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Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by:
University of Jordan
ClinicalTrials.gov Identifier:
NCT01099306
First received: April 5, 2010
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Metabolic Syndrome
 Other: Pharmaceutical care services

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
Official Title: Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Jordan:

Primary Outcome Measures:
  • Improvements in metabolic syndrome status over the course of this study and absolute mean improvements in individual MS components. [ Time Frame: 6 monthS ] [ Designated as safety issue: No ]

    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.


Enrollment: 199
Study Start Date: March 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   32 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01099306

Locations
Jordan
family medicine clinic JUH
Amman, Jordan, 13046
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Eman Hammad, faculty of pharmacy / University of Jordan
ClinicalTrials.gov Identifier: NCT01099306     History of Changes
Other Study ID Numbers: JUaym8071383
Study First Received: April 5, 2010
Last Updated: April 5, 2010
Health Authority: Jordan: Jordan Food and Drug Administration (JFDA)

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013