Impact of Educational Intervention Protocol on the Level of Knowledge, Clinical Control and Lung Function of People With Asthma: Randomized Controlled Clinical Trial
Phase: NA
Conditions: Asthma
Sponsor: Federal University of Paraíba

 
 
FEDERAL UNIVERSITY OF PARAIBA 
HEALTH SCIENCE CENTER 
PHISIOTERAPY DEPARTMENT 
DEAN OF RESEARCH 
 
 
 
RESEARCH PROJECT 
 
 
IMPACT OF EDUCATIONAL INTERVENTION PROTOCOL ON THE LEVEL 
OF KNOWLEDGE, CLINICAL CONTROL AND LUNG FUNCTION OF 
PEOPLE WITH ASTHMA: RANDOMIZED CONTROLLED CLINICAL 
TRIAL. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
JOÃO PESSOA 
2025 
 
 
 

 
 
FEDERAL UNIVERSITY OF PARAIBA 
HEALTH SCIENCE CENTER 
PHISIOTERAPY DEPARTMENT 
DEAN OF RESEARCH 
 
 
RESEARCH PROJECT 
 
 
IMPACT OF EDUCATIONAL INTERVENTION PROTOCOL ON THE LEVEL 
OF KNOWLEDGE, CLINICAL CONTROL AND LUNG FUNCTION OF 
PEOPLE WITH ASTHMA: RANDOMIZED CONTROLLED CLINICAL 
TRIAL. 
 
Impact of educational intervention protocol on the level of knowledge, clinical control 
and lung function of people with asthma: randomized controlled clinical trial. 
 
 
Research project submitted to the UFPB Pro-
Rectory 
for 
Research, 
Notice 
01/2024- 
Vigência2024/2025- PIBIC, PIBIC-AF, PIBITI, 
PIVIC, PIVITI 
 
 
Proposer: Prof Dra. Renata R. Tomaz Barbosa 
 
 
 
 
JOÃO PESSOA 
2025/03/04 
 
 
 
 
 

Title: Impact of educational intervention protocol on the level of knowledge, clinical 
control and lung function of people with asthma: randomized controlled clinical trial. 
Keywords: Heath Education, Asthma, Spirometry, Respiratory Tract Disease.  
 
Abstract 
 
Objective: To evaluate the effects of a proposed educational intervention on people 
with asthma attending the Pulmonary Function Clinic in the city of João Pessoa -PB. 
Method: randomized controlled clinical trial, conducted in accordance with CONSORT 
recommendations. People with asthma will participate in the study, from the Pulmonary 
Function Clinic of the Department of Physiotherapy at UFPB. Study participants will be 
allocated into two groups (experimental and control). Individuals allocated to the 
control group will receive standard follow-up according to the clinic routine. Patients 
allocated to the experimental group will undergo an educational intervention BUNDLE, 
prepared in accordance with the recommendations of the Global Initiative for Asthma- 
GINA (2024). Spirometry date, knowledge about asthma and correct control over 
inhalation therapy by the Angeline’s questionaire, clinical control of the disease using 
the Asthma Control Test (ACT) and Children Asthma Control Test (C-ACT) 
questionnaire, number of asthma attacks, amount of medication used, hospitalizations 
and visit. to the emergency room in the last 4 weeks will be assessed. Assessments will 
be carried out at the first contact (baseline) and four weeks after the first contact. 
Statistical analysis: Qualitative variables will be described in absolute and relative 
frequencies. For quantitative variables, normality will initially be tested using the 
Kolmogorov-Smirnov test, and the data will be described according to their distribution. 
The paired t test, or non-parametric test, Wilcoxon, will be used to compare the values 
obtained pre and post intervention. The relationship between the number of correct 
answers and the categorical variables will be evaluated using the Student's t test or 
ANOVA, according to the number of variable categories. A multiple linear regression 
analysis (Stepwise method) will be carried out between the independent variables, to 
assess which are capable of determining the variation in the number of correct answers 
(retention and knowledge about asthma and inhalation therapy). For each outcome, the 
covariates that presented p <0.20 in the bivariate analysis will be used in the regression. 
Variables with p <0.05 will be considered and retained in the final model. A 
significance level or p-value <0.05 and 95% confidence intervals will be used for all 

tests. Expected results: This study aims to contribute to a better understanding of the 
effectiveness of educational intervention strategies in people with asthma. From this 
perspective, the results of this research may help in the future to identify barriers and 
facilitators associated with the retention and adherence of users' knowledge about 
asthma, aiming to serve as a precursor in the development of health education strategies 
for other chronic respiratory pathologies. 
 
