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Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Pharmaceutical care services
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Metabolic Syndrome

Eligibility Criteria

32 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • family medicine clinic JUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

intervention

control

Arm Description

pharmacist-physician collaborative approach to manage Metabolic syndrome

physician only team to manage Metabolic syndrome

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2010
Last Updated
April 5, 2010
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT01099306
Brief Title
Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome
Official Title
Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Jordan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Active Comparator
Arm Description
pharmacist-physician collaborative approach to manage Metabolic syndrome
Arm Title
control
Arm Type
No Intervention
Arm Description
physician only team to manage Metabolic syndrome
Intervention Type
Other
Intervention Name(s)
Pharmaceutical care services
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvements in metabolic syndrome status over the course of this study and absolute mean improvements in individual MS components.
Description
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.
Time Frame
6 monthS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility 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. : Abdominal circumference >102 cm in males or >88 cm in females. HDL cholesterol < 40 mg/dl for males or < 50 mg/dl for females. Triglycerides ≥ 150 mg/dl. Blood pressure ≥ 130/85 mmHg or receiving hypertension treatment. Baseline glycemia ≥ 110 mg/dl. Exclusion Criteria: Patients with hypertensive urgency or emergency with BP more than (180/110). Patients with recent stroke or myocardial infraction (within past 6 months). Patients with Class III or IV Chronic heart Failure (CHF). Patients with Unstable angina. Patients with Serious renal or hepatic disease. Pregnant patients. Patients with Dementia or cognitive impairment. If the patient is unable to provide informed written consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Hammad, MSc
Organizational Affiliation
University of Jordan/ Faculty of Pharmacy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abla Al bsoul, PhD
Organizational Affiliation
University of Jordan/ Faculty of Pharmacy
Official's Role
Study Director
Facility Information:
Facility Name
family medicine clinic JUH
City
Amman
ZIP/Postal Code
13046
Country
Jordan

12. IPD Sharing Statement

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Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

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