Clinical trial NCT01099306: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2010-04-06
Enrollment: 199
Sex: ALL
Minimum age (years): 32
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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. :

  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.

Primary outcomes:
measure: Improvements in metabolic syndrome status over the course of this study and absolute mean improvements in individual MS components.
timeFrame: 6 monthS
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: family medicine clinic JUH
Study officials:
affiliation: University of Jordan/ Faculty of Pharmacy
name: Eman Hammad, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Jordan/ Faculty of Pharmacy
name: Abla Al bsoul, PhD
role: STUDY_DIRECTOR
References: