Pharmaceutical Care Service in Diabetes (IMPACT4-DM)

November 2, 2016 updated by: Jeong-Hyun Yoon, Pusan National University

Impact of Pharmaceutical Care Service for Type 2 Diabetes Mellitus Patients in Korea

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

257

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
Other Names:
  • Pharmaceutical service
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University

Collaborators

Pusan National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 4, 2016

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNU-2014-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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