HU Virgen de la Victoria
Málaga, Malaga, 29010, Spain
NCT Number: NCT06811155
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.
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Notify Me18 year and older
All sexes
Observational
Málaga, Malaga, 29010, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: Data collected for 6 months
To describe the sociodemographic and clinical characteristics of the study population
Time frame: Data collected for 6 months
To describe the treatment patterns (maintenance treatment, reliever treatment, type of treatment)
Time frame: Data collected for 6 months
To describe the disease control level in the study population
Time frame: Data collected for 6 months
To describe the use of health resources (emergency visit, Primary care visits, specialist visits)
Time frame: Data collected for 6 months
To describe the number of patients with SABA discontinuation
Hospital Universitario Virgen de la Victoria
Other
Non-Interventional, Descriptive, Cross-sectional and Unicentric Study to Describe the Clinical Management in Asthmatic Patients Attended in the Influential Area of Hospital Universitario Virgen de la Victoria, Málaga
Acronym: (NICMA)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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