Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 10:56 PM
Study NCT ID:
NCT01079494
Status:
COMPLETED
Last Update Posted:
2010-04-07
First Post:
2010-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Pharmacists Role in the Management of Hypertension in Jordan
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010593', 'term': 'Pharmaceutical Services'}], 'ancestors': [{'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 266}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-06', 'studyFirstSubmitDate': '2010-03-02', 'studyFirstSubmitQcDate': '2010-03-02', 'lastUpdatePostDateStruct': {'date': '2010-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients who achieved blood pressure goals specified by the JNC VII at each group', 'timeFrame': '6 month', 'description': 'defined a goal to be achieved if the systolic blood pressure fell below 140 mm Hg and the diastolic blood pressure fell below 90 mm Hg. Or systolic blood pressure fell below 130 mm Hg and the diastolic blood pressure fell below 80 mm Hg if patient was diabetic.'}], 'secondaryOutcomes': [{'measure': 'mean reductions in both systolic and diastolic blood pressure readings', 'timeFrame': '6 months', 'description': 'mean reductions in systolic blood pressure (Systolic blood pressure at enrollment - Systolic blood pressure last follow up visit) and diastolic BP (Diastolic blood pressure at enrollment - Diastolic blood pressure last follow up visit) for both study groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Uncontrolled blood pressure'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': "Background: studies have demonstrated the crucial role of clinical pharmacists as integrated part of heath care team. Not only in Jordan but also in the Middle East region, clinical pharmacy practice is not well established. This current study is the first to evaluate physicians - pharmacists' collaborative approach to uncontrolled blood pressure in Jordan and the Middle East.", 'detailedDescription': "Objective: this study aimed to evaluate clinical pharmacists' role in the management of uncontrolled hypertensive patients in Jordan. Design: single blinded randomized controlled clinical trial. Patients: 253 patients with uncontrolled hypertension specified as higher blood pressure readings than the recommended goals by the seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure (JNC VII) at the time of enrollment.\n\nInterventions: patients were randomly allocated to an intervention or control group: 130 and 123 patients, respectively. Patients in both arms were followed up for 6 months. In the intervention group, patients were managed by physician-clinical pharmacist team. In the control group, patients were managed by physician(s) only and were not provided pharmaceutical care services."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with uncontrolled BP, receiving 0-3 antihypertensive drugs with no change in the regimen or dose within the past 3 month.\n\nExclusion Criteria:\n\n* Patients with hypertensive urgency or emergency with BP more than (180/110).\n* Patients with recent stroke or myocardial infraction (within past 6 months).\n* Patients with Class III or IV Chronic heart Failure (CHF).\n* Patients with Unstable angina.\n* Patients with Serious renal or hepatic disease.\n* Pregnant patients.\n* Patients with Dementia or cognitive impairment.\n* If the patient is unable to provide informed written consent.'}, 'identificationModule': {'nctId': 'NCT01079494', 'briefTitle': 'Clinical Pharmacists Role in the Management of Hypertension in Jordan', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': 'Clinical Pharmacists Role in the Management of Hypertension in Jordan', 'orgStudyIdInfo': {'id': 'JU8071383'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intervention group', 'description': 'physician-pharmacist teamwork', 'interventionNames': ['Other: pharmaceutical care services']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'physician only team'}], 'interventions': [{'name': 'pharmaceutical care services', 'type': 'OTHER', 'description': 'Patients treatment related problems and therapeutic needs or complains identified by clinical pharmacist and managed collaboratively by both pharmacist and the physician.', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13046', 'city': 'Amman', 'country': 'Jordan', 'facility': 'family medicine clinic JUH', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Eman Hammad, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Jordan/ Faculty of Pharmacy'}, {'name': 'Abla Al bsoul, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Jordan/ Faculty of Pharmacy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jordan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jordan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Eman Hammad', 'oldOrganization': 'faculty of pharmacy / University of Jordan'}}}}