An interventional study of Abdomino-diaphragmatic breathing and Usual Care in Asthma, Rehabilitation and Breathing, Mouth, sponsored by ACES Entre Douro e Vouga II - Aveiro Norte. Completed at 1 site in Portugal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-30.
Sponsored by ACES Entre Douro e Vouga II - Aveiro Norte · Not applicable, Interventional, and Treatment
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.
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:
Process for Asthma in Children and Adults, of the DGS, namely:
4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 102 is above the median of 83 across 2,814 interventional studies indexed under Asthma.
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Exclusion Criteria:
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.
Other: Abdomino-diaphragmatic breathing · Behavioral: Usual Care
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.
Behavioral: Usual Care
Breathing should be done twice a day for 10 minutes.
Health education Review of inhaler technique Check adherence to treatment; Presence of comorbidities; Smoking; Other environmental factors; Promotion of physical activity
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
Time frame: 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.
Time frame: 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
Time frame: At the last consultation, an average of 4 weeks after the first consultation
Plan to share: No
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