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

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Remission; Fatigue; Inflammatory Bowel Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT06186999

2023-A01692-43

Details and patient eligibility

About

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.

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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