 
INTRODUCTION 
 
Asthma 
is 
a 
chronic 
inflammatory 
disease 
characterized 
by 
hyperresponsiveness of the lower airways and variable airflow limitation. It is clinically 
manifested by recurrent episodes of wheezing, dyspnea, chest tightness and coughing, 
and results from an interaction between genetics, environmental exposure and other 
specific factors that lead to the development and maintenance of symptoms. [1, 2] 
According to the Global Initiative for Asthma - GINA (2024), asthma 
affects around 300 million people worldwide and, due to its high frequency in children, 
it is suggested that there will be an increase in the overall prevalence of this disease in 
the coming years.[1, 3–5] 
Epidemiological data show that asthma is the fourth leading cause of 
hospitalizations in the Brazilian Unified Health System (SUS) [3, 4] and, due to its high 
prevalence and comorbidity, it should be considered a public health problem, requiring 
the implementation of effective measures to control it [5, 6].   
The Brazilian Ministry of Health highlights the importance of health 
promotion for people with chronic respiratory diseases, including asthma, with 
considerable positive repercussions on the management of the disease.  Among these 
strategies, health education is considered a useful, effective and recommended resource 
for controlling chronic respiratory diseases, with a significant influence on reducing 
morbidity rates and increasing quality of life. [7]   
Health education strategies have been considered essential for asthma 
control, as they promote knowledge, increase the ability to identify aggravating and 
triggering factors, and improve adherence to treatment. [7, 8] 
Brazilian researchers have observed the existence of barriers to the 

participation of users in asthma education programs, with emphasis on the lack of 
infrastructure, especially human resources, and difficulty in maintaining patient follow-
up.[8] It should also be noted that the greater number of structural barriers, such as lack 
of time, financial resources, the fact of living far away and the need for frequent returns 
to the health service reduces the possibility of a patient participating in a health 
education program.[8–10] 
Angelini et al (2009), observed the effectiveness of a health education 
protocol in the knowledge, management and clinical control of asthma in adult 
individuals treated at an outpatient clinic of a reference center for asthma treatment in 
the city of São Paulo. However, out of a cohort of 164 individuals evaluated, only 51 
patients returned to be re-evaluated over a 12-month period.[8]  
In the current literature, no studies have been identified that analyze the effectiveness of 
health education protocols applicable to pulmonary rehabilitation services. To this end, 
we hypothesized that health education strategies offered in rehabilitation services could 
reduce barriers to participation and increase effectiveness in the management of the 
disease. The aim of this study is to evaluate the effects of a proposed educational 
intervention for people with asthma attending the Pulmonary Function Clinic in the city 
of João Pessoa -PB 
 
1.2 Objectives 
 
1.2.1 General Objectives 
 
To evaluate the effects of a proposed educational intervention for people with 
asthma attending the Pulmonary Function Clinic in the city of João Pessoa -PB 
 
1.2.2  Specific Objectives 
 
● Evaluate the effects of an educational intervention protocol on asthma 
knowledge and the correct use of inhalation therapy. 
● Identify the factors associated with knowledge and retention of information 
about asthma. 
● Evaluate the effects of educational interventions on clinical asthma control, 
number of hospitalizations and emergency room visits in the last four months. 

● Evaluate the effects of an educational intervention protocol on the pulmonary 
function of people with asthma. 
 
2. METHODS 
 
2.1 Ethical Aspects 
 
The project was submitted for consideration by the Research Ethics 
Committee (CEP) in accordance with Resolution 466/12 of the National Health 
Council, obtaining a favorable opinion under number 6.968.418. Before beginning the 
implementation of this protocol, the study will be registered with ClinicalTrials.gov (the 
U.S. National Health Service Institute). 
Participation in the study will be on a voluntary basis, with orientation about 
the experiment and the signing of a Free and Informed Consent Form - TCLE. 
Individuals will be informed that participation in the study is not 
compulsory, that there will be no financial costs and that they will remain anonymous in 
relation to the data collected. They will also be free to refuse to participate or to 
withdraw their consent at any stage of the study without penalty or reprisals. 
In the event of any changes in the alignment of the protocol or in the 
development of the project, participants will be formally informed via the telephone 
contact previously provided. 
 
2.2 Trial design 
 
This is a randomized controlled clinical trial conducted in accordance with 
the recommendations of the CONSORT guideline.[11] 
 
2.3 Population 
 
The population of this study will consist of people with a clinical diagnosis 
of asthma made by a medical professional, considering the following criteria: (i) 
presence of respiratory symptoms, such as wheezing, shortness of breath, chest 
tightness and cough, which vary with time and intensity, together with (ii) variable 
limitation of expiratory airflow. Asthma control and severity will be assessed following 

the recommendations of GINA (2024).[1] 
 
