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

Fatigue Clinical Trial

— SOFA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06186999
• Other study ID #: 2023-A01692-43
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: September 16, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Grenoble
• Contact: Myriam Coutard
• Phone: 0476768455
• Email: MCoutard[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 16, 2024
• Est. primary completion date: September 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Remission

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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	Assessing quality of life in IBD patients	Functional visual handicap score based on IBD-Disk visual aid, evaluated at enrollment.	at enrollment