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Impact of Pharmaceutical Care in Diabetics Patients (IPCD)

This study has been completed.
Sponsor:
Collaborator:
Universidade Federal do Rio Grande do Norte
Information provided by (Responsible Party):
Patrícia Trindade Costa Paulo, Universidade Estadual da Paraiba
ClinicalTrials.gov Identifier:
NCT01580904
First received: April 11, 2012
Last updated: April 17, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus Type 2
 Behavioral: Intervention: Pharmaceutical Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Popular Pharmacy of Brazil: Impact of Pharmaceutical Care in Diabetics Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade Estadual da Paraiba:

Primary Outcome Measures:
  • glycated hemoglobin [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood glucose [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • total cholesterol [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • fractions of HDL, LDL and VLDL cholesterol [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
Patients will not be followed by the pharmacist.
Experimental: Intervention group
Patients will be followed by the pharmacist.
 Behavioral: Intervention: Pharmaceutical Care
Patients will be followed by the pharmacist by the Pharmaceutical Care Practice

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580904

Locations
Brazil
Universidade Estadual da Paraíba
João Pessoa, Paraíba, Brazil
Sponsors and Collaborators
Universidade Estadual da Paraiba
Universidade Federal do Rio Grande do Norte
Investigators
Study Director: Ivonete Araújo Doutorado Universidade Federal do Rio Grande do Norte
  More Information

Additional Information:
A journal that has a lot of research on this topic  This link exits the ClinicalTrials.gov site
An interesting article on this topic  This link exits the ClinicalTrials.gov site
An interesting article on this topic  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Patrícia Trindade Costa Paulo, Impact of Pharmaceutical Care in Diabetics Patients: Clinical Trial Randomized, Universidade Estadual da Paraiba
ClinicalTrials.gov Identifier: NCT01580904     History of Changes
Other Study ID Numbers: UEParaiba
Study First Received: April 11, 2012
Last Updated: April 17, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Estadual da Paraiba:
Pharmaceutical Care
Diabetics patients
Clinical trial

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013