Pharmaceutical Care Service in Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— IMPACT4-DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955875
• Other study ID #: PNU-2014-001
• Status: Completed
• Phase: N/A
• First received: October 26, 2016
• Last updated: November 2, 2016
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: Pusan National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and WelfareKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pusan National University	Pusan National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	HbA1c level at 9 months		9 months	No
Secondary	Random blood glucose level at 9 months		9 months	No
Secondary	Blood pressure at 9 months		9 months	No
Secondary	Cholesterol level at 9 months		9 months	No
Secondary	Proportion of participants taking statins 9 months		9 months	No
Secondary	Proportion of participants managing diabetes complications at 9 months		9 months	No
Secondary	Morisky Medication Adherence Scale at 9 months		9 months	No
Secondary	5-level version of the EQ-5D at 9 months		9 months	No
Secondary	EQ Visual Analogue Scale at 9 months		9 months	No
Secondary	Problem Areas In Diabetes-Korean questionnaire at 9 months		9 months	No
Secondary	Patient Satisfaction Questionnaire-Korean at 9 months		9 months	No
Secondary	Cost-effectiveness of pharmaceutical care at 9 months		9 months	No