Psychological Characteristics of Patients With Severe Asthma (CATAPLASTHMA)

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Coping Skills; Attachment; Personality Trait
• Intervention / Treatment: Other: Questionnaires

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucie Laurent, PhD; Phone Number: +33 0381669293; Email: llaurent@chu-besancon.fr

Study Locations

• France
  • Doubs
    • Besançon, Doubs, France, 25000
      • Recruiting
      • CHU de Besançon - Service de Pneumologie
      • Contact: Lucie Laurent, PhD; Phone Number: +33 0381669293; Email: llaurent@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Asthma patients

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): February 15, 2024
• Study Completion (Estimated): February 15, 2024

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2022/727

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No