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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Crohn Disease (CD)
• Intervention / Treatment: Other: Semi-structured interview

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Zahra Moussavi; Phone Number: +33 4 76 76 86 41; Email: zmoussavi@chu-grenoble.fr

Study Locations

• France
  • La Tronche, France, 38700
    • Chu Grenoble Alpes
    • Contact: Anna Borowik, PhD; Phone Number: +33 4 76 76 93 14; Email: aborowik@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of patient-reported symptom categories associated with stenosing Crohn's disease, derived from thematic content analysis of single semi-structured interviews.	Up to 5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 38RC25.0402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data (IPD) will not be shared due to the qualitative nature of the study. The data consist of interview transcripts containing health-related information and sensitive personal content. Full anonymization cannot be guaranteed, and data sharing was not covered by the informed consent or the European regulatory framework (GDPR) applicable to this study.