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

Primary Purpose

Asthma, Rehabilitation, Breathing, Mouth

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Abdomino-diaphragmatic breathing
Usual Care
Sponsored by
ACES Entre Douro e Vouga II - Aveiro Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Nurse, Rehabilitation, Quality of life, Breathing exercises, Clinical Trials, Obstructive airway disease, Non-pharmacological therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ACES Entre Douro e Vouga II- Aveiro NorteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Abdomino-diaphragmatic breathing

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
September 9, 2023
Last Updated
September 28, 2023
Sponsor
ACES Entre Douro e Vouga II - Aveiro Norte
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1. Study Identification

Unique Protocol Identification Number
NCT06061497
Brief Title
Effectiveness of the Rehabilitation Nursing Consultation for People With Asthma on Symptom Control and Quality of Life
Official Title
Effectiveness of a Rehabilitation Nursing Consultation for People With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ACES Entre Douro e Vouga II - Aveiro Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Rehabilitation, Breathing, Mouth, Nursing Caries, Adult
Keywords
Asthma, Nurse, Rehabilitation, Quality of life, Breathing exercises, Clinical Trials, Obstructive airway disease, Non-pharmacological therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abdomino-diaphragmatic breathing
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Abdomino-diaphragmatic breathing
Intervention Description
Breathing should be done twice a day for 10 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Health education Review of inhaler technique Check adherence to treatment; Presence of comorbidities; Smoking; Other environmental factors; Promotion of physical activity
Primary Outcome Measure Information:
Title
Symptom Control using the scale Allergic Rhinitis and Control of Asthma Test CARAT
Description
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.
Time Frame
At the first and last consultation in 4 weeks
Title
Quality of life in asthma patients using the scale Mini Ashma Quality of Life Questionnaire (Mini- AQLQ)
Description
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.
Time Frame
At the first and last consultation in 4 weeks
Title
Measure patient enablement in asthma using the scale mPEI
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of asthma, with R96 coding according to ICPC2; Users enrolled in health units in the municipality of Oliveira de Azeméis. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Santos
Phone
+351912474550
Ext
10731
Email
andreiaposantos5@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreia Santos
Organizational Affiliation
ACES Entre Douro e Vouga II
Official's Role
Principal Investigator
Facility Information:
Facility Name
ACES Entre Douro e Vouga II- Aveiro Norte
City
Oliveira De Azemeis
State/Province
Aveiro
ZIP/Postal Code
3720-287
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreia Patrícia de Oliveira Santos
Phone
+351912474550
Email
andreiaposantos5@gmail.com

12. IPD Sharing Statement

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

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