Impact of Pharmaceutical Care in Diabetics Patients

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 2

• Registration Number: NCT01580904
• Lead Sponsor: Universidade Estadual da Paraiba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-17
• Study First Posted: 2012-04-19
• Results First Submitted: 2016-03-11
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-19
• Last Update Submitted: 2016-12-19
• Results First Posted: 2017-02-10
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Glycated Hemoglobin	Up to 24 weeks	average glycated hemoglobin over 24 weeks
Fasting Glycemia	Up to 24 weeks	average fasting glycemia over 24 weeks

Secondary Outcome Measures

Name	Time	Method
Total Cholesterol	Up to 24 weeks	average total cholesterol over 24 weeks
LDL Cholesterol	Up to 24 weeks	average LDL cholesterol over 24 weeks

Trial Locations

Locations (1)

Universidade Estadual da Paraíba; 🇧🇷 João Pessoa, Paraíba, Brazil