AsthmaNCT06061497
Effectiveness of the Rehabilitation Nursing Consultation for People With Asthma on Symptom Control and Quality of Life
A study testing Abdomino-diaphragmatic breathing in people with Asthma and Rehabilitation, run by ACES Entre Douro e Vouga II - Aveiro Norte at 1 site in Portugal.
Trial summary
Introduction Asthma is a chronic inflammatory disease of the respiratory airways and is considered a Public Health problem, which lacks a personalized multidisciplinary intervention, to allow the user to develop mastery in the self-management of his disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, Rehabilitation, Breathing, Mouth
- What is being tested?
- Abdomino-diaphragmatic breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 sitePortugal
- Study dates
- 3 Jul 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of asthma, with R96 coding according to ICPC2;
- Users enrolled in health units in the municipality of Oliveira de Azeméis.
Who cannot join
- Impossibility of contacting the user to schedule the appointment;
- Users with severe cognitive dysfunction or psychiatric illness with interference in memory and adherence;
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Portugal1 site
ACES Entre Douro e Vouga II- Aveiro Norte
Oliveira de Azeméis, Aveiro District, 3720-287
About this study
Official title: Effectiveness of a Rehabilitation Nursing Consultation for People With Asthma
Introduction Asthma is a chronic inflammatory disease of the respiratory airways and is considered a Public Health problem, which lacks a personalized multidisciplinary intervention, to allow the user to develop mastery in the self-management of his disease. The project intends to answer the question: What methods could be used to enhance the use of asthma controller therapy? Methods Randomized and controlled clinical trial. The sample consists of users with asthma at Family Health Units in the municipality of Oliveira de Azeméis. There will be an experimental group that will undergo structured rehabilitation nursing consultations, and a control group that will receive the usual nursing care appropriate for asthma management.
Both groups will be subject to two evaluation moments with the CARAT test and the AQLQ-M questionnaire. Results The aim is to evaluate the effectiveness of interventions for people with asthma implemented within the framework of a structured rehabilitation nursing consultation. The investigators expected to observe a clinically significant improvement with regard to disease control, quality of life, and user empowerment.
Read the detailed description
By carrying out this study, the following aims are intended to be achieved:
Main Goal To evaluate the effectiveness of rehabilitation nursing interventions in adults with asthma in controlling symptoms and quality of life. Specific Goals To evaluate the symptomatic improvement, comparing the initial and final evaluation.
To evaluate the quality of life related to health, comparing the initial and final evaluation after consultations, using the Asthma Quality Of Life Questionnaire by Marks (AQLQ-M); To achieve the proposed objectives, the investigators started with the following question: What are the effects of a structured rehabilitation nursing consultation on asthma control and healthrelated quality of life? To answer this question, a randomized and controlled clinical trial will be carried out, with the intention of studying the effectiveness of the interventions under study, comparing them with usual care. The population under study are people with asthma, the sample being made up of adults with asthma, enrolled in the ACeS Entre Douro e Vouga II, belonging to the municipality of Oliveira de Azeméis. The sample will be consecutive non-random.
Participants will be randomly assigned to one of 2 groups, intervention or control. The encryption key will be prepared using MS Excel and will be filed in a closed cabinet under the responsibility of the principal investigator. The minimum necessary sample size was calculated considering the final comparison between the two groups. Therefore, stipulating the T test for independent samples as the procedure to be used, or the corresponding non-parametric Mann-Whitney U test, a significance level of 5%, a test power (1-β) of 80%, an effect magnitude high, the sample size to be collected will be 102 participants, which corresponds to 51 participants per group. Considering that the investigators may have 20% of follow-up losses, the sample size to be collected will be 102 participants (51 per group). Participants in both groups will be subject to two evaluation moments, an initial one during the first contact and another at the end of the intervention.
The following variables will be studied:
Independent variable Structured rehabilitation nursing consultation for people with asthma.
