Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099306
• Other study ID #: JUaym8071383
• Status: Completed
• Phase: N/A
• First received: April 5, 2010
• Last updated: April 5, 2010
• Start date: March 2009
• Est. completion date: November 2009

Study information

• Verified date: March 2009
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Jordan Food and Drug Administration (JFDA)
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 32 Years to 88 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Jordan	family medicine clinic JUH	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 monthS	No