Psychological Characteristics of Patients With Severe Asthma

NCT05739708 | Recruiting

• 1 other identifier: 2022/727
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

Asthma patients

OTHER

Other: Questionnaires

Interventions

Questionnaires OTHER

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

Also known as: 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)

Asthma patients

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon - Service de Pneumologie

Besançon, Doubs, 25000, France

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Lucie Laurent, PhD

CONTACT

0381669293; llaurent@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 22, 2023
• Study Start: February 15, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

FR (1)