Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06061497 |
| Other study ID # |
RehabAsthma |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 3, 2023 |
| Est. completion date |
March 2024 |
Study information
| Verified date |
September 2023 |
| Source |
ACES Entre Douro e Vouga II - Aveiro Norte |
| Contact |
Santos |
| Phone |
+351912474550 |
| Email |
andreiaposantos5[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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 42 participants, which
corresponds to 21 participants per group. Considering that the investigators may have 20% of
follow-up losses, the sample size to be collected will be 50 participants (25 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
