Psychological Characteristics of Patients With Severe Asthma

NCT ID: NCT05739708

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2024-02-15

Brief 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.

Conditions

Asthma; Attachment; Coping Skills; Personality Trait

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Asthma patients

Group Type: OTHER

Questionnaires

Intervention Type: OTHER

The time to complete the different questionnaires is estimated to be 60 minutes.

Interventions

Questionnaires

The time to complete the different questionnaires is estimated to be 60 minutes.

Intervention Type: OTHER

Other Intervention Names

Asthma Coping List (French version); Big Five Inventory (French version); Relationship Scales Questionnaire (French version); Hospital Anxiety and Depression Scale (French version); Asthma Quality of Life Questionnaire (French version); Working Alliance Inventory-Short Form Revised (French version); Asthma Control Test (French version); Morisky Medication Adherence Scale (French version)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Besançon - Service de Pneumologie

Besançon, Doubs, France

Site Status: RECRUITING

Countries

France

Central Contacts

Lucie Laurent, PhD

Role: CONTACT

llaurent@chu-besancon.fr

0381669293 ext. +33

Facility Contacts

Lucie Laurent, PhD

Role: primary

llaurent@chu-besancon.fr

0381669293 ext. +33

Other Identifiers

2022/727

Identifier Type: -

Identifier Source: org_study_id