Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

April 5, 2010 updated by: University of Jordan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 13046
        • family medicine clinic JUH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

32 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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. :

    1. Abdominal circumference >102 cm in males or >88 cm in females.
    2. HDL cholesterol < 40 mg/dl for males or < 50 mg/dl for females.
    3. Triglycerides ≥ 150 mg/dl.
    4. Blood pressure ≥ 130/85 mmHg or receiving hypertension treatment.
    5. Baseline glycemia ≥ 110 mg/dl.

Exclusion Criteria:

  1. Patients with hypertensive urgency or emergency with BP more than (180/110).
  2. Patients with recent stroke or myocardial infraction (within past 6 months).
  3. Patients with Class III or IV Chronic heart Failure (CHF).
  4. Patients with Unstable angina.
  5. Patients with Serious renal or hepatic disease.
  6. Pregnant patients.
  7. Patients with Dementia or cognitive impairment.
  8. If the patient is unable to provide informed written consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intervention
pharmacist-physician collaborative approach to manage Metabolic syndrome
Other: Pharmaceutical care services
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.
No Intervention: control
physician only team to manage Metabolic syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 monthS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Investigators

  • Principal Investigator: Eman Hammad, MSc, University of Jordan/ Faculty of Pharmacy
  • Study Director: Abla Al bsoul, PhD, University of Jordan/ Faculty of Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

April 5, 2010

First Submitted That Met QC Criteria

April 5, 2010

First Posted (Estimate)

April 6, 2010

Study Record Updates

Last Update Posted (Estimate)

April 6, 2010

Last Update Submitted That Met QC Criteria

April 5, 2010

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JUaym8071383

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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