Role of "Asthma School" in Disease Management

Asthma Clinical Trial

Official title:

Role of "Asthma School" in Disease Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04442646
• Other study ID #: 2278CE
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: Dina Visca, Prof.
• Phone: 0331829599
• Email: dina.visca[@]icsmaugeri.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Asthma is a chronic inflammatory disease affecting 300 million people worldwide, especially children. In Italy, asthma affects 3 million patients and represents one of the main expenses of the Italian National Heath Care Service. 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. More than one third of severe asthma patients receive oral corticosteroids prescriptions, with the risk of severe and irreversible adverse events. Therapy adherence is generally poor when therapeutic regimes are prescribed for chronic diseases, including asthma (4). 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 (4). Several studies have described intervention models focused on education of the patients to symptoms and exacerbations recognition, therapy management, reduction of the exposure to trigger agents and improvement of social and physical activities (5-6). The intervention is not able to make patients independent in disease managing, but can improve the cooperation in asthma management. Another important aspect in asthma management is the quality of the therapeutic intervention: the correct delivery of inhalation therapy is the key for the disease control (3). Specific educational intervention such as "asthma school" can improve symptoms control and reduce; however, up to day, a universal and standardized protocol is not available and further studies are needed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: September 1, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Asthma diagnosis according to GINA / ATS guidelines.

• Age =18 years

Exclusion Criteria:

•cognitive impairment

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• multidisciplinary lessons
the 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

Locations

Country	Name	City	State
Italy	Istituti Clinici Maugeri Pneumologia	Tradate	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Klijn SL, Hiligsmann M, Evers SMAA, Roman-Rodriguez M, van der Molen T, van Boven JFM. Effectiveness and success factors of educational inhaler technique interventions in asthma & COPD patients: a systematic review. NPJ Prim Care Respir Med. 2017 Apr 13;27(1):24. doi: 10.1038/s41533-017-0022-1. — View Citation

Muhlhauser I, Richter B, Kraut D, Weske G, Worth H, Berger M. Evaluation of a structured treatment and teaching programme on asthma. J Intern Med. 1991 Aug;230(2):157-64. doi: 10.1111/j.1365-2796.1991.tb00424.x. — View Citation

Nair AS, DeMuth K, Chih-Wen Cheng, Wang MD. Asthma Academy: Developing educational technology to improve Asthma medication adherence and intervention efficiency. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:1364-1367. doi: 10.1109/EMBC.2017.8037086. — View Citation

Ringsberg KC, Wiklund I, Wilhelmsen L. Education of adult patients at an "asthma school": effects on quality of life, knowledge and need for nursing. Eur Respir J. 1990 Jan;3(1):33-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of exacerbations	number of exacerbations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.	2 years
Primary	ER accesses	ER accesses in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.	2 years
Primary	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.	2 years
Secondary	Asthma control test ACT (0-25)	evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).	2 years
Secondary	Asthma control questionnaire ACQ (0-6)	evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).	2 years
Secondary	St. George Respiratory questionnaire SGRQ (0-100)	assessing quality of life in Asthma School Group (ASG) compared to Control Group (CG).	2 years
Secondary	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	2 years
Secondary	respiratory function	Forced Expiratory Volume in 1 second (FEV1) l, %, Forced Volume Capacity (FVC) l,%, FEV1 / FVC% values in Asthma School Group (ASG) compared to Control Group (CG).	2 years