NCT01298726

Brief Summary

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.

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 Jan 2010

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
Last Updated

February 18, 2011

Status Verified

January 1, 2011

Enrollment Period

8 months

First QC Date

February 17, 2011

Last Update Submit

February 17, 2011

Conditions

DIABETES MELLITUS, TYPE 2

Keywords

PHARMACEUTICAL SERVICESDIABETES MELLITUS

Outcome Measures

Primary Outcomes (1)

  • GLYCATED HEMOGLOBIN (A1C) LEVELS

    glycated hemoglobin levels was determined in the laboratory by high-performance liquid chromatography (HPLC) using venous blood as a sample

    AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)

Secondary Outcomes (7)

  • FASTING GLUCOSE LEVELS

    AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)

  • TOTAL CHOLESTEROL LEVELS

    AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)

  • LDL CHOLESTEROL LEVELS

    AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)

  • HDL CHOLESTEROL LEVELS

    AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)

  • TRIGLYCERIDES LEVELS

    AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)

  • +2 more secondary outcomes

Study Arms (2)

PHARMACEUTICAL CARE

OTHER
Other: PHARMACEUTICAL CARE

HEALTH USUAL CARE

OTHER
Other: HEALTH USUAL CARE

Interventions

PHARMACEUTICAL CAREOTHER

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.

PHARMACEUTICAL CARE
HEALTH USUAL CAREOTHER

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

HEALTH USUAL CARE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • PREGNANT AND NURSING WOMEN
  • PEOPLE UNABLE TO ATTEND THE STUDY SITE
  • PARTICIPANTS OF OTHER PROGRAMS OF PHARMACEUTICAL CARE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Ouro Preto

Ouro Preto, Minas Gerais, 35400-000, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • LISIANE S EV, DR

    Universidade Federal de Ouro Preto

    STUDY CHAIR

  • ANDREA G GRABE, DR

    Universidade Federal de Ouro Preto

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 18, 2011

Study Start

January 1, 2010

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

February 18, 2011

Record last verified: 2011-01

Locations

BR(1)