2.4 Sampling and Allocation Process 
 
The sample will be made up of patients attending the Pulmonary Function 
Clinic of the Physiotherapy Department at UFPB.  The pulmonary function outpatient 
clinic is a university extension project offering free care to the community, run by the 
Cardiorespiratory Physiotherapy Research Laboratory - LAFIPCARE of the UFPB 
Physiotherapy Department. 
This study will be conducted according to the following design: One 
researcher (researcher 1) will be responsible for the confidentiality of the allocation. 
One researcher (researcher 2) will be responsible for randomization. A third researcher 
(researcher 3) will apply the educational intervention protocol and a fourth researcher 
will carry out the statistical analysis. 
The allocation will be concealed using sealed, opaque envelopes, numbered 
consecutively. Each participant will be represented by a numerical code determined by 
researcher 1.  
Individuals will be recruited non-probabilistically and randomly assigned to 
one of two groups (experimental or control) via the website www.randomization.com. 
Due to the nature of the intervention, only the researchers responsible for 
each stage of the study will be blinded in the development of this research.  
 
 
2.5 Sample calculation 
 
 
For sample size calculation, the main outcome considered was the clinical 
control of asthma (ACT/c-ACT), with the following statistical parameters: a 
significance level of 5%, a power of 80%, and a minimally important clinical difference 
of +3 points, totaling a sample of 28 individuals, with 14 in each group. 
 
2.6 Inclusion Criteria 
 
 
The study will include people with a clinical diagnosis of asthma 3, assisted 

by the Pulmonary Function Clinic, who have ventilatory dysfunction assessed by 
spirometry. 
 
2.7 Exclusion criteria 
 
 
The study will exclude users who are obese, undergoing treatment with systemic 
corticosteroids; have undergone previous chest surgery; and are unable to perform any 
of the proposed assessment steps. 
 
2.8 Selection of Participants 
 
Recruitment 
 
The sample will be made up of people with a clinical diagnosis of asthma, 
assisted by the Pulmonary Function Clinic of the Physiotherapy Department of UFPB, 
who meet the eligibility criteria. 
 
2.9 Measuring instruments and procedures 
 
 
A standardized assessment form will be used to collect personal, 
sociodemographic and anthropometric data. The questionnaire proposed by Angelini et 
al.(2009) [8] will be used to assess knowledge about asthma and correct mastery of 
inhalation therapy (Appendix 1). The number of correct answers will be counted to 
quantify asthma knowledge. 
Clinical control of the disease will be assessed using the Asthma Control 
Test (ACT) questionnaire (Appendix 2) and C-ACT. Participants will also be assessed 
on the number of asthma attacks, the amount of medication used, hospitalizations and 
emergency room visit in the last 4 weeks. Evaluations will be carried out at the first 
contact (baseline) and four weeks after the first contact. 
The study participants will be allocated into two groups. The individuals 
allocated to the control group will receive standard follow-up according to the clinic's 
routine. Patients allocated to the experimental group will undergo a BUNDLE 
educational intervention, designed in accordance with the recommendations of the 
Global Initiative for Asthma - GINA (2024) [1], as shown in Table 1. 

 
Asthma Control Test (ACT) 
 
 The ACT will be used to assess the clinical control of asthma. It is a simple 
instrument, with adequate validity and reproducibility (cronbach's alpha: 0.93), easy to 
apply, consisting of five questions referring to the last four weeks, among which there 
are five possible answers, with each answer corresponding to a score.The higher the 
score, the greater the asthma control[13]. 
 
Childhood Asthma Clinical Control Test - (c-ACT) 
 
The Children's Asthma Clinical Control Test (c-ACT) is one of the most 
clinically used instruments for assessing asthma control in children up to 11 years old. It 
is a simple questionnaire, easy to apply, with adequate validity and reproducibility 
(Cronbach's alpha: 0.677), translated and validated for Brazilian children by Oliveira et 
al., (2016). [14] 
 The questionnaire stands out for containing items considered fundamental 
standards for assessing asthma control at the outpatient level, and can be applied in 
primary and observational research. It is an instrument made up of seven short-answer 
questions, the first four of which are answered by the child being assessed and ask about 
their own perception of their current asthma control, restrictions on their activities and 
sleep disturbances during the night. To answer these questions, the children must 
choose one of four children's faces that represent emotions on a scale from sad to happy. 
[14] 
The remaining three questions are answered by a parent or legal guardian 
and ask about the child's respiratory symptoms (asthma symptoms during the day, 
wheezing episodes and night waking) in relation to the period prior to 4 weeks. At the 
end of the questions, the assessed child is given a score, with a cut-off point below 19 
being considered indicative of uncontrolled asthma. [14] 
 
 
Pulmonary Function Evaluation - Spirometry 
Spirometry is considered the classic test for assessing lung function, widely 
recommended and applicable in care practice. This project will initially use the 

