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临床试验/NCT01099306
NCT01099306已完成不适用

Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

University of Jordan2 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
199
试验地点
2
主要终点
Improvements in metabolic syndrome status over the course of this study and absolute mean improvements in individual MS components.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Care Provider)

入排标准

年龄范围
32 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Improvements in metabolic syndrome status over the course of this study and absolute mean improvements in individual MS components.

时间窗: 6 monthS

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.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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