Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: Pharmaceutical care services

• Registration Number: NCT01099306
• Lead Sponsor: University of Jordan

Brief 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. 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 Timeline

• Status Verified: 2009-03
• Study Start: 2009-03
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2010-04-05
• Study First Submitted QC: 2010-04-05
• Last Update Submitted: 2010-04-05
• Study First Posted: 2010-04-06
• Last Update Posted: 2010-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Pharmaceutical care services	pharmacist-physician collaborative approach to manage Metabolic syndrome

Primary Outcome Measures

Name	Time	Method
Improvements in metabolic syndrome status over the course of this study and absolute mean improvements in individual MS components.	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.

Trial Locations

Locations (1)

family medicine clinic JUH; 🇯🇴 Amman, Jordan