Metabolic SyndromeNCT01099306
Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome
A study testing Pharmaceutical care services in people with Metabolic Syndrome, run by University of Jordan at 1 site in Jordan.
Trial summary
This study devised an experimental focused pharmaceutical care program, allowed a clinical pharmacist to work in a physician office to assess and manage patients' metabolic syndrome status and its individual components. Read more about this study
- Who is it for?
- Ages 32 to 88 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Pharmaceutical care services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 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 32 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting at least 3 of the 5 criteria for the National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATPIII) for the diagnosis of Metabolic syndrome upon the time of enrollment. :
- Abdominal circumference >102 cm in males or >88 cm in females.
- HDL cholesterol < 40 mg/dl for males or < 50 mg/dl for females.
- Triglycerides ≥ 150 mg/dl.
- Blood pressure ≥ 130/85 mmHg or receiving hypertension treatment.
- Baseline glycemia ≥ 110 mg/dl.
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
This study devised an experimental focused pharmaceutical care program, allowed a clinical pharmacist to work in a physician office to assess and manage patients' metabolic syndrome status and its individual components. This study described the clinical benefits of physician- clinical pharmacist interaction in achieving improved glycemic control, lipid and blood pressure measurements, involving medication, diet, physical activity and patient heath care counseling.
Read the detailed description
A single blinded prospective randomized controlled trial conducted in family medicine outpatients clinics in Jordan. The study enrolled 199 patients met the National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATPIII) criteria for the diagnosis of MS upon the time of enrollment. Patients were randomized into: 110 participants into the intervention arm (pharmacist-physician collaborative approach) and 89 into the control arm (physician only team). Only patients in the intervention arm were provided pharmacist recommendations and pharmaceutical care counseling.
- Conditions
- Metabolic Syndrome
- Being tested
- Pharmaceutical care services
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical care servicesOther
Patients' metabolic components were assessed and managed collaboratively by focused care plan designed by the clinical pharmacist and approved by the physician.Pharmacist emphasized the change in lifestyle, particularly weight loss and physical activity as a first line therapy for at least 3 months, patients were started on drug therapy when needed as recommended by clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | pharmacist-physician collaborative approach to manage Metabolic syndrome Receives: Other: Pharmaceutical care services |
| control | No intervention | physician only team to manage Metabolic syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in metabolic syndrome status over the course of this study and absolute mean improvements in individual MS components.
Primary outcomes were specified as:
- Fasting blood glucose < 110 mg/dl.
- Body weight BMI < 25 kg/m2.
- Waist circumference ≤ 102 cm (40 in) in men and ≤ 88 cm (35 inches) in women.
- Serum triglycerides < 150 mg/dl.
- HDL cholesterol ≥40mg/dl in men and ≥50mg/dl in women.
- Blood pressure < 130/85 mm Hg or < 130/80 mm Hg when patients were diabetic.
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 posted6 Apr 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 Metabolic SyndromeStudies 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
- Care provider
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- 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
- NCT01099306
- Sponsor's protocol ID
- JUaym8071383
- Status last verified
- Mar 2009
- First submitted
- 5 Apr 2010
- Last updated
- 6 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01099306
- Acronym / sponsor ID
- JUaym8071383
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 6 Apr 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.
This study devised an experimental focused pharmaceutical care program, allowed a clinical pharmacist to work in a physician office to assess and manage patients' metabolic syndrome status and its individual components. This study described the clinical benefits of physician- clinical pharmacist interaction in achieving improved glycemic control, lipid and blood pressure measurements, involving medication, diet, physical activity and patient heath care counseling.
Detailed description
A single blinded prospective randomized controlled trial conducted in family medicine outpatients clinics in Jordan. The study enrolled 199 patients met the National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATPIII) criteria for the diagnosis of MS upon the time of enrollment. Patients were randomized into: 110 participants into the intervention arm (pharmacist-physician collaborative approach) and 89 into the control arm (physician only team). Only patients in the intervention arm were provided pharmacist recommendations and pharmaceutical care counseling.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Other: Pharmaceutical care servicespharmacist-physician collaborative approach to manage Metabolic syndrome |
| control | No intervention | –physician only team to manage Metabolic syndrome |
Who may qualify
- Ages
- 32 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meeting at least 3 of the 5 criteria for the National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATPIII) for the diagnosis of Metabolic syndrome upon the time of enrollment. :
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' metabolic components were assessed and managed collaboratively by focused care plan designed by the clinical pharmacist and approved by the physician.Pharmacist emphasized the change in lifestyle, particularly weight loss and physical activity as a first line therapy for at least 3 months, patients were started on drug therapy when needed as recommended by clinical guidelines. | Other | intervention |
Primary outcome
Improvements in metabolic syndrome status over the course of this study and absolute mean improvements in individual MS components.
Time frame: 6 monthS
Primary outcomes were specified as: * Fasting blood glucose < 110 mg/dl. * Body weight BMI < 25 kg/m2. * Waist circumference ≤ 102 cm (40 in) in men and ≤ 88 cm (35 inches) in women. * Serum triglycerides < 150 mg/dl. * HDL cholesterol ≥40mg/dl in men and ≥50mg/dl in women. * Blood pressure < 130/85 mm Hg or < 130/80 mm Hg when patients were diabetic.
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 6 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 Metabolic Syndrome, 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 6 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 6 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?
Improvements in metabolic syndrome status over the course of this study and absolute mean improvements in individual MS components. (time frame: 6 monthS). 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 6 Apr 2010.