Asthma
Conditions
Interventions
This is an open-label, parallel, two-arm (1:1 allocation), cluster- randomized, superiority trial. It consists of the implementation and analysis of the effectiveness and cost-effectiveness of an educ
2) Treatment
and 3) Pulmonary function tests.
Sponsors
Associação Hospitalar Moinhos de Vento
Associação Hospitalar Moinhos de Vento
AstraZeneca Brasil
Eligibility
Age
6 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes, aged between =6 and =65 years at the time of study entry; Medical diagnosis of asthma; Asthma Control Test or Childhood Asthma Control Test with a score < 20; Previous history of two or more episodes of exacerbation; use of bronchodilators and systemic corticosteroids in the last 12 months; Possibility of access by the study team through the patient's personal phone and/or guardians; Patient followed up for at least 3 months in the basic health unit.
Exclusion criteria
Exclusion criteria: Absence of consent to participate in the study by the guardian and/or participant; Patients diagnosed with chronic obstructive pulmonary disease, defined as dyspnea accompanied by chronic cough with or without sputum, recurrent respiratory infections and spirometry with an forced expiratory volume in one second/forced vital capacity index 20 years of smoking or > 10 packs/year); Pregnant women, breastfeeding and/or planned pregnancy during the study period; Hospitalization for asthma in the last 30 days; Cognitive impairment and other conditions that may affect asthma treatment or study adherence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a 50% reduction in the hospitalization rate in the intervention group, evaluated through the number of hospital admissions reported/proved by the research participants. Data will be collected from the 12 months before inclusion in the study and six months after inclusion of the participant in the research | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find a 50% reduction in the number of unscheduled visits to the basic health unit in the intervention group, evaluated through the number of visits to the basic health unit without official pre-scheduling reported/proven by the research participants. Data will be collected 12 months before the intervention and 6 months after the participant's inclusion in the research;A higher percentage of disease control is expected to be observed in the intervention group (score > 20), as measured by the asthma control test applied at inclusion visits and at follow-up visits;It is expected to observe a percentage of at least 10% better quality of life in the intervention group, measured using the asthma quality of life questionnaire applied at inclusion and follow-up visits ;It is expected to find an improvement in lung function, as assessed by spirometry examination with an increase of at least 5% in respiratory amplitude measured at inclusion visits and at follow-up visits;It is expected to find a 50% reduction in the number of emergency admissions in the intervention group, as measured by the number of admissions reported/proven by the research participants. Data will be collected 12 months before the intervention and 6 months after the participant's inclusion in the research | — |
Countries
Brazil
Contacts
Public ContactPaulo Pitrez
Associação Hospitalar Moinhos de Vento
Outcome results
None listed