Asthma
Conditions
Keywords
Asthma, Severe Asthma, Difficult-to-treat asthma, Prevalence
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Faculdade de Medicina da Universidade do Porto - CINTESIS
Universidade do Minho - ICVS
AstraZeneca
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults =\>18 years old registered in Portuguese National Health service patients' database of primary care units. * Give voluntary signed informed consent, * Ability to understand ans answer questionnaires.
Exclusion criteria
* Participants that have a physical condition that could interfere with the study assessments or prevent the participant from adequately participating in the study (e.g. mobility problems, not able to perform spirometry,…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with asthma, difficult-to-treat asthma, and severe asthma | From date of inclusion until the end of the study currently planned (2,5 years) | Ratio between the total number of participants with confirmed asthma, difficult-to-treat asthma, and severe asthma and the total number of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's characteristics - Age | From date of inclusion until the end of the study currently planned (2,5 years) | Years |
| Subject's characteristics - Living in a city or rural community | From date of inclusion until the end of the study currently planned (2,5 years) | Postal code |
| Subject's characteristics - Family history | From date of inclusion until the end of the study currently planned (2,5 years) | Family history of asthma and asthma death and type of relationship |
| Subject's characteristics - Comorbidities and allergies | From date of inclusion until the end of the study currently planned (2,5 years) | List of comorbidities with major impact on asthma outcomes |
| Subject's characteristics - Obesity | From date of inclusion until the end of the study currently planned (2,5 years) | WHO classification of body mass index |
| Subject's characteristics - Physical activity | From date of inclusion until the end of the study currently planned (2,5 years) | 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). |
| Subject's characteristics - Health related quality of life | From date of inclusion until the end of the study currently planned (2,5 years) | 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. |
| Subject's characteristics - Healthcare resource use and costs | From date of inclusion until the end of the study currently planned (2,5 years) | 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. |
| Subject's characteristics - Referral | From date of inclusion until the end of the study currently planned (2,5 years) | number of patients that should be referral for asthma specialist hospital Consultation or that were referred to Severe Asthma consultation |
| Disease Characteristics - Age of Asthma onset | From date of inclusion until the end of the study currently planned (2,5 years) | Age of Asthma onset |
| Disease Characteristics - Asthma symptoms | From date of inclusion until the end of the study currently planned (2,5 years) | 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. |
| Disease Characteristics - Pulmonary function tests | From date of inclusion until the end of the study currently planned (2,5 years) | Spirometry and reversibility testing |
| Disease Characteristics - Emergency room (ER) visits | From date of inclusion until the end of the study currently planned (2,5 years) | Number of visits to emergency room (ER) within the past year |
| Disease Characteristics - Exacerbations | From date of inclusion until the end of the study currently planned (2,5 years) | Number of exacerbations in the past year |
| Disease Characteristics - Hospital admissions | From date of inclusion until the end of the study currently planned (2,5 years) | Number of hospital admissions and mean length of hospital stay in the past year |
| Disease Characteristics - Disease control | From date of inclusion until the end of the study currently planned (2,5 years) | 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. |
| Treatment Patterns - Treatment profile (current and last year) | From date of inclusion until the end of the study currently planned (2,5 years) | Stage of GINA treatment step according to GINA guidelines |
| Treatment Patterns - Treatment adherence | From date of inclusion until the end of the study currently planned (2,5 years) | Assessed using a Visual Analogue Scale (VAS) from 0 to 100, 0 means poor adherence and 100 good adherence |
| Treatment Patterns - Inhalation technique | From date of inclusion until the end of the study currently planned (2,5 years) | Assessed by the clinician using national checklists |
| Subject's characteristics - Gender | From date of inclusion until the end of the study currently planned (2,5 years) | Male/Female |
| Subject's characteristics - Marital status | From date of inclusion until the end of the study currently planned (2,5 years) | Single, Married / De facto Union, Separated / Divorced, Widowed |
| Subject's characteristics - socio-economic and education level | From date of inclusion until the end of the study currently planned (2,5 years) | — |
| Subject's characteristics - occupational status | From date of inclusion until the end of the study currently planned (2,5 years) | — |
| Subject's characteristics - Smoking status & environmental tobacco smoke | From date of inclusion until the end of the study currently planned (2,5 years) | — |
| Disease Characteristics - Inflammatory biomarkers | From date of inclusion until the end of the study currently planned (2,5 years) | Fractional exhaled nitric oxide (FeNO) test and blood eosinophil and neutrophil count, |
Countries
Portugal
Outcome results
None listed