Impact of Pharmaceutical Care in Diabetics Patients

NCT ID: NCT01580904

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-12-31

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.

Conditions

Diabetes Mellitus Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

Patients will not be followed by the pharmacist.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.

Intervention: Pharmaceutical Care

Group Type: EXPERIMENTAL

Intervention: Pharmaceutical Care

Intervention Type: BEHAVIORAL

Patients will be followed by the pharmacist by the Pharmaceutical Care Practice

Interventions

Intervention: Pharmaceutical Care

Patients will be followed by the pharmacist by the Pharmaceutical Care Practice

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: collaborator

Universidade Estadual da Paraiba

OTHER

Sponsor Role: lead

Responsible Party

Patrícia Trindade Costa Paulo

Impact of Pharmaceutical Care in Diabetics Patients: Clinical Trial Randomized

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivonete A. Doutorado

Role: STUDY_DIRECTOR

Universidade Federal do Rio Grande do Norte

Locations

Universidade Estadual da Paraíba

João Pessoa, Paraíba, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 21616627 (View on PubMed)

Related Links

http://www.pharmacypractice.org/

A journal that has a lot of research on this topic

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2387287/

An interesting article on this topic

Other Identifiers

UEParaiba

Identifier Type: -

Identifier Source: org_study_id