Impact of Pharmaceutical Care in Diabetics Patients

Study Overview
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Brief Summary
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The monitoring of diabetics by the pharmacist may contribute to the effectiveness of drug treatment and to improve their quality of life. This study will measure the impact of pharmacotherapeutic follow-up in diabetic patients. This will be a clinical trial, single blind, controlled, randomized, conducted in two units of pharmacies in Brazil. Only in the intervention group will be held the pharmacotherapeutic follow using a methodology called the practice of pharmaceutical care, which identifies and resolves problems related to drugs. The primary outcome is glycated hemoglobin, and secondary outcomes are baseline glucose, total cholesterol and its fractions (for example LDL), all these measures will be made in the intervention group and control group. Patients will be followed for 24 weeks, and the outcomes will be assessed up to 24 weeks. There will be a confidence interval of 95% and a significance of p <0.05, and will use the Student t test, chi-square analysis of variance (ANOVA) and others if necessary. Expects good results and serve as a model for other researchers.

Official Title
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Popular Pharmacy of Brazil: Impact of Pharmaceutical Care in Diabetics Patients

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Behavioral: Intervention: Pharmaceutical Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Inclusion criteria: patients aged 30 years, diagnosed with type 2 diabetes, to make use of oral antidiabetic agents with or without insulin Exclusion Criteria: those who had infectious diseases during the research missed three consecutive interviews, suspended the hypoglycemic drug and medical order

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Patients will not be followed by the pharmacist. | |
| Experimental: Intervention group<br>Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin. Intervention: Pharmaceutical Care | Behavioral: Intervention: Pharmaceutical Care<br>* Patients will be followed by the pharmacist by the Pharmaceutical Care Practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated Hemoglobin | average glycated hemoglobin over 24 weeks | Up to 24 weeks | 
| Fasting Glycemia | average fasting glycemia over 24 weeks | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol | average total cholesterol over 24 weeks | Up to 24 weeks | 
| LDL Cholesterol | average LDL cholesterol over 24 weeks | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmaceutical Care, Diabetics patients, Clinical trial