SPIROSTIK, Geratherm® spirometer. This instrument follows the recommendations 
imposed by the Brazilian Society of Pneumology, the American Thoracic Society and 
the European Respiratory Society. [15]  
A mouthpiece and a bactericidal filter will be attached to the device, which 
will be exchanged between each participant. In order to prevent air escaping, all 
measurements will be carried out with the patient wearing a nose clip and they will be 
instructed to clamp the mouthpiece with their teeth and adjust their lips around it 
properly.  
The evaluators will receive prior training and will be wearing all the 
personal protective equipment necessary to prevent contact with fluids or aerosols in 
order to minimize risks, such as contamination with COVID-19. Spirometry 
measurements will be carried out following the protocol of the American Thoracic 
Society and the European Respiratory Society. [16, 17] 
 Patients with obstructive ventilatory dysfunction, with a reduction in the 
predicted values of FEV1 and FEV1/FVC, will be submitted to a bronchodilator test 
(Salbultamol ∕Aerolin ® 100 µg, 4 jets at an interval of 30 seconds each, sustained to 
total lung capacity -CPT- for 10 seconds between each inspiration). A new pulmonary 
function test will be carried out 15 minutes after administration of the drug.  
During the test, patients will remain seated, wearing the nose clip and with 
their head in a neutral position. To perform the test, the patient will be asked to inhale 
deeply as far as possible, take a minimum pause (1-2 seconds) and then blow out with 
maximum effort and continue with maximum exhalation until the end of the test.  
The maneuvers will be carried out according to the following protocol: 1) 
maximum inspiration before the start of the test; 2) minimum pause (1-2 seconds); 3) 
expiration with maximum effort; 4) maximum inspiration; 5) absence of artifacts, such 
as coughing in the first second, leakage, obstruction of the mouthpiece, Valsalva 
maneuver, closure of the glottis, hesitation during the maneuver, new inspiration during 
the maneuver. 
Patients should have a volume-time curve that shows no change in volume 
greater than/equal to 0.025 l during the last second (plateau); a satisfactory test duration 
(six seconds); and to ensure that the forced expiratory volume in the first second 
(FEV1) will be performed in a curve with maximum effort, the back-extrapolated 
volume should be 5% of the forced vital capacity (FVC) or 0.150l, whichever is greater.  

A minimum of 3 and a maximum of 8 maneuvers will be performed to 
obtain 3 acceptable maneuvers (using the criteria mentioned above) and with a 
maximum difference of 0.150L (for FVC values above 1 liter) or 0.1L (for FVC values 
below 1 liter) between the two largest maneuvers, with the largest measurements from 
the two tests being chosen. 11 One minute's rest will be given between each maneuver 
and the flow-volume and volume-time curves will be analyzed for each maximum 
effort. Among the acceptable and reproducible curves, the values of FEV1, FVC, 
Tiffeneau index (FEV1/FVC) and peak expiratory flow (PEF) will be selected, which 
can be taken from different curves and the value of forced expiratory flow between 25% 
and 75% of FVC (FEF25-75%), selected from the curve with the highest sum between 
FVC and FEV1.  
 
BUNDLE of Educational Intervention 
 
Bundles are defined as a set of interventions or clinical actions that, when 
carried out reliably, can improve patient outcomes. The British Thoracic Society (BTS) 
has observed that the implementation of bundles within asthma patient care has reduced 
the number of hospitalizations due to exacerbation of the disease.[18] 
The educational intervention bundle was drawn up in accordance with the 
recommendations of GINA (2024) [1], and will cover topics on the etiopathogenesis 
and pathophysiology of asthma, inhaler treatment, precipitating factors for crises, self-
management skills, environmental control, as well as the importance of drawing up a 
written therapeutic plan and regular medical follow-up (Chart 1).  
The educational intervention will be offered as a group activity and will be 
conducted in a single meeting, lasting approximately sixty minutes. Users will attend a 
standardized dialogical lecture using audiovisual resources, where they will have the 
opportunity to discuss and answer any questions related to the topics covered. At the 
end of the intervention, participants will receive a booklet containing all the points 
covered in the intervention, as well as a diary to record the amount of medication used, 
visits to the emergency room and asthma-related hospitalizations. This approach will 
provide a comprehensive view of the effectiveness of the intervention and the 
participants' commitment to the protocol. 
 
 

Chart 1. BUNDLE of Educational Intervention 
Content 
Activity objectives 
1. Etiopathogenesis and 
Pathophysiology of 
Asthma 
1. Present the structures and functions related to the respiratory 
system. Report on the functional importance of this system, as 
well as identifying the alterations and symptoms present in 
individuals with asthma; 
 
2. Inhaler treatment 
2. Identification of the drugs commonly used in the treatment of 
asthma, as well as the route of administration;  
Simulated practical activity on how to use the pressurized 
nebulizer, emphasizing the importance of the spacer; 
 
3. Precipitation factors for 
crises and self-
management skills 
 
3. Recognize the factors that trigger bronchospasm attacks and the 
onset of symptoms related to asthma attacks; 
4. Strategies for 
environmental control 
4. Know the environmental control strategies needed to prevent 
asthma attacks; 
 
5. Written therapeutic plan 5. Learn about the need for access to a written, completed, guided 
and individualized therapeutic plan.  The importance of the 
therapeutic plan in the management of treatment, symptom control 
and guidance on what to do in the event of an exacerbation. 
 
