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Education Interventions Model for Rational Drug Use (RDU)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Education interventional
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Pharmaceutical Education, Rational Drug Use, Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pharmaceutical Education

Control

Arm Description

The patients will receive pharmaceutical education.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Spirometry Exam
To compare the patient´s pulmonary function before and after the education interventions with spirometry exam.
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.
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.
Treatment compliance evaluation
To evaluate the treatment compliance with Morisky&Green test and pharmacy database query before and after educations interventions.
Economic analysis
Economic analysis after the model implementation.
Quality of Life Evaluation
To compare the Quality of Life before and after the education interventions

Full Information

First Posted
January 19, 2011
Last Updated
October 11, 2018
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01281215
Brief Title
Education Interventions Model for Rational Drug Use (RDU)
Official Title
Education Interventions Model for Rational Drug Use
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Pharmaceutical Education, Rational Drug Use, Asthma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmaceutical Education
Arm Type
Experimental
Arm Description
The patients will receive pharmaceutical education.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Education interventional
Other Intervention Name(s)
Pharmaceutical Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knowledge of Asthma
Description
To compare the patient´s knowledge of asthma before and after the education interventions with asthma knowledge questionnaire.
Time Frame
6 months after the first evaluation
Secondary Outcome Measure Information:
Title
Spirometry Exam
Description
To compare the patient´s pulmonary function before and after the education interventions with spirometry exam.
Time Frame
6 months after the first evaluation
Title
Sociodemographic data, clinical and lifestyle evaluation
Description
To evaluate the sociodemographic data, clinical and lifestyle before and after the education interventions and its impact on the quality of life.
Time Frame
6 months after the first evaluation
Title
Management of inhalers
Description
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.
Time Frame
6 months after the first evaluation
Title
Treatment compliance evaluation
Description
To evaluate the treatment compliance with Morisky&Green test and pharmacy database query before and after educations interventions.
Time Frame
6 months after the first evaluation
Title
Economic analysis
Description
Economic analysis after the model implementation.
Time Frame
6 months after the first evaluation
Title
Quality of Life Evaluation
Description
To compare the Quality of Life before and after the education interventions
Time Frame
6 months after the first evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osvaldo de Freitas, habilitation
Organizational Affiliation
Pharmaceutical Sciences Faculty of Ribeirão Preto, University of São Paolo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elcio Vianna, habilitation
Organizational Affiliation
Clinical Hospital of Medicine Faculty of Ribeirão Preto, University of São Paolo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carolina Olivera, Masters
Organizational Affiliation
Pharmaceutical Sciences Faculty of Ribeirão Preto, University of São Paolo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Hospital of Medicine Faculty of Ribeirão Preto, University of São Paolo
City
Ribeirão Preto
State/Province
Sao Paolo
ZIP/Postal Code
14048-800
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27473571
Citation
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.
Results Reference
derived

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Education Interventions Model for Rational Drug Use (RDU)

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