Qualitative Exploration of Key Symptoms of Stricturing Crohn's Disease: Toward the Development of a Clinical Assessment Score.

Обзор

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

Вмешательства

• Другое Semi-structured interview
  One-hour semi-structured interview in person or by videoconference. Interviews will be audio-recorded, pseudonymized, transcribed, and analyzed, and participants can review their transcripts before final anonymization.

Первичные конечные точки

• Frequency of patient-reported symptom categories associated with stenosing Crohn's disease, derived from thematic content analysis of single semi-structured interviews. [Срок оценки: Up to 5 months]

Вторичные конечные точки (5)

• Frequency of patient-reported symptom categories described as early warning signs of a stenosing flare, derived from qualitative content analysis of individual interviews. [Срок оценки: Up to 5 months]
• Frequency of patient-reported daily life impact domains identified through qualitative content analysis of individual interviews. [Срок оценки: Up to 5 months]
• Frequency of patient-reported mental health impact domains identified through qualitative content analysis of individual interviews. [Срок оценки: Up to 5 months]
• Frequency of patient-reported quality-of-life impact domains identified through qualitative content analysis of single semi-structured interviews. [Срок оценки: Up to 5 months]
• Frequency of patient-reported coping strategy categories identified through qualitative content analysis of individual interviews. [Срок оценки: Up to 5 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 1 центр

• CHU Grenoble Alpes — La Tronche

Идентификаторы

NCT: NCT07441629 · 38RC25.0402

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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