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CATAPLASTHMA: Psychological Characteristics of Patients With Severe Asthma

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05739708
Collaborator
(none)
150
Enrollment
1
Arm
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaires
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Psychological Characteristics of Patients With Severe Asthma
Anticipated Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Feb 15, 2024
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Description of the psychological profile of severe asthma patients [1 day]

      Score on questionnaires assessing coping strategies (ACL-F)

    2. Description of the psychological profile of severe asthma patients [1 day]

      Score on questionnaire personality traits (BFI-Fr)

    3. Description of the psychological profile of severe asthma patients [1 day]

      Score on questionnaire attachment types (RSQ)

    4. Description of the psychological profile of severe asthma patients [1 day]

      Score on questionnaire anxiety and depression (HADS)

    5. Description of the psychological profile of severe asthma patients [1 day]

      Score on questionnaire quality of life (AQLQ)

    6. Description of the psychological profile of severe asthma patients [1 day]

      Score on questionnaire patient-physician therapeutic alliance (WAI-SR)

    7. Description of the psychological profile of severe asthma patients [1 day]

      Score on questionnaire 0Asthma Control Test (ACT)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT05739708
    Other Study ID Numbers:
    • 2022/727
    First Posted:
    Feb 22, 2023
    Last Update Posted:
    Feb 22, 2023
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Feb 22, 2023