Role of "Asthma School" in Disease Management
ConditionAsthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
According to the definition provided by the GINA guidelines, asthma is characterized by a variable and reversible limitation of expiratory airflow and by the following symptoms: wheezing, dyspnoea, thoracic constriction and/or cough. The type and the severity of airflow limitation can vary over time (1) depending on external agents, such as physical exercise, polluting agents, climate changes and viral infections. The therapy is mainly based on the use of inhaled corticosteroids and bronchodilators. Patients affected by severe asthma (\~ 10% of total prevalence of asthma and at high risk of exacerbations and/or hospitalization) may not control their symptoms, even if exposed to maximal doses of inhalation therapy.The behavioural sciences can potentially help to find the psychological factors behind scarce adherence and to develop strategies with the aim of improving the interactive processes between patients, medical doctors and health care professionals
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Asthma diagnosis according to GINA / ATS guidelines.
Age ≥18 years
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
multidisciplinary lessons
Behavioralthe multidisciplinary lessons will be conducted by study staff, formed by pneumologist, nurse, biologist and respiratory therapist once a week within 1 month after randomization. Study staff will deal with the following topics: asthma physiopathology, recognition of asthma symptoms and exacerbation, educational interventions on therapy and device, nutritional counselling if necessary. Patients will receive a paper diary for symptoms and an expiratory pick flow meter (PFM) to be done twice a day
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: ASG= Asthma School Group, with educational interventionExperimental treatment 1 intervention
Group B: CG= Control Group, With no educational interventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
number of exacerbations
number of exacerbations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.
Time frame
2 years2
ER accesses
ER accesses in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.
Time frame
2 years3
number of asthma related hospitalizations
number of asthma related hospitalizations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.
Time frame
2 yearsSecondary outcomes
1
Asthma control test ACT (0-25)
evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).
Time frame
2 years2
Asthma control questionnaire ACQ (0-6)
evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).
Time frame
2 years3
St. George Respiratory questionnaire SGRQ (0-100)
assessing quality of life in Asthma School Group (ASG) compared to Control Group (CG).
Time frame
2 years4
airways and systemic inflammation
differential cell count in sputum and blood in Asthma School Group (ASG) compared to Control Group (CG). Sputum inflammatio: number eosinophills \>3%, sistemic inflammation: eosiniphils cell count \>250 cell/ul
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov