NCT07441629尚未招募不适用
Qualitative Exploration of Key Symptoms of Stricturing Crohn's Disease: Toward the Development of a Clinical Assessment Score.
University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年5月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Frequency of patient-reported symptom categories associated with stenosing Crohn's disease, derived from thematic content analysis of single semi-structured interviews.
研究概览
简要总结
The goal of this qualitative study is to identify and better understand the symptoms of stricturing Crohn's disease in order to inform the development of more appropriate clinical evaluation scores. This study focuses on adult patients diagnosed with stricturing Crohn's disease who are followed in hospital gastroenterology departments.
The main questions it aims to answer are:
- Which symptoms are perceived by patients as the most specific and significant features of stenosing Crohn's disease?
- Which symptoms are perceived by patients as early warning signs of a stenosing flare?
- How does stenosing Crohn's disease impact daily life, mental health, and quality of life, and what coping strategies do patients use to manage symptoms and limit their impact?
Participants will:
- Take part in a one-hour individual semi-structured interview, conducted in person (at the hospital, at home, or in another agreed location) or by videoconference
- Have the interview audio-recorded for transcription and qualitative analysis
- Be offered the opportunity to review and validate the transcript and summary of their interview before final anonymized analysis
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (≥ 18 years old).
- •With a confirmed diagnosis of Crohn's disease.
- •Presenting a stricturing form of the disease (confirmed clinically, endoscopically, radiologically, or surgically).
- •Followed in a hospital department managing inflammatory bowel diseases (IBD).
- •Clinically stable at the time of the interview (not experiencing an acute episode requiring urgent hospitalization).
- •Able to understand and speak French, in order to participate in a qualitative interview.
排除标准
- •Current hospitalization for a severe Crohn's disease flare, acute intestinal obstruction, or any situation requiring urgent medical care.
- •Severe cognitive impairment, communication deficits, or acute psychiatric disorder preventing understanding of the interview or reliable expression of experiences.
- •Major uncontrolled medical comorbidity (e.g., active cancer under treatment, severe heart failure) making the interview inappropriate or likely to confound symptom interpretation.
- •Technical inability to participate in an interview (no access to the proposed modalities: unable to travel, no access to videoconference if a remote interview is required).
- •Pregnant women
- •Persons deprived of their liberty
- •Persons receiving psychiatric care
- •Persons admitted to a healthcare or social institution
- •Adults subject to a legal protection measure
- •Persons unable to express their consent
结局指标
主要结局
Frequency of patient-reported symptom categories associated with stenosing Crohn's disease, derived from thematic content analysis of single semi-structured interviews.
时间窗: Up to 5 months
次要结局
- Frequency of patient-reported symptom categories described as early warning signs of a stenosing flare, derived from qualitative content analysis of individual interviews.(Up to 5 months)
- Frequency of patient-reported daily life impact domains identified through qualitative content analysis of individual interviews.(Up to 5 months)
- Frequency of patient-reported mental health impact domains identified through qualitative content analysis of individual interviews.(Up to 5 months)
- Frequency of patient-reported quality-of-life impact domains identified through qualitative content analysis of single semi-structured interviews.(Up to 5 months)
- Frequency of patient-reported coping strategy categories identified through qualitative content analysis of individual interviews.(Up to 5 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Acute Effects of Intravenous 5-MeO-DMT in Healthy ParticipantsNCT07444788University Hospital, Basel, Switzerland40
已完成
不适用
Screening of Adductor Related Symptoms in Adolescent Taekwondo AthletesNCT07410273Izmir Democracy University80
招募中
不适用
A Prospective Observational Study Evaluating the Incidence of Silent Cerebral Lesions and Procedural Safety Following Atrial Fibrillation Ablation Using the VARIPULSE™ Pulsed Field Ablation SystemNCT07363278Seoul National University Hospital40
已完成
不适用
Acute Impact of Static, Dynamic, and Proprioceptive Exercises on Proprioception, Strength, Balance, and Explosive PowerNCT07320027Konya Necmettin Erbakan Üniversitesi48
招募中
不适用
Post Facilitatiion Stretch and Dry Needling on Hamstring Tightness in Chronic Low Back PainNCT07426562Riphah International University36