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

April 5, 2010
April 5, 2010
March 2009
November 2009   (final data collection date for 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 ] [ 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.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome
Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
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.
  • Active Comparator: intervention
    pharmacist-physician collaborative approach to manage Metabolic syndrome
    Intervention: Other: Pharmaceutical care services
  • No Intervention: control
    physician only team to manage Metabolic syndrome
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
199
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
32 Years to 88 Years
No
Contact information is only displayed when the study is recruiting subjects
Jordan
 
NCT01099306
JUaym8071383
Yes
Eman Hammad, faculty of pharmacy / University of Jordan
University of Jordan
Not Provided
Principal Investigator: Eman Hammad, MSc University of Jordan/ Faculty of Pharmacy
Study Director: Abla Al bsoul, PhD University of Jordan/ Faculty of Pharmacy
University of Jordan
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP