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

April 11, 2012
April 17, 2012
September 2009
December 2011   (final data collection date for primary outcome measure)
glycated hemoglobin [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01580904 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Impact of Pharmaceutical Care in Diabetics Patients
Popular Pharmacy of Brazil: Impact of Pharmaceutical Care in Diabetics Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
Behavioral: Intervention: Pharmaceutical Care
Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
  • No Intervention: control group
    Patients will not be followed by the pharmacist.
  • Experimental: Intervention group
    Patients will be followed by the pharmacist.
    Intervention: Behavioral: Intervention: Pharmaceutical Care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01580904
UEParaiba
Yes
Patrícia Trindade Costa Paulo, Universidade Estadual da Paraiba
Universidade Estadual da Paraiba
Universidade Federal do Rio Grande do Norte
Study Director: Ivonete Araújo Doutorado Universidade Federal do Rio Grande do Norte
Universidade Estadual da Paraiba
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP