Role of "Asthma School" in Disease Management

NCT04442646 | Recruiting

• 1 other identifier: 2278CE
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• number of exacerbations

  number of exacerbations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.

  2 years

• ER accesses

  ER accesses in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.

  2 years

• 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 Outcomes (5)

• Asthma control test ACT (0-25)

  2 years

• Asthma control questionnaire ACQ (0-6)

  2 years

• St. George Respiratory questionnaire SGRQ (0-100)

  2 years

• airways and systemic inflammation

  2 years

• respiratory function

  2 years

Study Arms (2)

ASG= Asthma School Group, with educational intervention

EXPERIMENTAL

experimental "asthma school" group (ASG) will attend control visits as Control Group every three months. In addiction, ASG will attend 3 further meetings consisting in multidisciplinary lessons (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

Behavioral: multidisciplinary lessons

CG= Control Group, With no educational intervention

NO INTERVENTION

Control group will attend control visits every three months.

Interventions

multidisciplinary lessons BEHAVIORAL

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

ASG= Asthma School Group, with educational intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asthma diagnosis according to GINA / ATS guidelines.
• Age ≥18 years

You may not qualify if:

• cognitive impairment

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Maugeri Pneumologia

Tradate, Lombardy, 21049, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 29060130 BACKGROUND

• 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.

  PMID: 28408742 BACKGROUND

• 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.

  PMID: 1865168 BACKGROUND

• 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.

  PMID: 2311729 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Antonio Spanevello, Prof

  ICS Maugeri

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina Visca, Prof.

CONTACT

0331829599; dina.visca@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 22, 2020
• Study Start: April 1, 2019
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)