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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06186999
Acronym
SOFA
Enrollment
208
Registered
2024-01-02
Start date
2024-01-17
Completion date
2024-06-24
Last updated
2025-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Inflammatory Bowel Diseases, Remission

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.

Interventions

None listed

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Description of the relationship : fatigue - social precariousnessat enrollmentDescription 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.
Description of the relationship : patient social support - fatigue.at enrollmentDescription 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 enrollmentDescription 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.

Secondary

MeasureTime frameDescription
Assessing quality of life in IBD patientsat enrollmentFunctional visual handicap score based on IBD-Disk visual aid, evaluated at enrollment.

Other

MeasureTime frameDescription
Caracterization of patients with chronic bowel disease (IBD) in remission in function of anthropometric and clinical parameters.at enrollmentDescriptif analysis of IBD patients according to socio demographic and health caracteristics.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026