Education Interventions Model for Rational Drug Use (RDU)

Education Interventions Model for Rational Drug Use

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Education interventional

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paolo
    • Ribeirão Preto, Sao Paolo, Brazil, 14048-800
      • Clinical Hospital of Medicine Faculty of Ribeirão Preto, University of São Paolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
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 Names: Pharmaceutical Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spirometry Exam	To compare the patient´s pulmonary function before and after the education interventions with spirometry exam.	6 months after the first evaluation
Sociodemographic data, clinical and lifestyle evaluation	To evaluate the sociodemographic data, clinical and lifestyle before and after the education interventions and its impact on the quality of life.	6 months after the first evaluation
Management of inhalers	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.	6 months after the first evaluation
Treatment compliance evaluation	To evaluate the treatment compliance with Morisky&Green test and pharmacy database query before and after educations interventions.	6 months after the first evaluation
Economic analysis	Economic analysis after the model implementation.	6 months after the first evaluation
Quality of Life Evaluation	To compare the Quality of Life before and after the education interventions	6 months after the first evaluation

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: January 19, 2011
• First Submitted That Met QC Criteria: January 20, 2011
• First Posted (Estimate): January 21, 2011

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Asthma; Rational Drug Use; Pharmaceutical Education
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: FR - 381298