NCT01580904

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

February 10, 2017

Completed
Last Updated

February 10, 2017

Status Verified

December 1, 2016

Enrollment Period

2.2 years

First QC Date

April 11, 2012

Results QC Date

March 11, 2016

Last Update Submit

December 19, 2016

Conditions

Diabetes Mellitus Type 2

Keywords

Pharmaceutical CareDiabetics patientsClinical trial

Outcome Measures

Primary Outcomes (2)

  • Glycated Hemoglobin

    average glycated hemoglobin over 24 weeks

    Up to 24 weeks

  • Fasting Glycemia

    average fasting glycemia over 24 weeks

    Up to 24 weeks

Secondary Outcomes (2)

  • Total Cholesterol

    Up to 24 weeks

  • LDL Cholesterol

    Up to 24 weeks

Study Arms (2)

control group

NO INTERVENTION

Patients will not be followed by the pharmacist.

Intervention group

EXPERIMENTAL

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

Behavioral: Intervention: Pharmaceutical Care

Interventions

Intervention: Pharmaceutical CareBEHAVIORAL

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

Intervention group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged 30 years,
  • diagnosed with type 2 diabetes,
  • to make use of oral antidiabetic agents with or without insulin

You may not qualify if:

  • those who had infectious diseases during the research
  • missed three consecutive interviews,
  • suspended the hypoglycemic drug and medical order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Estadual da Paraíba

João Pessoa, Paraíba, Brazil

Location

Related 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.

    PMID: 21616627BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Impacto da Atenção Farmacêutica em pacientes diabéticos (IPCD)
Organization
Universidade Estadual da Paraíba
patriciatrindad@yahoo.com.br
558387010977

Study Officials

  • Ivonete A. Doutorado

    Universidade Federal do Rio Grande do Norte

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Impact of Pharmaceutical Care in Diabetics Patients: Clinical Trial Randomized

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 19, 2012

Study Start

September 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 10, 2017

Results First Posted

February 10, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)