Main dependent variable:
- Asthma control - assessed with the Asthma and Allergic Rhinitis Control Test (CARAT) Secondary dependent variables
- Quality of life - assessed with the Asthma-Related Quality of Life Questionnaire (AQLQ - M)
- User empowerment - assessed with mPEI modified Patient Enablement Instrument. Intervention Both groups will have access to the health care recommended in the Integrated Care
Process for Asthma in Children and Adults, of the DGS, namely:
- Education for health;
- Inhalation technique;
- Adherence to treatment;
- Presence of comorbidities;
- Smoking;
- Other environmental factors;
- Promotion of physical activity. The rehabilitation nursing consultation will be carried out by the specialist nurse in rehabilitation nursing, at UCC Aveiro Norte, during the year 2023 and will be based on autonomous interventions in the domain of the specialist nurse in rehabilitation nursing, within the scope of training for self-management of asthma, breathing exercises. These interventions are in addition to those implemented in a Nursing consultation, for the person with asthma defined by the DGS and which will be applied in the control group, first consultation and in the fourth week. The Intervention group will be held during four consultations, one per week, where the following interventions will be carried out:
- Breathing awareness and control;
- Postural correction techniques;
- Relaxation techniques and resting positions;
- Airway permeabilization techniques
- Conditions
- Asthma, Rehabilitation, Breathing, Mouth, Nursing Caries, Adult
- Being tested
- Abdomino-diaphragmatic breathing, Usual Care
- Keywords
- Asthma, Nurse, Rehabilitation, Quality of life, Breathing exercises, Clinical Trials, Obstructive airway disease, Non-pharmacological therapy
- Medical subject headings
- Asthma, Mouth Breathing, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdomino-diaphragmatic breathingOther
Breathing should be done twice a day for 10 minutes.
Usual CareBehavioural
Health education Review of inhaler technique Check adherence to treatment; Presence of comorbidities; Smoking; Other environmental factors; Promotion of physical activity
| Study group | Role | What they receive |
|---|---|---|
| Abdomino-diaphragmatic breathing | Experimental | There are four consultations with autonomous rehabilitation nursing intervention: abdomino-diaphragmatic breathing.
In addition to adding the health care that is recommended in the Integrated Care Process for Asthma in Children and Adults, of the Portuguese Directorate-General for Health, namely:
Health education:
Inhalation technique Adherence to treatment; Presence of comorbidities; Smoking; Other environmental factors; Promotion of physical activity. Receives: Other: Abdomino-diaphragmatic breathing; Behavioral: Usual Care |
| Usual care | Placebo comparator | They will have the care recommended in the Integrated Care Process for Asthma in Children and Adults, of the Portuguese Directorate-General for Health, namely:
Health education:
Inhalation technique Adherence to treatment; Presence of comorbidities; Smoking; Other environmental factors; Promotion of physical activity. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Control using the scale Allergic Rhinitis and Control of Asthma Test CARAT
The CARAT questionnaire is composed of 10 questions that address upper and lower airway symptoms, sleep interference, activity limitation, and the need to increase medication over a four-week period. Scores above 24 indicate good disease control.
Upper airway score (item 1-4): 0 Controlled if score >8 Lower airway score (item 5-10): 0 Controlled if score ≥16
Measured: At the first and last consultation in 4 weeks
Quality of life in asthma patients using the scale Mini Ashma Quality of Life Questionnaire (Mini- AQLQ)
This instrument has 15 questions in the same domains as the original AQLQ (symptoms, activities, emotions and environment) and takes 3-4 minutes to complete. An increase of 0.5 in the Mini-AQLQ score is considered a clinically significant improvement.
