Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

NCT ID: NCT01099306

Last Updated: 2010-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-11-30

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

Study Groups

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intervention

pharmacist-physician collaborative approach to manage Metabolic syndrome

Group Type ACTIVE_COMPARATOR

Pharmaceutical care services

Intervention Type 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.

control

physician only team to manage Metabolic syndrome

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

32 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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faculty of pharmacy / University of Jordan

Principal Investigators

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Eman Hammad, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Jordan/ Faculty of Pharmacy

Abla Al bsoul, PhD

Role: STUDY_DIRECTOR

University of Jordan/ Faculty of Pharmacy

Locations

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family medicine clinic JUH

Amman, Amman Governorate, Jordan

Site Status

Countries

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Jordan

Other Identifiers

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JUaym8071383

Identifier Type: -

Identifier Source: org_study_id

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