AsthmaNCT06878352
Impact of Educational Intervention Protocol on the Level of Knowledge, Clinical Control and Lung Function of People With Asthma
A study testing Educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024)). in people with Asthma, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
The goal of this randomized controlled clinical trial is to evaluate the effects of a proposed educational intervention on people with asthma. The main question it aims to contribute to a better understanding of the effectiveness of educational intervention strategies in people with asthma. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024)).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of asthma
- Assisted by the Pulmonary Function Clinic
- Ventilatory dysfunction assessed by spirometry
Who cannot join
- Obesity
- Treatment with systemic corticosteroids
- Previous chest surgery
- Unable to perform any of the proposed assessment steps
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Paraiba
João Pessoa, Paraíba, 58051-900
Renata Tomaz, PhD, 5583999351535, renatatomazf@gmail.com
About this study
Official title: Impact of Educational Intervention Protocol on the Level of Knowledge, Clinical Control and Lung Function of People With Asthma: Randomized Controlled Clinical Trial
The goal of this randomized controlled clinical trial is to evaluate the effects of a proposed educational intervention on people with asthma. The main question it aims to contribute to a better understanding of the effectiveness of educational intervention strategies in people with asthma.
Participants allocated to the control group will receive standard follow-up according to the clinic routine. Participants 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).
Read the detailed description
People with asthma will participate in the study, from the Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Paraíba - UFPB. Spirometry data, knowledge about asthma and correct control over inhalation therapy, clinical control of the disease using the Asthma Control Test (ACT) and 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 twelve weeks after the first contact.
- Conditions
- Asthma
- Being tested
- Educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024)).
- Keywords
- Asthma, Heath Education, Spirometry, Respiratory Tract Disease
- Medical subject headings
- Asthma, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024)).Other
Also called Health Education, Educational Intervention, Bundle
The educational intervention bundle was designed in accordance with the recommendations of GINA (2024), 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | The control group will receive standard follow-up according to the clinic routine. |
| Educational intervention BUNDLE | Experimental | The experimental group will undergo an educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024), 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. Receives: Other: Educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024)). |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical asthma control
Asthma Control Test (ACT)/Childhood Asthma Control Test (C-ACT) score. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
Measured: Baseline and 4 weeks
Retention of information about asthma knowledge and inhalation therapy
Number of correct answers obtained from the asthma knowledge questionnaire at the end of the educational intervention
Measured: Baseline and 4 weeks
Secondary outcomes (2)
hospitalizations and emergency room visits
number of hospitalizations and emergency room visits in the last four months
Measured: Baseline and 4 weeks
Pulmonary function - Spirometry
Predicted percentages of spirometric variables such as the values of Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) because the correlation between these values can indicate the presence of respiratory disorders such as asthma.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Ramos Tomaz Barbosa, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878352
- Sponsor's protocol ID
- 6.968.418
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Educational Intervention Protocol on the Level of Knowledge, Clinical Control and Lung Function of People With Asthma: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06878352
- Acronym / sponsor ID
- 6.968.418
- Conditions
- Asthma
- Keywords
- Asthma, Heath Education, Spirometry, Respiratory Tract Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled clinical trial is to evaluate the effects of a proposed educational intervention on people with asthma. The main question it aims to contribute to a better understanding of the effectiveness of educational intervention strategies in people with asthma.
Participants allocated to the control group will receive standard follow-up according to the clinic routine. Participants 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).
Detailed description
People with asthma will participate in the study, from the Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Paraíba - UFPB. Spirometry data, knowledge about asthma and correct control over inhalation therapy, clinical control of the disease using the Asthma Control Test (ACT) and 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 twelve weeks after the first contact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –The control group will receive standard follow-up according to the clinic routine. |
| Educational intervention BUNDLE | Experimental | Other: Educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024)).The experimental group will undergo an educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024), 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of asthma
- Assisted by the Pulmonary Function Clinic
- Ventilatory dysfunction assessed by spirometry
Key exclusion criteria (4 listed)
- Obesity
- Treatment with systemic corticosteroids
- Previous chest surgery
- Unable to perform any of the proposed assessment steps
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024)).Also: Health Education, Educational Intervention, BundleThe educational intervention bundle was designed in accordance with the recommendations of GINA (2024), 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. 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. | Other | Educational intervention BUNDLE |
Primary outcome
clinical asthma control
Time frame: Baseline and 4 weeks
Asthma Control Test (ACT)/Childhood Asthma Control Test (C-ACT) score. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
Retention of information about asthma knowledge and inhalation therapy
Time frame: Baseline and 4 weeks
Number of correct answers obtained from the asthma knowledge questionnaire at the end of the educational intervention
2 secondary outcomes
hospitalizations and emergency room visits
Time frame: Baseline and 4 weeks
Pulmonary function - Spirometry
Time frame: Baseline and 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pulmonary Function Clinic of the Department of Physiotherapy at Federal University of Paraiba
João Pessoa, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention BUNDLE, prepared in accordance with the recommendations of the Global Initiative for Asthma- GINA (2024)). in people with Asthma, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical asthma control (time frame: Baseline and 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.