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

NCT06186999 | Completed

• 1 other identifier: 2023-A01692-43
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 4

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.

Conditions

Inflammatory Bowel Diseases; Remission; Fatigue

Outcome Measures

Primary Outcomes (3)

• Description of the relationship : fatigue - social precariousness

  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.

  at enrollment

• Description of the relationship : patient social support - fatigue.

  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.

  at enrollment

• Description of the relationship : demographic determinants - fatigue.

  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.

  at enrollment

Secondary Outcomes (1)

• Assessing quality of life in IBD patients

  at enrollment

Other Outcomes (1)

• Caracterization of patients with chronic bowel disease (IBD) in remission in function of anthropometric and clinical parameters.

  at enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study concerns patients with chronic inflammatory bowel disease in remission, such as Crohn's disease or ulcerative colitis.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (4)

CHU Bordeaux Hôpital Haut Lévêque

Bordeaux, France

Location

CHUGA

Grenoble, France

Location

Chu Lyon Sud _ Hcl

Lyon, France

Location

Chu Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Fatigue

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas Mathieu, Pr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: January 2, 2024
• Study Start: January 17, 2024
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

FR (4)