Psychological Characteristics of Patients With Severe Asthma

Asthma Clinical Trial

— CATAPLASTHMA  

Official title:

Psychological Characteristics of Patients With Severe Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05739708
• Other study ID #: 2022/727
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Lucie Laurent, PhD
• Phone: 0381669293
• Email: llaurent[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Like any chronic disease, asthma exposes individuals to stressful and threatening situations that require ongoing cognitive, emotional, behavioral and social adaptation. Approximately 5-10% of patients with asthma have a treatment-resistant disease, with frequent emergency room visits and hospitalizations. These patients are responsible for the majority of the overall asthma-related disease burden and also represent more than half of the total direct costs of asthma management. The scientific literature shows that personality traits, attachment type and psychological disorders will significantly influence disease coping strategies, disease experience, quality of life, adherence and therapeutic alliance. Although some data exist in asthma, there are currently no studies that have evaluated the overall psychological profile of asthma patients, and we have no data specifically on the population of severe asthmatics, who are the most difficult to manage. A better understanding of the overall psychological dimension of asthma patients will make it possible to offer therapeutic education programs that are more targeted according to the psychosocial skills of the patient and finally improve the overall management of the disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient aged = 18 years and followed in the Respiratory Department of the Besançon University Hospital for an asthmatic disease diagnosed for more than 12 months. Will be considered as severe patients, asthma patients with uncontrolled asthma despite high therapeutic pressure (GINA levels 4 and 5) and patients requiring to be controlled high doses of inhaled corticosteroids and long-acting beta-2-agonists (or anti-leukotriene/theophylline) in the past year or systemic corticosteroid therapy (>50% in the previous year) (ATS-ERS 2014 criteria).

• Patient able to understand the objectives of the research

• Patient who has signed a research consent form

• Patient affiliated to a French social security system or beneficiary of such a system

Exclusion Criteria:

• Patient with reading and comprehension difficulties that prevent them from completing the questionnaires

• Motor disability that prevents the patient from completing the questionnaires

• Legal incapacity or limited legal capacity

• Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the the investigator

• Subject without health insurance

• Subject under court protection, guardianship, conservatorship, or protective supervision. protection.

Related Conditions & MeSH terms

• Asthma
• Attachment
• Coping Skills

Intervention

Other:
• Questionnaires
The time to complete the different questionnaires is estimated to be 60 minutes.

Locations

Country	Name	City	State
France	CHU de Besançon - Service de Pneumologie	Besançon	Doubs

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the psychological profile of severe asthma patients	Score on questionnaires assessing coping strategies (ACL-F)	1 day
Primary	Description of the psychological profile of severe asthma patients	Score on questionnaire personality traits (BFI-Fr)	1 day
Primary	Description of the psychological profile of severe asthma patients	Score on questionnaire attachment types (RSQ)	1 day
Primary	Description of the psychological profile of severe asthma patients	Score on questionnaire anxiety and depression (HADS)	1 day
Primary	Description of the psychological profile of severe asthma patients	Score on questionnaire quality of life (AQLQ)	1 day
Primary	Description of the psychological profile of severe asthma patients	Score on questionnaire patient-physician therapeutic alliance (WAI-SR)	1 day
Primary	Description of the psychological profile of severe asthma patients	Score on questionnaire 0Asthma Control Test (ACT)	1 day