Severe asthma
Conditions
Interventions
A randomized controlled trial with a duration of 12 months, in which 29 children and adolescents, aged between three and 17 years, were referred to the Multidisciplinary Center for Patients with Diffi
Behavioural
Sponsors
Universidade Federal de Minas Gerais
Universidade Federal de Minas Gerais
Eligibility
Age
3 Years to 17 Years
Inclusion criteria
Inclusion criteria: To be patients of the Multidisciplinary Center for Patients with Asthma of Difficult Control; be between 3 and 18 years of age; be residents of Belo Horizonte or metropolitan region.
Exclusion criteria
Exclusion criteria: Residing outside Belo Horizonte and metropolitan áreas; having other pathologies such as cystic fibrosis; ciliary dyskinesia; tuberculosis; bronchiolitis obliterans post infectious; interstitial pneumopathies, congenital pulmonary and bronchial tree malformations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was the inhalation technique score. To evaluate the score, a validated instrument containing 8 items of inhalation technique was used. Baseline evaluation (pre-intervention) was performed, where the inhalation technique was reviewed, and two evaluations (post-intervention), with a median time interval of 35 days. A score was scored for each score (generating a score from zero to 8) to allow the detection of the mean difference of one unit between the pre and post intervention evaluations with deviation of 0.9. The higher the score the better the inhalation technique. To detect this difference between the two evaluations, with statistical power of 80% and confidence level of 95%, the sample size needed to detect difference between two evaluations would be 26 patients, being 13 cases and 13 controls. According to the distribution of the frequencies, we used averages and / or medians. Student's t-tests, Fisher exact, chi-square with Yates correction, Mc Nemar chi-square, paired Student t and Mann-Whitney were used for evaluation of primary outcomes, when indicated. The final significance level was p <0.05.;Elevation of the inhalation technique scores and the detection of the mean difference of one unit of the inhalation technique score between the pre- and post-intervention evaluations. At baseline (pre-intervention) the inhalation technique score of the intervention and control groups was 5.92 and 6.69, respectively. In the post-intervention evaluations, a score of 7.61 (p = 0.007) was obtained for the intervention group, and for the control group the score obtained was 7.0 (p = 0.3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of clinical control at one point, directly related to primary outcome (increase in inhalation technique scores). Clinical control was assessed using the Asthma Control Test (ACT), which is a validated instrument whose maximum score is 25, and the cutoff point of 20 determines that the patient is controlled.;The rate of adherence to inhaled corticosteroids was another secondary outcome, with a final post-intervention rate of greater than or equal to 80% expected. To measure the adhesion rate, we used the measurement of the beginning and end dates of inhaled corticosteroids, according to the description of this already standardized method. The patient or caretaker was instructed to note in the vial the start date of the inhaled corticosteroid and, by means of the medication dose counter, a calculation was performed subtracting the amount of doses used from the amount of doses prescribed for the period. It was evaluated, according to the distribution of the data, by means of a mean or median comparison.; A mean of 52.1 (median of 64.5) and 58.4 (median of 85.0) respectively, p = 0.8, were found in the baseline assessment of adherence rates measured for intervention and control groups. For the intervention group in evaluations 2 and 3, adherence rates were found with a median of 94.0 and 96.5, p = 0.79. For the control group at assessments 2 and 3, adherence rates were found with median of 92.5 and 98.0 respectively, p = 0.35. There were no statistically significant changes in the rates of inhaled corticosteroid adherence for any of the groups, however, it was observed that in both groups we found high adhesion rates greater than 80%. ;The baseline assessment of the intervention group showed a mean ACT of 23.08 and a median of 24, and in the control group, an average of 18.47 and a median of 18, p = 0.005. Despite the randomization, there was a significant difference between groups regarding the control of asthma symptoms. For the intervention group, in eva | — |
Countries
Brazil
Contacts
Public ContactDaniela Bresolini
Universidade Federal de Minas Gerais
Outcome results
None listed