Educational Needs of Patients With Severe Asthma on Targeted Immunotherapies
ConditionSevere Asthma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers
About this trial
Severe asthma is a debilitating disease that affects every aspect of patients' lives: daily life, work, social life, family life, and marital life. The advent of biologic therapies has transformed these patients' quality of life by improving asthma control, access to care, and overall quality of life. But how do patients actually experience this transformation in their lives? What has actually changed for them, based on their own perceptions? Investigator hypothesize that a hypothetical-deductive qualitative study with a methodology focused on each patient's individual situation will allow to better explore the changes that have occurred in these patients' lives.
The BASIC Study aims to understand, through semi-structured interviews, how the lives of patients on biologic therapy have evolved. Patient therapeutic education is an integral part of the care provided to patients with severe asthma in the Pulmonology Department at Angers University Hospital. This therapeutic education is truly centered on patients' needs thanks to a methodology designed to reveal units of meaning. The BASIC study will employ the same methodology to analyze patients' life situations in order to better understand the changes they perceive while on biologic therapy, as well as their new educational needs. The results would make it possible to assess the qualitative effectiveness of biologic therapies from a unique patient-centered perspective, as well as to identify new educational needs among these patients. Thus, the current therapeutic education program could be enhanced.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients.
Patients with severe asthma who have been receiving targeted therapy (with omalizumab, benralizumab, mepolizumab, dupilumab, or tezepelumab) for at least 6 months, with no upper limit on the duration of treatment.
Able to understand the informed consent form and willing to consent to participate in a recorded semi-structured interview, as well as to the anonymized processing of their data.
Disqualifiers
Who refuses to participate in the research.
Who is unable to travel to participate in an in-person interview.
Who is under legal guardianship or conservatorship.
Who does not speak French.
Trial population
Patients with severe asthma who have been on biologic therapy for at least 6 months and are being treated at the Angers University Hospital's Pulmonology Department
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Initial assesment interwiew
Other interventionA semi-structured interview lasting about one hour, conducted in an environment designed to put the patient at ease. First, an exploration of the changes that occurred in the patient's life prior to immunotherapy across all aspects of daily life-including social, professional, family, and marital life. Second, an exploration of current difficulties related to the illness while on immunotherapy, and the coping strategies the patient has implemented in various areas of life.
Intake Interview with the Patient
Other interventionAfter two professionals have reviewed the initial double-blind interview, the purpose of this second interview is to confirm with the patient that they have a clear understanding of his or her situation and needs.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Simple group2 interventions
Trial outcomes
Primary outcomes
1
the presence of changes in the lives of people with severe asthma, which will be identified following the analysis of their circumstances.
to analyze changes in the living conditions of patients with severe asthma who have been receiving targeted therapy for at least 6 months, using a person-centered methodology.
Time frame
During the initial interwiewLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: