Asthma
Conditions
Keywords
asthma, clinical management, exacerbations
Brief summary
Asthma is a heterogenic chronic disease that affects more than 300 million people worldwide, which it's characterized by acute symptomatic episodes of varying severity, including intermittently inflammation and narrowing of the airways in the lungs. The prevalence in Spain it is estimated to be around 5%, according to the European Community Respiratory Survey (ECRHS) and seems to be increased due to a higher rate of asthma diagnosis. In this condition there's substantial proportion of patients with a poor disease control, which conducts to an important negative impact in their health-related quality of life (HRQoL) and the need to use health care resources. During the past decades multiple clinical practice guidelines, such as the international Global Initiative for Asthma (GINA) and national guidelines as Guía Española para el Manejo del Asma (GEMA) have been launched with the aim of improving quality of care in patients with asthma and reduce the high public burden associated to this disease. However, several studies have concluded that high proportion of patients remain uncontrolled, being in Spain estimated around 50%, and there's direct evidence of poor adherence to the guideline's recommendations for asthma management. This evidence raises the need to determine the assistance quality care in asthma population in the influential area of Hospital Universitario Virgen de la Victoria through the assistance quality care indicators established by GEMA guidelines. The aim of this study is to obtain clinical data that allow to assess assistance quality degree in order to find improvement opportunities to achieve a better control of asthmatic patients within this influential area.
Detailed description
A non-Interventional, descriptive, cross-sectional and unicentric study, has been designed and will be conducted in a Spanish hospital of Málaga. The design of the study imposes an only visit to be performed to obtain the patient's signed IC and after signing it (if patient agreed to participate in the study. Except for this study visit, the rest of study will be based on electronic medical chart review of approximately 300 asthma patients belonging the influential area of Hospital Universitario Virgen de la Victoria. This chart review will be performed by the site investigator or collaborators. The data collection is stated in 6 months, and during this period the investigators will identify and randomly include the patients who meet selection criteria to avoid bias during patient's inclusion. The observational period will be conformed of 12 months, and the patient's data will be collected or documented in an electronic case report form (eCRF), which will automatically create or assign an identification numerical code to every patient the moment it's created in the electronic platform. This system guarantees the anonymization of each patient included in the study as no identifiable information won't be able to be captured.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
1. Patient with written informed consent prior to participation. 2. Patient female or male ≥ 18 years of age 3. Patient with asthma diagnosis more than one year before the study inclusion 4. Clinical data available at least 1 year before the study inclusion in the electronic medical records.
Exclusion criteria
1\. Patient's participation in any clinical trial during the year prior to the index date for data collection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Management in Asthmatic Patients | Data collected for 6 months | Describe the clinical management in asthmatic patients in the influential area of Hospital Universitario Virgen de la Victoria according to the assistance quality indicators established by GEMA guidelines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sociodemographic and Clinical Characteristics | Data collected for 6 months | To describe the sociodemographic and clinical characteristics of the study population |
| Treatment Patterns. | Data collected for 6 months | To describe the treatment patterns (maintenance treatment, reliever treatment, type of treatment) |
| Level of Disease Control | Data collected for 6 months | To describe the disease control level in the study population |
| Use of Health Resources | Data collected for 6 months | To describe the use of health resources (emergency visit, Primary care visits, specialist visits) |
| Number of Patients With SABA Discontinuation | Data collected for 6 months | To describe the number of patients with SABA discontinuation |
Countries
Spain
Participant flow
Pre-assignment details
A total of 305 patients were screened for being included in the study. Of them, 17 patients did not meet all the eligibility criteria, with a final sample size of 288 patients
Participants by arm
| Arm | Count |
|---|---|
| Asthma Patients A total of 305 patients were screened for being included in the study. Of them, 17 patients did not meet all the eligibility criteria, with a final sample size of 288 patients | 288 |
| Total | 288 |
Baseline characteristics
| Characteristic | Asthma Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 52 Participants |
| Age, Categorical Between 18 and 65 years | 236 Participants |
| Age, Continuous | 48 YEARS STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants |
| Race (NIH/OMB) White | 272 Participants |
| Region of Enrollment Spain | 288 participants |
| Sex: Female, Male Female | 185 Participants |
| Sex: Female, Male Male | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 288 |
| other Total, other adverse events | 0 / 288 |
