Pharmaceutical Care Service in Diabetes (IMPACT4-DM)

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: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Pharmaceutical care

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Not Applicable

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• Sponsor: Pusan National University
• Collaborators: Pusan National University Hospital

Study record dates

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: Diabetes Mellitus, Type 2; Pharmaceutical Services
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PNU-2014-001