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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial population

Adult patient (≥ 18 years old), with a confirmed diagnosis of Crohn's disease presenting a stricturing form of the disease

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Semi-structured interview

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Frequency of patient-reported symptom categories associated with stenosing Crohn's disease, derived from thematic content analysis of single semi-structured interviews.

Time frame
Up to 5 months

Secondary outcomes

1

Frequency of patient-reported symptom categories described as early warning signs of a stenosing flare, derived from qualitative content analysis of individual interviews.

Time frame
Up to 5 months
2

Frequency of patient-reported daily life impact domains identified through qualitative content analysis of individual interviews.

Time frame
Up to 5 months
3

Frequency of patient-reported mental health impact domains identified through qualitative content analysis of individual interviews.

Time frame
Up to 5 months
4

Frequency of patient-reported quality-of-life impact domains identified through qualitative content analysis of single semi-structured interviews.

Time frame
Up to 5 months

Other outcomes

Sponsors and contacts

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