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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatigue; Inflammatory Bowel Diseases; Remission

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Myriam Coutard; Phone Number: 0476768455; Email: MCoutard@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

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

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing quality of life in IBD patients	Functional visual handicap score based on IBD-Disk visual aid, evaluated at enrollment.	at enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caracterization of patients with chronic bowel disease (IBD) in remission in function of anthropometric and clinical parameters.	Descriptif analysis of IBD patients according to socio demographic and health caracteristics.	at enrollment

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Nicolas Mathieu, Pr, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): September 16, 2024
• Study Completion (Estimated): September 16, 2024

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): January 2, 2024
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Fatigue; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 2023-A01692-43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No