Asthma Clinical Trial
Official title:
Education Interventions Model for Rational Drug Use
| NCT number | NCT01281215 |
| Other study ID # | FR - 381298 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2011 |
| Est. completion date | October 2012 |
| Verified date | October 2018 |
| Source | University of Sao Paulo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | October 2012 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Clinical Hospital of Medicine Faculty of Ribeirão Preto, University of São Paolo | Ribeirão Preto | Sao Paolo |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sao Paulo |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Spirometry Exam | To compare the patient´s pulmonary function before and after the education interventions with spirometry exam. | 6 months after the first evaluation | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Economic analysis | Economic analysis after the model implementation. | 6 months after the first evaluation | |
| Secondary | Quality of Life Evaluation | To compare the Quality of Life before and after the education interventions | 6 months after the first evaluation |
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