Impact of Pharmaceutical Care Service for Type 2 Diabetes Mellitus Patients in Korea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pusan National University
- Enrollment
- 257
- Primary Endpoint
- Medications knowledge at 9 months
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Pharmaceutical care (Behavioral)
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.
Outcomes
Primary Outcomes
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 Outcomes
- EQ Visual Analogue Scale at 9 months(9 months)
- 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)
- 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)
Investigators
Jeong-Hyun Yoon
Associate professor
Pusan National University