Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 8:57 PM
Study NCT ID:
NCT04275934
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2020-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Pressure First Medication Therapy Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001794', 'term': 'Blood Pressure'}], 'ancestors': [{'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-18', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure Control', 'timeFrame': '6-months', 'description': 'Management of Systolic and Diastolic Blood Pressure Measures'}, {'measure': 'Blood Pressure Change', 'timeFrame': '6-months', 'description': 'Systolic and Diastolic Blood Pressure Measure Changes'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure Medication Adherence', 'timeFrame': '6-months', 'description': 'Medication Adherence for Blood Pressure Medications as Measured by Proportion of Days Covered (PDC)'}, {'measure': 'Health Care Utilization of Primary Care Services', 'timeFrame': '6-months', 'description': 'Evaluation of Pre- and Post-Intervention Frequency of Primary Health Care Visits'}, {'measure': 'Health Care Utilization of Emergency Department Services', 'timeFrame': '6-months', 'description': 'Evaluation of Pre- and Post-Intervention Frequency Emergency Department Visits'}, {'measure': 'Health Care Utilization of Hospital Services', 'timeFrame': '6-months', 'description': 'Evaluation of Pre- and Post-Intervention Frequency of Hospital Visits'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Blood Pressure', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The primary objective of this project is to improve the health status of participants through pharmacist-delivered blood pressure control programs that demonstrate value to employers and justify adoption, sustainability and scalability of these programs.', 'detailedDescription': 'Univariate comparisons of the baseline/pre-intervention outcomes to the post-intervention outcomes will be performed on outcomes in order to determine how the intervention affects each. For continuous outcomes data the univariate comparisons of the pre-treatment and post-intervention outcomes will be performed using related samples t-test comparisons. For categorical outcomes data, comparisons of pre-intervention to post-intervention time frames will be performed using McNemar tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Beneficiaries of self-insured employer who may benefit from patient-centered, team-based care that supports blood pressure control.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All health plan beneficiaries 18 years-of-age and older\n* Have filled at least one blood pressure medication in the last three months,\n* Have a known hypertension diagnosis or have an uncontrolled blood pressure\n\nExclusion Criteria:\n\n* Not an adult\n* Not a health plan beneficiary of the self-insured employer\n* Not ambulatory and able to work or participate in care visits'}, 'identificationModule': {'nctId': 'NCT04275934', 'acronym': 'BP First', 'briefTitle': 'Blood Pressure First Medication Therapy Management', 'organization': {'class': 'OTHER', 'fullName': 'American Pharmacists Association Foundation'}, 'officialTitle': 'Evaluation of the Impact of Self-insured Employer Implementation of an Innovative Care Model Utilizing Pharmacist-delivered MTM Services for Health Plan Beneficiaries With High Blood Pressure', 'orgStudyIdInfo': {'id': '020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort', 'description': 'This project will evaluate the impact of self-insured employers implementing an innovative care model utilizing pharmacist-delivered MTM services for health plan beneficiaries with high blood pressure.', 'interventionNames': ['Behavioral: Health Management; Blood Pressure']}], 'interventions': [{'name': 'Health Management; Blood Pressure', 'type': 'BEHAVIORAL', 'description': "Pharmacists will work with the patient/study subject, referred to as the participant hereafter, and the participant's other health care providers to manage their blood pressure, making recommendations for medication and lifestyle adjustments as needed.", 'armGroupLabels': ['Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30188', 'city': 'Woodstock', 'state': 'Georgia', 'country': 'United States', 'facility': 'Woodstock Pharmaceutical & Compounding Center Inc.', 'geoPoint': {'lat': 34.10149, 'lon': -84.51938}}], 'overallOfficials': [{'name': 'Benjamin M Bluml, RPh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APhA Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Pharmacists Association Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}