6. Periodic medical 
follow-up 
6. Learn about the need for regular medical monitoring and 
pulmonary function tests. 
 
 
RISKS AND BENEFITS 
 
This study presents minimal foreseeable risks. Among the possible risks, we 
would highlight the possibility of some kind of embarrassment during the 
sociodemographic questionnaires, and if this occurs, the individuals will be informed 
that their answers are not obligatory. During the pulmonary function tests, patients may 
experience mild symptoms of dizziness or shortness of breath. If this occurs, the tests 
will be suspended immediately. 
2.9 Benefits 
 
Participants in the study will receive specialized assessments that will 
enable more assertive multidisciplinary follow-up, allowing for greater agility and 
appropriate therapeutic management. In addition, the study aims to contribute to a better 
understanding of the effectiveness of educational intervention strategies for people with 
asthma, which could help in the future to identify barriers and facilitators associated 

with knowledge retention and adherence and to develop health education strategies for 
other chronic respiratory diseases. Furthermore, this study will be available to society 
and could serve as a basis for future clinical trials. The researcher in charge will have 
access to the set of duly organized and processed data generated by the project. 
 
 
 
2.10 Statistics analysis 
 
The data will be analyzed using the Statistical Package for the Social 
Sciences (SPSS) software, version 23.0 (SPSS, Chicago, IL, USA). Initially, the 
normality of the data will be tested using the Kolmogorov-Smirnov test. If a parametric 
distribution is observed, the data will be described using the mean and standard 
deviation. Variables with a non-parametric distribution will be presented as medians 
and interquartile ranges. Categorical variables will be described as relative and absolute 
frequencies.   
The paired t-test or its non-parametric counterpart, Wilcoxon, will be used 
to compare the values obtained before and after the intervention, relating to (i) the 
number of correct answers about asthma knowledge and inhaler medication, (ii) 
emergency room visits, (iii) the number of hospitalizations, (iv) clinical asthma control 
(ACT/c-ACT).   
Retention of information about knowledge of asthma and inhalation therapy 
will be analyzed using the number of correct answers obtained from the questionnaire at 
the end of the educational intervention at each visit. The relationship between the 
number of correct answers and the categorical variables will be assessed using Student's 
t-test or ANOVA, depending on the number of categories of the variables. 
Then, a multiple linear regression analysis (Stepwise method) will be 
carried out between the independent variables to assess which are capable of 
determining the variation in the number of correct answers (retention and knowledge of 
asthma and inhalation therapy). For each outcome, the covariates with p <0.20 in the 
bivariate analysis will be used in the regression.  Variables with p <0.05 will be 
considered and retained in the final model.  
Variables with missing values of less than 20% will be analyzed by 
intention to treat. 24 To assess the magnitude of the effect in the group (pre- vs. post-
intervention) and between the groups (experimental vs. control) in the post-intervention 

period, the Effect Size (ES) will be calculated using Cohen's method, applying the ratio 
between the mean difference between the groups and the pooled standard deviation. The 
reference values for defining the TE will be: small = 0.21-0.49; medium = 0.50-0.79; 
high = >0.80. 25 The percentage change (Δ%) will be expressed as the difference 
between the mean values obtained pre- and post-intervention, in percentage form 
relative to the pre-intervention mean. A significance level or p-value <0.05 and 95% 
confidence intervals will be used for all tests. 
 
3. 
MAIN CONTRIBUTIONS AND PERSPECTIVES OF THE STUDY 
 
The recommendations for asthma management and control state that 
educational interventions are associated with better knowledge and control of the 
disease, resulting in lower hospitalization rates and lower public health costs.3 Despite 
these recommendations, there are few references in the current literature regarding 
protocols for educational interventions for people with chronic respiratory diseases.  
This study aims to contribute to a better understanding of the effectiveness 
of educational intervention strategies for people with asthma. From this perspective, the 
results of this research may in future help to identify barriers and facilitators associated 
with retaining and adhering to users' knowledge about asthma, with a view to serving as 
a precursor in the development of health education strategies for other chronic 
respiratory pathologies. 
In this perspective, this study aims to corroborate the process of generalist, 
humanist, critical and reflective academic training, based on local aspects with 
important contributions to society.  This study aims to stimulate partnerships between 
the Physiotherapy Department of the Federal University of Paraíba and other 
departments, institutions and other social actors, with a view to expanding knowledge 
and physiotherapeutic practices in the area of respiratory and cardiovascular 
physiotherapy based on scientific evidence. 
 
