Clinical Pharmacists Role in the Management of Hypertension in Jordan
Primary Purpose
Hypertension
Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
pharmaceutical care services
Sponsored by

About this trial
This is an interventional health services research trial for Hypertension focused on measuring Uncontrolled blood pressure
Eligibility Criteria
Inclusion Criteria:
- Patients with uncontrolled BP, receiving 0-3 antihypertensive drugs with no change in the regimen or dose within the past 3 month.
Exclusion Criteria:
- Patients with hypertensive urgency or emergency with BP more than (180/110).
- Patients with recent stroke or myocardial infraction (within past 6 months).
- Patients with Class III or IV Chronic heart Failure (CHF).
- Patients with Unstable angina.
- Patients with Serious renal or hepatic disease.
- Pregnant patients.
- Patients with Dementia or cognitive impairment.
- If the patient is unable to provide informed written consent.
Sites / Locations
- family medicine clinic JUH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
intervention group
control
Arm Description
physician-pharmacist teamwork
physician only team
Outcomes
Primary Outcome Measures
percentage of patients who achieved blood pressure goals specified by the JNC VII at each group
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.
Secondary Outcome Measures
mean reductions in both systolic and diastolic blood pressure readings
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
Full Information
NCT ID
NCT01079494
First Posted
March 2, 2010
Last Updated
April 6, 2010
Sponsor
University of Jordan
Collaborators
Jordan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01079494
Brief Title
Clinical Pharmacists Role in the Management of Hypertension in Jordan
Official Title
Clinical Pharmacists Role in the Management of Hypertension in Jordan
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Jordan
Collaborators
Jordan Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
Interventions: 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Uncontrolled blood pressure
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
266 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
physician-pharmacist teamwork
Arm Title
control
Arm Type
No Intervention
Arm Description
physician only team
Intervention Type
Other
Intervention Name(s)
pharmaceutical care services
Intervention Description
Patients treatment related problems and therapeutic needs or complains identified by clinical pharmacist and managed collaboratively by both pharmacist and the physician.
Primary Outcome Measure Information:
Title
percentage of patients who achieved blood pressure goals specified by the JNC VII at each group
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.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
mean reductions in both systolic and diastolic blood pressure readings
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with uncontrolled BP, receiving 0-3 antihypertensive drugs with no change in the regimen or dose within the past 3 month.
Exclusion Criteria:
Patients with hypertensive urgency or emergency with BP more than (180/110).
Patients with recent stroke or myocardial infraction (within past 6 months).
Patients with Class III or IV Chronic heart Failure (CHF).
Patients with Unstable angina.
Patients with Serious renal or hepatic disease.
Pregnant patients.
Patients with Dementia or cognitive impairment.
If the patient is unable to provide informed written consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Hammad, MSc
Organizational Affiliation
University of Jordan/ Faculty of Pharmacy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abla Al bsoul, PhD
Organizational Affiliation
University of Jordan/ Faculty of Pharmacy
Official's Role
Study Director
Facility Information:
Facility Name
family medicine clinic JUH
City
Amman
ZIP/Postal Code
13046
Country
Jordan
12. IPD Sharing Statement
Learn more about this trial
Clinical Pharmacists Role in the Management of Hypertension in Jordan
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