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Role of "Asthma School" in Disease Management

Primary Purpose

Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
multidisciplinary lessons
Sponsored by
Istituti Clinici Scientifici Maugeri SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

•cognitive impairment

Sites / Locations

  • Istituti Clinici Maugeri PneumologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ASG= Asthma School Group, with educational intervention

CG= Control Group, With no educational intervention

Arm Description

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

Control group will attend control visits every three months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Asthma control test ACT (0-25)
evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).
Asthma control questionnaire ACQ (0-6)
evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).
St. George Respiratory questionnaire SGRQ (0-100)
assessing quality of life in Asthma School Group (ASG) compared to Control Group (CG).
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
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).

Full Information

First Posted
June 19, 2020
Last Updated
August 10, 2023
Sponsor
Istituti Clinici Scientifici Maugeri SpA
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1. Study Identification

Unique Protocol Identification Number
NCT04442646
Brief Title
Role of "Asthma School" in Disease Management
Official Title
Role of "Asthma School" in Disease Management
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituti Clinici Scientifici Maugeri SpA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASG= Asthma School Group, with educational intervention
Arm Type
Experimental
Arm Description
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
Arm Title
CG= Control Group, With no educational intervention
Arm Type
No Intervention
Arm Description
Control group will attend control visits every three months.
Intervention Type
Behavioral
Intervention Name(s)
multidisciplinary lessons
Intervention Description
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
Primary Outcome Measure Information:
Title
number of exacerbations
Description
number of exacerbations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.
Time Frame
2 years
Title
ER accesses
Description
ER accesses in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.
Time Frame
2 years
Title
number of asthma related hospitalizations
Description
number of asthma related hospitalizations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Asthma control test ACT (0-25)
Description
evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).
Time Frame
2 years
Title
Asthma control questionnaire ACQ (0-6)
Description
evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).
Time Frame
2 years
Title
St. George Respiratory questionnaire SGRQ (0-100)
Description
assessing quality of life in Asthma School Group (ASG) compared to Control Group (CG).
Time Frame
2 years
Title
airways and systemic inflammation
Description
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 years
Title
respiratory function
Description
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).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Asthma diagnosis according to GINA / ATS guidelines. Age ≥18 years Exclusion Criteria: •cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina Visca, Prof.
Phone
0331829599
Email
dina.visca@icsmaugeri.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Spanevello, Prof
Organizational Affiliation
ICS Maugeri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituti Clinici Maugeri Pneumologia
City
Tradate
State/Province
Lombardia
ZIP/Postal Code
21049
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina Visca
Phone
+390331829409
Email
dina.visca@icsmaugeri.it
First Name & Middle Initial & Last Name & Degree
Francesca Cherubino
Phone
+390331829599
Email
francesca.cherubino@icsmaugeri.it
First Name & Middle Initial & Last Name & Degree
Antonio Spanevello, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29060130
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.
Results Reference
background
PubMed Identifier
28408742
Citation
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.
Results Reference
background
PubMed Identifier
1865168
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.
Results Reference
background
PubMed Identifier
2311729
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.
Results Reference
background

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Role of "Asthma School" in Disease Management

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