This study aims to determine the prevalence of Asthma, Difficult-to-Treat and Severe Asthma in Portugal, and characterize patients to better understand their disease characteristics, treatment profile and health care resource use to improve clinical management of the disease.
Data on the epidemiology of asthma in Portugal were mainly grounded in studies using questionnaires and covering limited age groups. Studies assessing the prevalence of asthma diagnosis and of its sub-groups with more accurate methods are therefore needed This study aims to determine the prevalence of asthma, difficult-to-treat and severe asthma in Portugal, and to characterize patients to better understand their disease characteristics, treatment profile and health care resource use to improve clinical management of the disease. We will conduct a population-based nationwide study with a multicentre stepwise approach, enrolling 7500 adult subjects, randomly selected, from the Portuguese National Health Service patients' database of 38 primary care centres: STAGE 0 - Phone call invitation and enrolment of participants STAGE 1 - Telephone interview survey to assess respiratory symptoms. STAGE 2 - Clinical assessment, diagnostic confirmation, and patient characterization STAGE 3 - Characterization of asthma patients (sub-group) and characterization of difficult- to-treat asthma \& severe asthma patients after 3 months follow up period.
Study Type
OBSERVATIONAL
Enrollment
842
Proportion of participants with asthma, difficult-to-treat asthma, and severe asthma
Ratio between the total number of participants with confirmed asthma, difficult-to-treat asthma, and severe asthma and the total number of participants
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Age
Years
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Living in a city or rural community
Postal code
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Family history
Family history of asthma and asthma death and type of relationship
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Comorbidities and allergies
List of comorbidities with major impact on asthma outcomes
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Obesity
WHO classification of body mass index
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Physical activity
Using the brief physical activity assessment questionnaire. This brief physical activity assessment has only two questions and subjects are scored on \< 4 (Insufficiently" active) and ⩾4 ("Sufficiently" active).
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Research Site
Alpendorada, Portugal, Portugal
Research Site
Vila Cova Da Lixa, Portugal, Portugal
Research Site
Aradas, Portugal
Research Site
Arazede, Portugal
Research Site
Braga, Portugal
Research Site
Cascais, Portugal
Research Site
Coimbra, Portugal
Research Site
Evora, Portugal
Research Site
Evora, Portugal
Research Site
Fafe, Portugal
...and 27 more locations
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Health related quality of life
Using mini AQLQ Questionnaire AQLQ is a multiple-choice questionnaire for patients with asthma, each choice is assigned a score 1-7. There are 15 questions to answer. The total score is calculated and ranges between 15 and 105. Lower scores indicate worse quality of life.
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Healthcare resource use and costs
a) Direct resources will include number of inpatient admissions, emergency and hospital visits, medical appointments, diagnostic tests previously performed for asthma treatment in the last 12 months. b) Indirect resources will include reduced productivity of Asthma patients through an ad-hoc questionnaire about absenteeism (work and school days lost because of asthma) and presenteeism (reduced productivity due to asthma) in the last 12 months.
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Referral
number of patients that should be referral for asthma specialist hospital Consultation or that were referred to Severe Asthma consultation
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Age of Asthma onset
Age of Asthma onset
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Asthma symptoms
According to Control of Allergic Rhinitis and Asthma Test (CARAT). CARAT is a 10-item validated Portuguese questionnaire, which allows for the simultaneous assessment of allergic rhinitis and asthma (ARA) control. A score above 24 (min. 0; max. 30) identifies controlled asthma.
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Pulmonary function tests
Spirometry and reversibility testing
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Inflammatory biomarkers
Fractional exhaled nitric oxide (FeNO) test and blood eosinophil and neutrophil count,
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Exacerbations
Number of exacerbations in the past year
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Emergency room (ER) visits
Number of visits to emergency room (ER) within the past year
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Hospital admissions
Number of hospital admissions and mean length of hospital stay in the past year
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Disease Characteristics - Disease control
According to Control of Allergic Rhinitis and Asthma Test (CARAT). CARAT is a 10-item validated Portuguese questionnaire, which allows for the simultaneous assessment of allergic rhinitis and asthma (ARA) control. A score above 24 (min. 0; max. 30) identifies controlled asthma.
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Treatment Patterns - Treatment profile (current and last year)
Stage of GINA treatment step according to GINA guidelines
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Treatment Patterns - Treatment adherence
Assessed using a Visual Analogue Scale (VAS) from 0 to 100, 0 means poor adherence and 100 good adherence
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Treatment Patterns - Inhalation technique
Assessed by the clinician using national checklists
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Gender
Male/Female
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Marital status
Single, Married / De facto Union, Separated / Divorced, Widowed
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - socio-economic and education level
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - occupational status
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Smoking status & environmental tobacco smoke
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)
Subject's characteristics - Health related quality of life
Using EQ-5D. EQ-5D is a questionnaire which include five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). and is used to evaluate the quality of life. Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).
Time frame: From date of inclusion until the end of the study currently planned (2,5 years)