Measured: At the first and last consultation in 4 weeks
Measure patient enablement in asthma using the scale mPEI
The mPEI is a six-item questionnaire. Each item is scored in a Likert-type scale from 0 ('same or less' or 'not applicable') to 2 ('much better'). There is a minimum score of 0 and a maximum score of 12. A higher score reflects higher patient enablement
Measured: At the last consultation, an average of 4 weeks after the first consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start3 Jul 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACES Entre Douro e Vouga II - Aveiro Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreia Patrícia de Oliveira Santos, ACES Entre Douro e Vouga II - Aveiro Norte
- Investigators
- Andreia Santos, Principal investigator, ACES Entre Douro e Vouga II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061497
- Sponsor's protocol ID
- RehabAsthma
- Status last verified
- Aug 2024
- First submitted
- 9 Sep 2023
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Rehabilitation Nursing Consultation for People With Asthma
- ClinicalTrials.gov ID
- NCT06061497
- Acronym / sponsor ID
- RehabAsthma
- Conditions
- Asthma, Rehabilitation, Breathing, Mouth, Nursing Caries, Adult
- Keywords
- Asthma, Nurse, Rehabilitation, Quality of life, Breathing exercises, Clinical Trials, Obstructive airway disease, Non-pharmacological therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- ACES Entre Douro e Vouga II - Aveiro NorteUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 29 Sep 2023 (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.
Introduction Asthma is a chronic inflammatory disease of the respiratory airways and is considered a Public Health problem, which lacks a personalized multidisciplinary intervention, to allow the user to develop mastery in the self-management of his disease. The project intends to answer the question: What methods could be used to enhance the use of asthma controller therapy? Methods Randomized and controlled clinical trial. The sample consists of users with asthma at Family Health Units in the municipality of Oliveira de Azeméis. There will be an experimental group that will undergo structured rehabilitation nursing consultations, and a control group that will receive the usual nursing care appropriate for asthma management.
Both groups will be subject to two evaluation moments with the CARAT test and the AQLQ-M questionnaire. Results The aim is to evaluate the effectiveness of interventions for people with asthma implemented within the framework of a structured rehabilitation nursing consultation. The investigators expected to observe a clinically significant improvement with regard to disease control, quality of life, and user empowerment.
Detailed description
By carrying out this study, the following aims are intended to be achieved:
Main Goal To evaluate the effectiveness of rehabilitation nursing interventions in adults with asthma in controlling symptoms and quality of life. Specific Goals To evaluate the symptomatic improvement, comparing the initial and final evaluation.
To evaluate the quality of life related to health, comparing the initial and final evaluation after consultations, using the Asthma Quality Of Life Questionnaire by Marks (AQLQ-M); To achieve the proposed objectives, the investigators started with the following question: What are the effects of a structured rehabilitation nursing consultation on asthma control and healthrelated quality of life? To answer this question, a randomized and controlled clinical trial will be carried out, with the intention of studying the effectiveness of the interventions under study, comparing them with usual care. The population under study are people with asthma, the sample being made up of adults with asthma, enrolled in the ACeS Entre Douro e Vouga II, belonging to the municipality of Oliveira de Azeméis. The sample will be consecutive non-random.
Participants will be randomly assigned to one of 2 groups, intervention or control. The encryption key will be prepared using MS Excel and will be filed in a closed cabinet under the responsibility of the principal investigator. The minimum necessary sample size was calculated considering the final comparison between the two groups. Therefore, stipulating the T test for independent samples as the procedure to be used, or the corresponding non-parametric Mann-Whitney U test, a significance level of 5%, a test power (1-β) of 80%, an effect magnitude high, the sample size to be collected will be 102 participants, which corresponds to 51 participants per group. Considering that the investigators may have 20% of follow-up losses, the sample size to be collected will be 102 participants (51 per group). Participants in both groups will be subject to two evaluation moments, an initial one during the first contact and another at the end of the intervention.
The following variables will be studied:
Independent variable Structured rehabilitation nursing consultation for people with asthma.
