Psychological Characteristics of Patients With Severe Asthma (NCT05739708) | Clinical Trial Compass
UnknownNot Applicable
Psychological Characteristics of Patients With Severe Asthma
France150 participantsStarted 2023-02-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Description of the psychological profile of severe asthma patients
Timeframe: 1 day
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Description of the psychological profile of severe asthma patients
Timeframe: 1 day
3
Description of the psychological profile of severe asthma patients
Timeframe: 1 day
4
Description of the psychological profile of severe asthma patients
Timeframe: 1 day
5
Description of the psychological profile of severe asthma patients
Timeframe: 1 day
6
Description of the psychological profile of severe asthma patients
Timeframe: 1 day
7
Description of the psychological profile of severe asthma patients
Timeframe: 1 day
Trial details
NCT IDNCT05739708
SponsorCentre Hospitalier Universitaire de Besancon