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Psychological Characteristics of Patients With Severe Asthma (CATAPLASTHMA)

Primary Purpose

Asthma, Attachment, Coping Skills

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Asthma patients

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2023
    Last Updated
    February 13, 2023
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05739708
    Brief Title
    Psychological Characteristics of Patients With Severe Asthma
    Acronym
    CATAPLASTHMA
    Official Title
    Psychological Characteristics of Patients With Severe Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2023 (Anticipated)
    Primary Completion Date
    February 15, 2024 (Anticipated)
    Study Completion Date
    February 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Attachment, Coping Skills, Personality Trait

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Asthma patients
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaires
    Other Intervention Name(s)
    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)
    Intervention Description
    The time to complete the different questionnaires is estimated to be 60 minutes.
    Primary Outcome Measure Information:
    Title
    Description of the psychological profile of severe asthma patients
    Description
    Score on questionnaires assessing coping strategies (ACL-F)
    Time Frame
    1 day
    Title
    Description of the psychological profile of severe asthma patients
    Description
    Score on questionnaire personality traits (BFI-Fr)
    Time Frame
    1 day
    Title
    Description of the psychological profile of severe asthma patients
    Description
    Score on questionnaire attachment types (RSQ)
    Time Frame
    1 day
    Title
    Description of the psychological profile of severe asthma patients
    Description
    Score on questionnaire anxiety and depression (HADS)
    Time Frame
    1 day
    Title
    Description of the psychological profile of severe asthma patients
    Description
    Score on questionnaire quality of life (AQLQ)
    Time Frame
    1 day
    Title
    Description of the psychological profile of severe asthma patients
    Description
    Score on questionnaire patient-physician therapeutic alliance (WAI-SR)
    Time Frame
    1 day
    Title
    Description of the psychological profile of severe asthma patients
    Description
    Score on questionnaire 0Asthma Control Test (ACT)
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Psychological Characteristics of Patients With Severe Asthma

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