Effectiveness of the Rehabilitation Nursing Consultation for People With Asthma on Symptom Control and Quality of Life

NCT06061497 | Completed

• 1 other identifier: RehabAsthma
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  At the last consultation, an average of 4 weeks after the first consultation

Study Arms (2)

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.

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.

Behavioral: Usual Care

Interventions

Abdomino-diaphragmatic breathing OTHER

Breathing should be done twice a day for 10 minutes.

Abdomino-diaphragmatic breathing

Usual Care BEHAVIORAL

Health education Review of inhaler technique Check adherence to treatment; Presence of comorbidities; Smoking; Other environmental factors; Promotion of physical activity

Abdomino-diaphragmatic breathing; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of asthma, with R96 coding according to ICPC2;
• Users enrolled in health units in the municipality of Oliveira de Azeméis.

You may not qualify if:

• 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

Sponsors & Collaborators

• ACES Entre Douro e Vouga II - Aveiro Norte: lead

Study Sites (1)

ACES Entre Douro e Vouga II- Aveiro Norte

Oliveira de Azeméis, Aveiro District, 3720-287, Portugal

Location

MeSH Terms

Conditions

Asthma; Mouth Breathing; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreia Santos

  ACES Entre Douro e Vouga II

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: September 9, 2023
• First Posted: September 29, 2023
• Study Start: July 3, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)