HypertensionNCT01079494
Clinical Pharmacists Role in the Management of Hypertension in Jordan
A study testing pharmaceutical care services in people with Hypertension, run by University of Jordan at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 88 years
- Conditions the study is for
- Hypertension
- What is being tested?
- pharmaceutical care services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteJordan
- Study dates
- Mar 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with uncontrolled BP, receiving 0-3 antihypertensive drugs with no change in the regimen or dose within the past 3 month.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- pharmaceutical care services
- Keywords
- Uncontrolled blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaceutical care servicesOther
Patients treatment related problems and therapeutic needs or complains identified by clinical pharmacist and managed collaboratively by both pharmacist and the physician.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | physician-pharmacist teamwork Receives: Other: pharmaceutical care services |
| control | No intervention | physician only team |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMar 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan Hospital
- Investigators
- Eman Hammad, MSc, Principal investigator, University of Jordan/ Faculty of PharmacyAbla Al bsoul, PhD, Study director, University of Jordan/ Faculty of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079494
- Sponsor's protocol ID
- JU8071383
- Status last verified
- Mar 2009
- First submitted
- 2 Mar 2010
- Last updated
- 7 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacists Role in the Management of Hypertension in Jordan
- ClinicalTrials.gov ID
- NCT01079494
- Acronym / sponsor ID
- JU8071383
- Conditions
- Hypertension
- Keywords
- Uncontrolled blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Collaborators
- Jordan Hospital
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Other: pharmaceutical care servicesphysician-pharmacist teamwork |
| control | No intervention | –physician only team |
Who may qualify
- Ages
- 21 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with uncontrolled BP, receiving 0-3 antihypertensive drugs with no change in the regimen or dose within the past 3 month.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmaceutical care servicesPatients treatment related problems and therapeutic needs or complains identified by clinical pharmacist and managed collaboratively by both pharmacist and the physician. | Other | intervention group |
Primary outcome
percentage of patients who achieved blood pressure goals specified by the JNC VII at each group
Time frame: 6 month
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.
1 secondary outcome
mean reductions in both systolic and diastolic blood pressure readings
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Hammad, MSc principal investigator
University of Jordan/ Faculty of Pharmacy
Abla Al bsoul, PhD study director
University of Jordan/ Faculty of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmaceutical care services in people with Hypertension, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients who achieved blood pressure goals specified by the JNC VII at each group (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2010.