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Education Interventions Model for Rational Drug Use (RDU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carolina Maria Xaubet Olivera, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01281215
First received: January 19, 2011
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Asthma
 Behavioral: Education interventional

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Education Interventions Model for Rational Drug Use

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Knowledge of Asthma [ Time Frame: 6 months after the first evaluation ] [ Designated as safety issue: No ]
    To compare the patient´s knowledge of asthma before and after the education interventions with asthma knowledge questionnaire.


Secondary Outcome Measures:
  • Spirometry Exam [ Time Frame: 6 months after the first evaluation ] [ Designated as safety issue: No ]
    To compare the patient´s pulmonary function before and after the education interventions with spirometry exam.

  • Sociodemographic data, clinical and lifestyle evaluation [ Time Frame: 6 months after the first evaluation ] [ Designated as safety issue: No ]
    To evaluate the sociodemographic data, clinical and lifestyle before and after the education interventions and its impact on the quality of life.

  • Management of inhalers [ Time Frame: 6 months after the first evaluation ] [ Designated as safety issue: No ]
    To evaluate the technique for using inhalation devices among asthma patients before and after education interventions. Patients will be asked to demonstrate their inhaler technique.

  • Treatment compliance evaluation [ Time Frame: 6 months after the first evaluation ] [ Designated as safety issue: No ]
    To evaluate the treatment compliance with Morisky&Green test and pharmacy database query before and after educations interventions.

  • Economic analysis [ Time Frame: 6 months after the first evaluation ] [ Designated as safety issue: No ]
    Economic analysis after the model implementation.

  • Quality of Life Evaluation [ Time Frame: 6 months after the first evaluation ] [ Designated as safety issue: No ]
    To compare the Quality of Life before and after the education interventions


Enrollment: 120
Study Start Date: March 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pharmaceutical Education
The patients will receive pharmaceutical education.
 Behavioral: Education interventional
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.
Other Name: Pharmaceutical Care
No Intervention: Control

Detailed Description:

Currently, the educational interventions regarding the use of medicines need to be expanded and more effective, and thus set themselves up in strategies for reorganization of dispensing drugs in health services and provide support to the population to obtain greater control over their health. The pharmacist, in turn, inserted in the multidisciplinary team has an important role in health education with the aim of improving knowledge about the disease and the various treatment options, reflecting positively on treatment adherence and clinical outcomes as a result and quality of life related to patient health. Thus, health education, to share knowledge, represents an important task and involves attentive listening to the community to identify their needs and then solve them. From this perspective, therefore, the educational means to educate health and an integral formation of individuals as social actors critics who understand and question the social relations, transforming subjects into citizens participating in the process of health education, helping to raise awareness , knowledge and understanding of living conditions and relationships with health, promoting quality of life.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subject who cannot be classified in the inclusion criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281215

Locations
Brazil
Clinical Hospital of Medicine Faculty of Ribeirão Preto, University of São Paolo
Ribeirão Preto, Sao Paolo, Brazil, 14048-800
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: 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
Principal Investigator: Carolina Olivera, Masters Pharmaceutical Sciences Faculty of Ribeirão Preto, University of São Paolo
  More Information

No publications provided

Responsible Party: Carolina Maria Xaubet Olivera, Masters, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01281215     History of Changes
Other Study ID Numbers: FR - 381298
Study First Received: January 19, 2011
Last Updated: October 31, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Pharmaceutical Education
Rational Drug Use
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013