Impact of Pharmaceutical Care in Diabetics Patients

Diabetes Mellitus Type 2 Clinical Trial

— IPCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580904
• Other study ID #: UEParaiba
• Status: Completed
• Phase: N/A
• First received: April 11, 2012
• Last updated: April 17, 2012
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Universidade Estadual da Paraiba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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 LDL, HDL and VLDL, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Intervention: Pharmaceutical Care
Patients will be followed by the pharmacist by the Pharmaceutical Care Practice

Locations

Country	Name	City	State
Brazil	Universidade Estadual da Paraíba	João Pessoa	Paraíba

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual da Paraiba	Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Mitchell B, Armour C, Lee M, Song YJ, Stewart K, Peterson G, Hughes J, Smith L, Krass I. Diabetes Medication Assistance Service: the pharmacist's role in supporting patient self-management of type 2 diabetes (T2DM) in Australia. Patient Educ Couns. 2011 Jun;83(3):288-94. doi: 10.1016/j.pec.2011.04.027. Epub 2011 May 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycated hemoglobin		Up to 24 weeks	No
Secondary	blood glucose		Up to 24 weeks	No
Secondary	total cholesterol		Up to 24 weeks	No
Secondary	fractions of HDL, LDL and VLDL cholesterol		Up to 24 weeks	No

External Links

•   A journal that has a lot of research on this topic
•   An interesting article on this topic
•   An interesting article on this topic