Pharmaceutical Care Service in Diabetes

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

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Pharmaceutical care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmaceutical care<br>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<br>* Outpatient drug history management, drug regimen review, patient counseling and education before and/or after physician evaluation on the day of facility visit<br>* Other names: Pharmaceutical service;|
| No Intervention: Usual care<br>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?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Pharmaceutical Services