- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07856407
Educational Needs of Patients With Severe Asthma on Targeted Immunotherapies (BASIC)
Educational Needs of Patients With Severe Asthma on Targeted Immunotherapies: A Qualitative Study
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Anne PINEAU
- Telefonní číslo: +33 241353637
- E-mail: anne.pineau@chu-angers.fr
Studijní záloha kontaktů
- Jméno: Anne PINEAU
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
Any person
- 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.
- Who has asthma associated with a systemic disease (GEPA, ABPA, etc.).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: CASE_CONTROL
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Simple group
|
A 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. After 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
the presence of changes in the lives of people with severe asthma, which will be identified following the analysis of their circumstances.
Časové okno: During the initial interwiew
|
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. |
During the initial interwiew
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Anne PINEAU, University Hospital of Angers
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 49RC26_0294
Informace o lécích a zařízeních, studijní dokumenty
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