Main dependent variable:
- Asthma control - assessed with the Asthma and Allergic Rhinitis Control Test (CARAT) Secondary dependent variables
- Quality of life - assessed with the Asthma-Related Quality of Life Questionnaire (AQLQ - M)
- User empowerment - assessed with mPEI modified Patient Enablement Instrument. Intervention Both groups will have access to the health care recommended in the Integrated Care
Process for Asthma in Children and Adults, of the DGS, namely:
- Education for health;
- Inhalation technique;
- Adherence to treatment;
- Presence of comorbidities;
- Smoking;
- Other environmental factors;
- Promotion of physical activity. The rehabilitation nursing consultation will be carried out by the specialist nurse in rehabilitation nursing, at UCC Aveiro Norte, during the year 2023 and will be based on autonomous interventions in the domain of the specialist nurse in rehabilitation nursing, within the scope of training for self-management of asthma, breathing exercises. These interventions are in addition to those implemented in a Nursing consultation, for the person with asthma defined by the DGS and which will be applied in the control group, first consultation and in the fourth week. The Intervention group will be held during four consultations, one per week, where the following interventions will be carried out:
- Breathing awareness and control;
- Postural correction techniques;
- Relaxation techniques and resting positions;
- Airway permeabilization techniques
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdomino-diaphragmatic breathing | Experimental | Other: Abdomino-diaphragmatic breathing, Behavioral: Usual CareThere are four consultations with autonomous rehabilitation nursing intervention: abdomino-diaphragmatic breathing. In addition to adding the health care that is recommended in the Integrated Care Process for Asthma in Children and Adults, of the Portuguese Directorate-General for Health, namely: Health education: Inhalation technique Adherence to treatment; Presence of comorbidities; Smoking; Other environmental factors; Promotion of physical activity. |
| Usual care | Placebo comparator | Behavioral: Usual CareThey will have the care recommended in the Integrated Care Process for Asthma in Children and Adults, of the Portuguese Directorate-General for Health, namely: Health education: Inhalation technique Adherence to treatment; Presence of comorbidities; Smoking; Other environmental factors; Promotion of physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of asthma, with R96 coding according to ICPC2;
- Users enrolled in health units in the municipality of Oliveira de Azeméis.
Key exclusion criteria (3 listed)
- Impossibility of contacting the user to schedule the appointment;
- Users with severe cognitive dysfunction or psychiatric illness with interference in memory and adherence;
- Pregnant women
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 |
|---|---|---|
| Abdomino-diaphragmatic breathingBreathing should be done twice a day for 10 minutes. | Other | Abdomino-diaphragmatic breathing |
| Usual CareHealth education Review of inhaler technique Check adherence to treatment; Presence of comorbidities; Smoking; Other environmental factors; Promotion of physical activity | Behavioural | Abdomino-diaphragmatic breathing, Usual care |
Primary outcome
Symptom Control using the scale Allergic Rhinitis and Control of Asthma Test CARAT
Time frame: At the first and last consultation in 4 weeks
The CARAT questionnaire is composed of 10 questions that address upper and lower airway symptoms, sleep interference, activity limitation, and the need to increase medication over a four-week period. Scores above 24 indicate good disease control. Upper airway score (item 1-4): 0 Controlled if score >8 Lower airway score (item 5-10): 0 Controlled if score ≥16
Quality of life in asthma patients using the scale Mini Ashma Quality of Life Questionnaire (Mini- AQLQ)
Time frame: At the first and last consultation in 4 weeks
This instrument has 15 questions in the same domains as the original AQLQ (symptoms, activities, emotions and environment) and takes 3-4 minutes to complete. An increase of 0.5 in the Mini-AQLQ score is considered a clinically significant improvement.
Measure patient enablement in asthma using the scale mPEI
Time frame: At the last consultation, an average of 4 weeks after the first consultation
The mPEI is a six-item questionnaire. Each item is scored in a Likert-type scale from 0 ('same or less' or 'not applicable') to 2 ('much better'). There is a minimum score of 0 and a maximum score of 12. A higher score reflects higher patient enablement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Andreia Santos principal investigator
ACES Entre Douro e Vouga II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdomino-diaphragmatic breathing in people with Asthma and Rehabilitation, run by ACES Entre Douro e Vouga II - Aveiro Norte at 1 site in Portugal.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 30 Aug 2024. 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 Portugal. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Control using the scale Allergic Rhinitis and Control of Asthma Test CARAT (time frame: At the first and last consultation in 4 weeks). The study lists 3 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 30 Aug 2024.