Check, Monitor, Control Hypertension" Study is a 24-month Randomized Trial in Houston Targeting African Americans Aged 55+. It Combines Pharmacist Counseling and CHW Support to Improve Blood Pressure Control in Hypertension Management.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D010595', 'term': 'Pharmacists'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study uses an interventional study model called a randomized Parallel design. Participants (n=480) will be randomly assigned to one of two intervention groups:\n\nPharmacist-only intervention Pharmacist + Community Health Worker (CHW) intervention\n\nThe allocation is randomized, and the model includes masking for outcomes assessment. The interventions are behavioral (medication therapy management, lifestyle counseling, and CHW-led workshops) rather than drug or device-based.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months, 24 months', 'description': 'Mean change in systolic blood pressure (mmHg) from baseline to 24 months, measured using standardized BP readings.'}], 'secondaryOutcomes': [{'measure': 'Change in Diastolic Blood Pressure', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months, 24 months', 'description': 'Mean change in diastolic BP from baseline to 24 months.'}, {'measure': 'Medication Adherence', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months, 24 months', 'description': 'Proportion of participants adhering to prescribed antihypertensive medications, assessed via self-report.'}, {'measure': 'Lifestyle Behavior Changes', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Changes in diet, physical activity, and assessed via validated questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The proposed study, "Check, Monitor, Control Hypertension in Older African American Adults," is a randomized clinical trial designed to improve blood pressure control among African American adults aged 55 years and older in the Greater Houston area. Hypertension disproportionately affects African Americans, contributing to higher rates of cardiovascular disease and stroke. This project aims to improve clinical and behavioral outcomes through a 24-month intervention combining pharmacist-led counseling and Community Health Worker (CHW) support.', 'detailedDescription': 'Hypertension (high blood pressure) is a major health concern in the United States, especially among African Americans, who experience higher rates of uncontrolled blood pressure and related complications like heart disease and stroke. This study aims to improve blood pressure control in older African American adults through a community-based approach that combines pharmacist-led counseling and Community Health Worker (CHW) support.\n\nThe study will enroll 480 African American adults aged 55 and older living in the Greater Houston area who have a history of hypertension. Participants will be randomly assigned to one of two groups: Pharmacist-only intervention - Participants receive medication therapy management and education on blood pressure monitoring and lifestyle changes; Pharmacist + CHW intervention - In addition to pharmacist counseling, participants receive personalized support from a CHW to overcome barriers like transportation and food insecurity, plus eight group health workshops each year. Both groups will receive a digital blood pressure monitor and guidance on checking blood pressure at home.\n\nThis matters because African Americans face unique challenges in managing hypertension, including contextual factors and limited access to care. By combining medical expertise with community-based support, this study hopes to empower participants to take control of their health and improve hypertension outcomes.\n\nTimeline \\& Safety\n\nRecruitment begins: January 2026 Intervention duration: 24 months Primary completion date: May 2030 The study poses minimal risk, mainly mild discomfort from blood pressure checks. Privacy will be protected using HIPAA-compliant systems, and participation is voluntary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals are eligible to the study if they are:\n\n* 55 years or older\n* Have at least 2 high blood pressure readings ≥ 130/80 mmHg within one month\n* Past Medical History of hypertension \\> 1 year\n* Taking at least 1 antihypertensive medication\n* Independent Activities of Daily Livings (ADL) and instrumental Activities of Daily Livings (iADL)\n* Have a SmartPhone\n* Live within the Greater Houston Metropolitan Areas\n* Able to speak English\n\nExclusion criteria:\n\n* Unable to verbalize comprehension of study or impaired cognitive function (e.g. dementia)\n* Not able to monitor blood pressure at home\n* Plans to relocate outside Houston within the next year'}, 'identificationModule': {'nctId': 'NCT07413159', 'briefTitle': 'The "Check, Monitor, Control Hypertension" Study is a 24-month Randomized Trial in Houston Targeting African Americans Aged 55+. It Combines Pharmacist Counseling and CHW Support to Improve Blood Pressure Control in Hypertension Management.', 'organization': {'class': 'OTHER', 'fullName': 'Texas Southern University'}, 'officialTitle': 'Check, Monitor, Control Hypertension in Older African American Adults (#Check, Monitor, Control)', 'orgStudyIdInfo': {'id': '6310'}, 'secondaryIdInfos': [{'id': '2U54MD007605-32', 'link': 'https://reporter.nih.gov/quickSearch/2U54MD007605-32', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pharmacist Only (Control Group)', 'description': 'Participants receive usual hypertension care as per standard practice provided by a clinical pharmacists', 'interventionNames': ['Other: Pharmacists Only (Control Group)']}, {'type': 'EXPERIMENTAL', 'label': 'Combined Intervention (Pharmacists + CHW Interventions)', 'description': 'Participants receive both Pharmacist and CHW Counseling and Support', 'interventionNames': ['Other: Combined Intervention (Pharmacists + CHW Interventions)']}], 'interventions': [{'name': 'Pharmacists Only (Control Group)', 'type': 'OTHER', 'description': 'Medication management and disease state counseling provided by a clinical pharmacist.', 'armGroupLabels': ['Pharmacist Only (Control Group)']}, {'name': 'Combined Intervention (Pharmacists + CHW Interventions)', 'type': 'OTHER', 'description': 'Participants receive CHW Individual patient assistance and group health workshops in addition to pharmacist interventions', 'armGroupLabels': ['Combined Intervention (Pharmacists + CHW Interventions)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ivy 0 Poon, Pharm.D., M.S., BCPS', 'role': 'CONTACT', 'email': 'ivy.poon@tsu.edu', 'phone': '713-313-4400'}, {'name': 'Creaque C Tyler, PharmD, BCGP', 'role': 'CONTACT', 'email': 'creaque.charles@tsu.edu'}], 'facility': '3100 Cleburne Street, Nabrit Science Building,', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Ivy 0 Poon, Pharm.D., M.S., BCPS', 'role': 'CONTACT', 'email': 'ivy.poon@tsu.edu', 'phone': '713-313-4400'}, {'name': 'Creaque C Tyler, PharmD, BCGP', 'role': 'CONTACT', 'email': 'creaque.charles@tsu.edu'}], 'overallOfficials': [{'name': 'Ivy O Poon, Pharm.D., M.S., BCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Southern University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available beginning 12 months after publication of primary results and will remain accessible for at least 5 years.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) will be shared, including:\n\nBaseline demographic and clinical characteristics Intervention adherence data Primary and secondary outcome measures (e.g., blood pressure readings, medication adherence, lifestyle behavior changes)', 'accessCriteria': 'Researchers must submit a data use request and agree to a data use agreement. Data will be shared through an NIH-approved repository (e.g., dbGaP or similar secure platform).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Southern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}