NCT01281215

Brief Summary

The purpose of this study is to develop, implement and evaluate an economically viable and efficient interventions education model for rational drug use, adaptable to different pathological situations and should be implemented into Brazil Heath Care System.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Mar 2011

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

First Submitted

Initial submission to the registry

January 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

January 19, 2011

Last Update Submit

October 11, 2018

Conditions

Asthma

Keywords

Pharmaceutical EducationRational Drug UseAsthma

Outcome Measures

Primary Outcomes (1)

  • Knowledge of Asthma

    To compare the patient´s knowledge of asthma before and after the education interventions with asthma knowledge questionnaire.

    6 months after the first evaluation

Secondary Outcomes (6)

  • Spirometry Exam

    6 months after the first evaluation

  • Sociodemographic data, clinical and lifestyle evaluation

    6 months after the first evaluation

  • Management of inhalers

    6 months after the first evaluation

  • Treatment compliance evaluation

    6 months after the first evaluation

  • Economic analysis

    6 months after the first evaluation

  • +1 more secondary outcomes

Study Arms (2)

Pharmaceutical Education

EXPERIMENTAL

The patients will receive pharmaceutical education.

Behavioral: Education interventional

Control

NO INTERVENTION

Interventions

Education interventionalBEHAVIORAL

The patients will receive pharmaceutical education to know more about asthma, the importance of treatment compliance, the medications used to control the pathology, corrected patients' inhalation techniques and the medication care.

Also known as: Pharmaceutical Care
Pharmaceutical Education

Eligibility Criteria

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

You may qualify if:

  • Subject with asthma diagnosed according to criteria of the Global Strategy for Asthma Management and Prevention;
  • Subject is a male or female with 18 to 73 years-old;
  • Subject who has access to medications supplied by the the Brazil Heath Care System;
  • Subject unable to perform the procedures or conditions such as pregnancy that may affect the results of the study;
  • Literate subject without Cognitive Disorders, Alzheimer's, Dementia, that can limit the ability to participate in this study;
  • Subject who have availability to attend the monthly meetings;
  • Subject provides written informed consent and attend the first evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital of Medicine Faculty of Ribeirão Preto, University of São Paolo

Ribeirão Preto, São Paulo, 14048-800, Brazil

Location

Related Publications (1)

  • Olivera CM, Vianna EO, Bonizio RC, de Menezes MB, Ferraz E, Cetlin AA, Valdevite LM, Almeida GA, Araujo AS, Simoneti CS, de Freitas A, Lizzi EA, Borges MC, de Freitas O. Asthma self-management model: randomized controlled trial. Health Educ Res. 2016 Oct;31(5):639-52. doi: 10.1093/her/cyw035. Epub 2016 Jul 29.

    PMID: 27473571DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Osvaldo de Freitas, habilitation

    Pharmaceutical Sciences Faculty of Ribeirão Preto, University of São Paolo

    STUDY DIRECTOR

  • Elcio Vianna, habilitation

    Clinical Hospital of Medicine Faculty of Ribeirão Preto, University of São Paolo

    STUDY DIRECTOR

  • Carolina Olivera, Masters

    Pharmaceutical Sciences Faculty of Ribeirão Preto, University of São Paolo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Masters

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 21, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations

BR(1)