Pharmaceutical Care Service in Diabetes

Overview

The purpose of this study is to examine the effectiveness of pharmaceutical care service in the management of poorly controlled type 2 diabetes mellitus.

Full Title of Study: “Impact of Pharmaceutical Care Service for Type 2 Diabetes Mellitus Patients in Korea”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 2016

Interventions

  • Behavioral: Pharmaceutical care
    • Outpatient drug history management, drug regimen review, patient counseling and education before and/or after physician evaluation on the day of facility visit

Arms, Groups and Cohorts

  • Experimental: Pharmaceutical care
    • Participants received systematically organized pharmaceutical care services, which were provided by pharmacists, in addition to the usual care. The usual care includes traditional consultation with pharmacists as well as traditional medical services provided by physicians, nurses, and dietitian.
  • No Intervention: Usual care
    • Participants received the usual care, which includes traditional consultation with pharmacists as well as traditional medical services provided by physicians, nurses, and dietitian.

Clinical Trial Outcome Measures

Primary Measures

  • Medications knowledge at 9 months
    • Time Frame: 9 months
    • Patients’ knowledge about diabetes medications was measured by an instrument. The instrument includes items such as the name of medication, mechanism of action, dosage, and side effects.

Secondary Measures

  • HbA1c level at 9 months
    • Time Frame: 9 months
  • Random blood glucose level at 9 months
    • Time Frame: 9 months
  • Blood pressure at 9 months
    • Time Frame: 9 months
  • Cholesterol level at 9 months
    • Time Frame: 9 months
  • Proportion of participants taking statins 9 months
    • Time Frame: 9 months
  • Proportion of participants managing diabetes complications at 9 months
    • Time Frame: 9 months
  • Morisky Medication Adherence Scale at 9 months
    • Time Frame: 9 months
  • 5-level version of the EQ-5D at 9 months
    • Time Frame: 9 months
  • EQ Visual Analogue Scale at 9 months
    • Time Frame: 9 months
  • Problem Areas In Diabetes-Korean questionnaire at 9 months
    • Time Frame: 9 months
  • Patient Satisfaction Questionnaire-Korean at 9 months
    • Time Frame: 9 months
  • Cost-effectiveness of pharmaceutical care at 9 months
    • Time Frame: 9 months

Participating in This Clinical Trial

Inclusion Criteria

Patients who visit Endocrinology and Metabolism department of Pusan National University Hospital, are with type 2 diabetes mellitus, and meet one of the following criteria

  • Who are diagnosed with type 2 diabetes mellitus for the first time – Who need the education for medication or disease – Who are with poorly controlled blood glucose – Who have poor medication adherence – Who have been hospitalized with diabetes complication or poorly controlled blood glucose – Whose physician recommend the pharmaceutical care to them Exclusion Criteria:

Patients who meet one of the following criteria

  • Who are with gestational diabetes – Who are not able to respond to questionnaires – Who are with severe condition such as cerebrovascular disease, mental disorder, and acquired immune deficiency syndrome – Who are not able to be followed-up during 9 months in Pusan National University Hospital

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pusan National University
  • Collaborator
    • Pusan National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jeong-Hyun Yoon, Associate professor – Pusan National University

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