 
REFERENCES 
 
 
  
1.  
GINA (2024) Global Strategy for Global Strategy for Asthma Management and 

Prevention. Glob Initiat Asthma 1–201 
2.  
Pereira EDB, Cavalcante AGM, Pereira ENS, Lucas P HM (2011) Controle da 
asma e qualidade de vida em pacientes com asma moderada ou grave. J Bras 
Pneumol 37:705–711 
3.  
Sociedade Brasileira de Pneumologia e Tisiologia S (2012) Diretrizes da 
Sociedade Brasileira de Pneumologia e Tisiologia para o Manejo da Asma - 
2012. J Bras Pneumol e Tisiol 38:S1-46 
4.  
DATASUS DATASUS. Portal da Saúde. Brasília: Ministério da Saúde. 
Indicadores e dados básicos. [Internet]. Available from: 
http://tabnet.datasus.gov.br.  
5.  
Solé D, Camelo-Nunes IC, Wandalsen GF, Naspitz CK, Vanna AT, Amorim A  
et al (2004) Is asthma in Brazilian children a public health problem? Rev Bras 
Alerg 27:185–188 
6.  
Urrutia-Pereira, M; Avila, J;Solé D (2016) The Program for the Prevention of 
Childhood Asthma: a specialized care program for children with wheezing or 
asthma in Brazil. J Bras Pneumol 42:42 
7.  
Coelho, ACC; Cardoso, LSB; Souza-Machado CSo-MA (2016) The Impacts of 
Educational Asthma Interventions in Schools: A Systematic Review of the 
Literature. Can Respir J. https://doi.org/10.1155/2016/8476206 
8.  
Angelini L, Robles-ribeiro PG, Carvalho-pinto RM De, Ribeiro M, Cukier A, 
Stelmach R (2009) Two-year evaluation of an educational program for adult 
outpatients with asthma. J Bras Pneumol 35:618–627 
9.  
Wolf F, Guevara JP, Grum CM, Clark NM, Cates CJ (2002) Educational 
interventions for asthma in children. Cochrane Database Syst Rev. 
https://doi.org/10.1002/14651858.cd000326 
10.  
Schuermans D, Hanon S, Wauters I, Verbanck S, Vandevoorde J, Vanderhelst E 
(2018) Impact of a single 10 min education session on asthma control as 
measured by ACT. Respir Med 143:14–17 
11.  
Bourtron I, Altman DG, Moher D, Schultz KF RP (2017) CONSORT Statemend 
for Randomized Trials of Nonpharmacoligic Treatments: A 2017 Update and a 
CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 
https://doi.org/10.7326 
12.  
Lwanga SK LS (1991) Sample size determination in health studies: a practical 
manual. World Heal. Organ.  

13.  
Roxo JPF, Ponte EV, Ramos DCB, Pimentel L, Júnior ADO CA (2010) 
Portuguese-language version of the Asthma Control Test: validation for use in 
Brazil. J Bras Pneumol 36:159–166 
14.  
Oliveira SG, Sarria EE, Roncada C, Stein RT, Pitrez PM MR (2016) Validation 
of the Brazilian version of the childhood asthma control test (c-ACT). Pediatr 
Pulmonol 51:358–363 
15.  
Polgar D (2002) Comparação entre os valores teóricos para alguns dados 
espirométricos em crianças determinados pelas equações de Mallozi e de Polgar 
*. 28:125–130 
16.  
Graham BL, Steenbruggen I, Barjaktarevic IZ, et al (2019) Standardization of 
spirometry 2019 update an official American Thoracic Society and European 
Respiratory Society technical statement. Am J Respir Crit Care Med 200:E70–
E88 
17.  
CAC P (2002) Espirometria. J Bras Pneumol 28:S1–S82 
18.  
Society B (2016) Improving Outcomes in Asthma British Thoracic Society 
Asthma Care Bundle .  
 
PROJECT MEMBERS 
 
Prof. Dra. Renata R. Tomaz Barbosa (Coordinator) 
Prof Dra. Socorro Gadelha (Associate coordinator) 
Prof Dra. Tatiana Onofre (Advisor) 
Prof Dr. José Hariston 
Prof Dr Eduardo Érico 
Prof Dr Rafaela Pedrosa 
Sandyelle Teixeira Vieira – Specialist external to UFPB 
Alana Vitória Mescias da Silva 
Camilly Garcia De Souza Gomes 
Maria Eduarda Farias 
Aline Gonçalves de Carvalho 
Maria Gabriela Martins dos Santos 
Ana Beatriz Gomes de Lima 
Jullyana Chagas da Silva 
José Anderson Marques dos Santos 

