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Impact of Pharmaceutical Care in Diabetics Patients (IPCD)

Primary Purpose

Diabetes Mellitus Type 2

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intervention: Pharmaceutical Care
Sponsored by
Universidade Estadual da Paraiba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring Pharmaceutical Care, Diabetics patients, Clinical trial

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidade Estadual da Paraíba

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

Intervention group

Arm Description

Patients will not be followed by the pharmacist.

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

Outcomes

Primary Outcome Measures

Glycated Hemoglobin
average glycated hemoglobin over 24 weeks
Fasting Glycemia
average fasting glycemia over 24 weeks

Secondary Outcome Measures

Total Cholesterol
average total cholesterol over 24 weeks
LDL Cholesterol
average LDL cholesterol over 24 weeks

Full Information

First Posted
April 11, 2012
Last Updated
December 19, 2016
Sponsor
Universidade Estadual da Paraiba
Collaborators
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT01580904
Brief Title
Impact of Pharmaceutical Care in Diabetics Patients
Acronym
IPCD
Official Title
Popular Pharmacy of Brazil: Impact of Pharmaceutical Care in Diabetics Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual da Paraiba
Collaborators
Universidade Federal do Rio Grande do Norte

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
Pharmaceutical Care, Diabetics patients, Clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients will not be followed by the pharmacist.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin. Intervention: Pharmaceutical Care
Intervention Type
Behavioral
Intervention Name(s)
Intervention: Pharmaceutical Care
Intervention Description
Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
Primary Outcome Measure Information:
Title
Glycated Hemoglobin
Description
average glycated hemoglobin over 24 weeks
Time Frame
Up to 24 weeks
Title
Fasting Glycemia
Description
average fasting glycemia over 24 weeks
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Total Cholesterol
Description
average total cholesterol over 24 weeks
Time Frame
Up to 24 weeks
Title
LDL Cholesterol
Description
average LDL cholesterol over 24 weeks
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivonete A. Doutorado
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Estadual da Paraíba
City
João Pessoa
State/Province
Paraíba
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21616627
Citation
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.
Results Reference
background
Links:
URL
http://www.pharmacypractice.org/
Description
A journal that has a lot of research on this topic
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2387287/
Description
An interesting article on this topic

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Impact of Pharmaceutical Care in Diabetics Patients

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