Effectiveness of a Rehabilitation Nursing Consultation for People With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Symptom Control using the scale Allergic Rhinitis and Control of Asthma Test CARAT
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of asthma, with R96 coding according to ICPC2;
- •Users enrolled in health units in the municipality of Oliveira de Azeméis.
排除标准
- •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
研究组 & 干预措施
Abdomino-diaphragmatic breathing
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.
干预措施: Abdomino-diaphragmatic breathing (Other)
Abdomino-diaphragmatic breathing
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.
干预措施: Usual Care (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.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Symptom Control using the scale Allergic Rhinitis and Control of Asthma Test CARAT
时间窗: 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)
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Andreia Patrícia de Oliveira Santos
Investigator
ACES Entre Douro e Vouga II - Aveiro Norte