Vitória Freire Alves 
Beatriz de Freitas Araújo  
Felipe Alves do Nascimento  
 
 
 
 
 
TIMETABLE 
 
ACTIVITIES 
2024 
2025 
JUN/
JUL 
AGO/
SET 
OUT 
NOV 
DEZ 
FEV/
MAR 
ABR
/MA
I 
JUN/
JUL 
AGO 
SET 
OUT 
Creation and consolidation of a 
research group with undergraduate 
students and collaborations with 
other teachers 
 
 
 
 
 
 
 
 
 
 
 
Updating 
the 
Theoretical 
Framework 
 
 
 
 
 
 
 
 
 
 
 
Project submission to Plataforma 
Brasil 
 
 
 
 
 
 
 
 
 
 
 
Training 
and 
methodological 
discussion with team members 
 
 
 
 
 
 
 
 
 
 
 
Patient recruitment 
 
 
 
 
 
 
 
 
 
 
 
Application 
of 
the 
educational 
intervention protocol 
 
 
 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
 
Presentation of partial data - writing 
scientific articles with cross-
sectional data. 
 
 
 
 
 
 
 
 
 
 
 
Writing scientific articles 
 
 
 
 
 
 
 
 
 
 
 
Presentation of papers at national 
and international congresses and 
journals 
 
 
 
 
 
 
 
 
 
 
 
Activity report 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

APPENDICES 
APPENDICE 1- Questionnaire to assess asthma knowledge and mastery of inhaler 
technique 
  
Assessment of clinical improvement 
 
How many times have you had to go to the emergency in the last month because of 
asthma? 
0 ( ) 1 ( ) 2 ( ) 3 ( ) 4 ( ) more than 4 times ( )  
How many days have you had to take a corticosteroid tablet in the last month, e.g. 
Meticorten/Prednisone? 
0 ( ) 1 ( ) 2 ( ) 3 ( ) 4 ( ) more than 4 times ( ) 
How many times have you been unable to go to work or school or do your homework  
because of asthma in the last month? 
0 ( ) 1 ( ) 2 ( ) 3 ( ) 4 ( ) more than 4 times ( ) 
 
 
 Pathophysiology and environmental control 
 
What do you think is wrong with the lung? 
Asthma ( ) Bronchitis ( ) Both ( ) 
What is asthma to you? 
( ) I do not know 
( ) is a contagious disease 
( ) is a disease you can catch from contact with a cat 
 ( ) is an inflammation of the bronchi 
( ) is an infection in the bronchi 
 
What is bronchospasm, when you wheeze or feel tightness in your chest? 
 ( ) is do not know 
 ( ) closing the air path in the bronchi 
 ( ) clogged lungs 
 ( ) dirt in the lungs  
( ) lung infection 
Do you think someone could die from asthma?   
Yes ( ) No ( ) 
 
Check what could cause a person to have an asthma attack: 
 
cigarette smoke ( ) animal hair ( )   
cleaning product ( ) weather change ( ) 
strong perfume/smell ( ) dust and/or pollution ( ) 
mold/smell ( ) pregnancy ( ) 
food ( ) emotion/rage/sadness ( ) 
menstruation ( ) laughter ( ) 
flu/cold ( ) medicine ( ) physical exertion ( ) 
 
Mark on the line how important it is to take care of the place where you live so that you 
don't have any more asthma attacks. (As if you were going to give a score from 0 to 10, 

by ticking a box on the line). 0 ____________________________________ 10 
 
 
Treatment and inhalation technique  
What are bronchodilators used for in asthma? 
 ( ) I don't know  
( ) it's a medication to open up the bronchi 
 ( ) it's a medication to improve inflammation  
( ) is a medication that speeds up the heart 
What are corticosteroids used for in asthma? 
 ( ) I don't know  
( ) it's a medication to make the crisis go away 
 ( ) it's a medication to treat inflammation 
 ( ) it's a medication that makes you swollen  
Do you think that corticosteroids: 
 ( ) can make you dependent  
( ) can be bad for your heart 
 ( ) should be used when an asthma attack starts 
 ( ) should be used to prevent asthma attacks 
Do you know how to use your spray and/or powder medication?  
Yes ( ) No ( ) 
 
CHECK THE USE OF THE MEDICATION (the patient is asked to demonstrate how 
they normally use two doses of the medication with placebo devices; the educator 
checks and marks what they have done, following the list below). 
 
