Social and Demographic Determinants of Fatigue in Patients With Inflammatory Bowel Disease in Remission

Completed

• Conditions: Inflammatory Bowel Diseases; Remission; Fatigue

• Registration Number: NCT06186999
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The aim of this observational study is to identify the social and demographic determinants of fatigue in patients with inflammatory bowel disease in remission.

Secondly, the objectives of the study are to:

* Assess the impact of fatigue on the quality of life of patients with inflammatory bowel disease in remission.

* To determine the profile of patients with inflammatory bowel disease in remission who are fatigued.

To this end, during a consultation or hospitalization, participants will be asked to respond independently to various questionnaires (FACIT-F, DIPCare, SSQ6, questionnaire on socio-demographic determinants and IBD disk). Characteristics of the type of chronic inflammatory bowel disease will be collected from medical records.

There will be no patient follow-up as part of the study. Participants may be contacted by telephone by the center's investigator within 2 weeks of the interview in the event of a partial or imprecise response.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-12-15
• Study First Posted: 2024-01-02
• Study Start: 2024-01-17
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient in clinical remission for at least 6 months:

  • for Crohn's disease patients: Harvey Bradshaw Index (HBI) score ≤ 4
  • for patients with ulcerative colitis: a partial Mayo score (PMS) ≤ 2 with each subscore of 1 or less)

• Patient in biological remission for at least 6 months fecal calprotectin <250 μg/g and CRP <5 mg/

• Documented diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic and histological criteria

• FACIT-F score < 40 (defining significant fatigue)

• Subjects at least 18 years of age at the time of study inclusion

Exclusion Criteria

• Severe acute colitis
• Active infection with HIV, hepatitis B, hepatitis C, or untreated tuberculosis
• Patient(s) objecting to the use of their data for research purposes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of the relationship : patient social support - fatigue.	at enrollment	Description of the relationship between patient social support (availability and satisfaction of the patient's entourage) assessed by the "SARASON" (or "SSQ6") questionnaire and fatigue assessed by the FACIT-F questionnaire in patients with inflammatory bowel disease in remission.
Description of the relationship : demographic determinants - fatigue.	at enrollment	Description of the relationship between demographic determinants assessed by the questionnaire, and fatigue assessed by the FACIT-F questionnaire in patients with inflammatory bowel disease in remission.
Description of the relationship : fatigue - social precariousness	at enrollment	Description of the relationship between social precariousness assessed by the "DiPCare" questionnaire and fatigue assessed by the FACIT-F questionnaire in patients with inflammatory bowel disease in remission.

Secondary Outcome Measures

Name	Time	Method
Assessing quality of life in IBD patients	at enrollment	Functional visual handicap score based on IBD-Disk visual aid, evaluated at enrollment.

Trial Locations

Locations (4)

CHU Bordeaux Hôpital Haut Lévêque; 🇫🇷 Bordeaux, France

CHUGA; 🇫🇷 Grenoble, France

Chu Montpellier; 🇫🇷 Montpellier, France

Chu Lyon Sud _ Hcl; 🇫🇷 Lyon, France