| serious Total, serious adverse events | 0 / 288 |
Outcome results
Clinical Management in Asthmatic Patients
Describe the clinical management in asthmatic patients in the influential area of Hospital Universitario Virgen de la Victoria according to the assistance quality indicators established by GEMA guidelines
Time frame: Data collected for 6 months
Population: The level of compliance was evaluated in the total study population (n=288) for row number 1, 4 and 6.~For row number 2, we evaluated those patients included in the study with a history of allergic asthma (n=122).~For row number 3, we evaluated the patients who were smokers at study entry (n=38).~For row number 5, we evaluated patients with mild, moderate or severe persistent asthma (n=91).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Asthma Patients | Clinical Management in Asthmatic Patients | Asthma diagnosis confirmed by spirometry and bronchodilator test | 60 Participants |
| Asthma Patients | Clinical Management in Asthmatic Patients | Sensitization to allergen study in patients with history of suspected allergic asthma | 64 Participants |
| Asthma Patients | Clinical Management in Asthmatic Patients | Smoker patients who were advised on the importance of stopping this habit | 29 Participants |
| Asthma Patients | Clinical Management in Asthmatic Patients | Patients who were included in an educational plan | 41 Participants |
| Asthma Patients | Clinical Management in Asthmatic Patients | Patient who were receiving inhaled glucocorticoids at inclusion date for persistent asthma treatment | 84 Participants |
| Asthma Patients | Clinical Management in Asthmatic Patients | Patients who had an evaluation and documentation of exacerbations | 40 Participants |
Level of Disease Control
To describe the disease control level in the study population
Time frame: Data collected for 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Asthma Patients | Level of Disease Control | ACT score ≥20 (well-controlled asthma) | 158 Participants |
| Asthma Patients | Level of Disease Control | ACT score <20 (uncontrolled asthma) | 130 Participants |
Number of Patients With SABA Discontinuation
To describe the number of patients with SABA discontinuation
Time frame: Data collected for 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asthma Patients | Number of Patients With SABA Discontinuation | 28 Participants |
Sociodemographic and Clinical Characteristics
To describe the sociodemographic and clinical characteristics of the study population
Time frame: Data collected for 6 months
Population: We have only described the most prevalent demographic and clinical characteristic from the patients in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Asthma Patients | Sociodemographic and Clinical Characteristics | White ethnicity | 272 Participants |
| Asthma Patients | Sociodemographic and Clinical Characteristics | Positive pregnancy status | 3 Participants |
| Asthma Patients | Sociodemographic and Clinical Characteristics | Female gender | 185 Participants |
| Asthma Patients | Sociodemographic and Clinical Characteristics | Chronic pulmonary disease comorbidity | 56 Participants |
| Asthma Patients | Sociodemographic and Clinical Characteristics | Patient's management in primary care | 269 Participants |
| Asthma Patients | Sociodemographic and Clinical Characteristics | Mild intermittent asthma severity degree according to GEMA guidelines | 197 Participants |
| Asthma Patients | Sociodemographic and Clinical Characteristics | Step 1 asthma therapeutic level according to GEMA stepwise therapy | 178 Participants |
Treatment Patterns.
To describe the treatment patterns (maintenance treatment, reliever treatment, type of treatment)
Time frame: Data collected for 6 months
Population: We have described the treatments patterns from all the patients in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Asthma Patients | Treatment Patterns. | Short-acting β2 agonist (SABA) | 76 Participants |
| Asthma Patients | Treatment Patterns. | long-acting muscarinic antagonist (LAMA) | 14 Participants |
| Asthma Patients | Treatment Patterns. | Inhaled glucocorticoid (GCI) | 153 Participants |
| Asthma Patients | Treatment Patterns. | leukotriene receptor antagonist (LTRA) | 25 Participants |
| Asthma Patients | Treatment Patterns. | Long-acting β agonist (LABA) + Inhaled glucocorticoid (GCI) | 139 Participants |
| Asthma Patients | Treatment Patterns. | Biologic | 6 Participants |
| Asthma Patients | Treatment Patterns. | Inmunomodulator | 5 Participants |
| Asthma Patients | Treatment Patterns. | Oral corticosteroids (OCS) | 35 Participants |
| Asthma Patients | Treatment Patterns. | Other | 12 Participants |
Use of Health Resources
To describe the use of health resources (emergency visit, Primary care visits, specialist visits)
Time frame: Data collected for 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Asthma Patients | Use of Health Resources | Mean number of emergencies visits due to asthma | 0.07 Visits | Standard Deviation 0.32 |
| Asthma Patients | Use of Health Resources | Mean number of unscheduled primary care visits due to asthma | 0.13 Visits | Standard Deviation 0.39 |
| Asthma Patients | Use of Health Resources | Mean number of scheduled primary care visits | 0.12 Visits | Standard Deviation 0.55 |
| Asthma Patients | Use of Health Resources | Mean number of unexpected primary care visits | 0.13 Visits | Standard Deviation 0.39 |
| Asthma Patients | Use of Health Resources | Mean number of allergology visits | 0.19 Visits | Standard Deviation 0.77 |
| Asthma Patients | Use of Health Resources | Mean number of pneumology visits | 0.12 Visits | Standard Deviation 0.42 |