With spacer ( ) 
Take the cap off the pump ( )  
Fit the spacer ( ) 
Shake the pump ( ) 
Releases all the air before putting the pump in the mouth ( ) 
Fires a jet from the pump ( ) 
Pulls the medicine out slowly with the mouth open ( ) 
Holds breath after pulling the medicine ( ) 
Counts to 10 and then releases the air ( ) 
Waits a minute to shoot another jet ( ) 
 
Without spacer ( ) 
Take the cap off the pump ( ) 
Shake the pump ( )  
Leave space between the pump and the mouth ( ) 
Release all the air before putting the pump in the mouth ( )  
Shoots a jet from the pump ( ) 
Pulls the medicine out slowly with your mouth open ( ) 
Holds breath after pulling the medicine ( ) 
Counts to 10 and then releases the air ( ) 
Waits a minute to shoot another jet ( ) 
 
 
 

APPENDICE  2. Asthma Control Test - ACT 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
FEDERAL UNIVERSITY OF PARAIBA-UFPB 
HEALTH SCIENCE CENTER 
PHYSIOTERAPY CENTER 
 
INFORMED CONSENT FORM – TCLE 
(Resolution of nº. 466/2012) 
 
 Dear Sir or Madam, 
This research project is entitled “Impact of an educational intervention protocol on the level of 
knowledge, clinical control and pulmonary function of people with asthma: a randomized controlled 
clinical trial”. This project is being carried out by students of Physiotherapy at the Federal University of 
Paraíba, for the purposes of study and preparation of academic work under the guidance of Professor Dr. 
Renata Ramos Tomaz Barbosa, Professor Dr. Maria do Socorro Nunes Gadelha and Professor Dr. Tatiana 
Onofre.   
The aim of this project is to optimize therapeutic strategies and resources for adults and children 
with chronic respiratory diseases. It also aims to increase clinical control, reduce the risk of exacerbations 
and hospitalizations, and enable targeting and access to pulmonary rehabilitation services, with a view to 
promoting comprehensive and resolutive care. The participation of volunteers will be essential, as the 
information collected will be analyzed and may result in the development of measures to prevent 
respiratory diseases. We ask for your cooperation in filling in an assessment form containing questions 
about living conditions, the level of education of caregivers and economic issues, and a physiotherapy 
assessment based on the information in the medical records. We request your authorization to present the 
results of this study at health events and to publish in a national and/or international scientific journal. 
The data relating to identification will not be published, preserving the privacy of the volunteers, where 
there will be no type of exposure for the user of the system and their guardians. When the results are 
published, your name will be kept strictly confidential. We would like to inform you that this study poses 
no risk to the health of any of the participants. This study presents minimal foreseeable risks. Among the 
possible risks, we highlight the possibility of some kind of embarrassment during the application of the 
sociodemographic questionnaires, and if this occurs, the individuals will be informed that their answers 
are not obligatory. During lung function tests, patients may experience mild symptoms of dizziness or 
shortness of breath. If this occurs, the tests will be suspended immediately.  
We would like to clarify that your participation is voluntary and therefore you are not 
obliged to provide the information and/or collaborate with the activities requested by the researcher. If 
you decide not to take part in the study, or decide to withdraw from it at any time, you will not suffer any 
harm, nor will there be any changes to the care you have been receiving at the institution.  
 
INFORMED CONSENT FORM: Considering that I have been informed of the objectives and 
relevance of the proposed study, how I will participate, the procedures and risks arising from this project, 
I declare my consent to participate in the research, as well as agreeing that the data obtained in the 
investigation will be used for scientific purposes (dissemination at events and publications). I am aware 
that I will receive one copy of this document. 
By signing at the end of this document, YOU, voluntarily, as a PARTICIPANT of the research, express 
your free and informed consent to take part in this study and declare that you are sufficiently informed, in 
a clear and objective manner, about this investigation. And you will receive a copy of this Informed 
Consent Form (ICF), signed by the Researcher in Charge.  
 
João Pessoa, ____ de________________ de ______ 
____________________________________________ 
Signature, in full, of the Research Participant 
 
Prof Dra Renata R. Tomaz 
 
Signature, in full, of the researcher responsible for the research. 
 
The researchers will be at your disposal for any clarification you may deem necessary at any stage of the research. 
 
Contact Information: 
• 
Principal and Other Members of the Research Team: 
 
WATER 
MARK 

Supervisor: Profa Dra Renata R. Tomaz Barbosa 
E-mail: renatatomazf@gmail.com // Phone:   (83) 9935-1535   Branch: 3217183 
Physiotherapy Department/CCS/UFPB 
• 
Research Ethics Committee Adress and Contact Information (CEP)/CCS/UFPB. Research Ethics Committee (CEP) 
Health Science Center (1º floor) of Federal University of Paraíba Campus I – Cidade Universitária / CEP: 58.051-900 – 
João Pessoa-PB Phone: +55 (83) 3216-7791 // E-mail: comitedeetica@ccs.ufpb.br    Opening Hours:  07h to 12h and 13h 
to 16h.  Homepage: http://www.ccs.ufpb.br/eticaccsufpb