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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Anne PINEAU
- 전화번호: +33 241353637
- 이메일: anne.pineau@chu-angers.fr
연구 연락처 백업
- 이름: Anne PINEAU
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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
설명
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.).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
the presence of changes in the lives of people with severe asthma, which will be identified following the analysis of their circumstances.
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Anne PINEAU, University Hospital of Angers
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .