Pharmaceutical Care in Type 2 Diabetes

NCT ID: NCT01298726

Last Updated: 2011-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-10-31

Brief Summary

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The purpose of this study is to examine the effect of a pharmaceutical care program on the level of glycated hemoglobin for hyperglycemic users of brazilian public health care system in drug treatment for type 2 diabetes.

Detailed Description

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The chronic diseases, including diabetes mellitus (DM) are a major public health problems of today. There is evidence that glycated hemoglobin (A1C) levels above 7% are associated with a progressively greater risk of chronic complications related to DM. However, approximately 60% of diabetics do not achieve glycemic control. In Brazil, pharmacists are not involved in direct care of patients with DM. The investigators conducted a randomized controlled trial, for six months, in Ouro Preto, Minas terais to determine the effect of pharmaceutical intervention on glycemic control in patients with diabetes and hyperglycemic (A1C \> 7%). One hundred and twenty-nine subjects were randomized to receive usual care only or usual care and pharmaceutical intervention. The population of those who had access in the brazilian public health care system, as consultations with doctors, nurses and nutritionists, laboratory tests and access to essential medicines were considered as conventional health care.

Conditions

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DIABETES MELLITUS, TYPE 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PHARMACEUTICAL CARE

Group Type OTHER

PHARMACEUTICAL CARE

Intervention Type OTHER

The pharmaceutical care program was characterized by face to face monthly visits to collect information, register information, prepare plan of care for every health problem; identification of drug therapy problems, communication to prescribers the drug therapy problems identified and education of participants to resolve the drug therapy problems.

HEALTH USUAL CARE

Group Type OTHER

HEALTH USUAL CARE

Intervention Type OTHER

Usual care as defined in health consultations with doctors, nutritionists and nurses, access to laboratory tests and essential medicines

Interventions

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PHARMACEUTICAL CARE

The pharmaceutical care program was characterized by face to face monthly visits to collect information, register information, prepare plan of care for every health problem; identification of drug therapy problems, communication to prescribers the drug therapy problems identified and education of participants to resolve the drug therapy problems.

Intervention Type OTHER

HEALTH USUAL CARE

Usual care as defined in health consultations with doctors, nutritionists and nurses, access to laboratory tests and essential medicines

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* MINIMAL AGE 18 YEARS OLD
* USE OF DIABETES ORAL MEDICATION
* MINIMAL GLYCOHEMOGLOBIN 7%

Exclusion Criteria

* PREGNANT AND NURSING WOMEN
* PEOPLE UNABLE TO ATTEND THE STUDY SITE
* PARTICIPANTS OF OTHER PROGRAMS OF PHARMACEUTICAL CARE
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Ouro Preto

OTHER

Sponsor Role lead

Responsible Party

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UNIVERSIDADE FEDERAL DE OURO PRETO

Principal Investigators

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LISIANE S EV, DR

Role: STUDY_CHAIR

Universidade Federal de Ouro Preto

ANDREA G GRABE, DR

Role: STUDY_DIRECTOR

Universidade Federal de Ouro Preto

Locations

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Universidade Federal de Ouro Preto

Ouro Preto, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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0040.0.238.000-09

Identifier Type: -

Identifier Source: org_study_id

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