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Completed

NCT Number: NCT06186999

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Fatigue Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Remission Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Bordeaux Hôpital Haut Lévêque, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Description of the relationship : fatigue - social precariousness

    Time frame: at enrollment

    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.

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

    Time frame: at enrollment

    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.

  3. Description of the relationship : demographic determinants - fatigue.

    Time frame: at enrollment

    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.

Secondary outcomes

  1. Assessing quality of life in IBD patients

    Time frame: at enrollment

    Functional visual handicap score based on IBD-Disk visual aid, evaluated at enrollment.

Other outcomes

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

    Time frame: at enrollment

    Descriptif analysis of IBD patients according to socio demographic and health caracteristics.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: SOFA

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 2, 2024
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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