Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

NCT01099306 | Completed DMC

• 1 other identifier: JUaym8071383
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

intervention

ACTIVE COMPARATOR

pharmacist-physician collaborative approach to manage Metabolic syndrome

Other: Pharmaceutical care services

control

NO INTERVENTION

physician only team to manage Metabolic syndrome

Interventions

Pharmaceutical care services OTHER

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.

intervention

Eligibility Criteria

• Age: 32 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

family medicine clinic JUH

Amman, Amman Governorate, 13046, Jordan

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• Eman Hammad, MSc

  University of Jordan/ Faculty of Pharmacy

  PRINCIPAL INVESTIGATOR

• Abla Al bsoul, PhD

  University of Jordan/ Faculty of Pharmacy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: April 6, 2010
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 6, 2010

Record last verified: 2009-03

Locations

JO (1)