Clinical trial NCT06186999: Social and Demographic Determinants of Fatigue in Patients With Inflammatory Bowel Disease in Remission
Official title: Social and Demographic Determinants of Fatigue in Patients With Inflammatory Bowel Disease in Remission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Remission
Fatigue
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Description of the relationship : fatigue - social precariousness
timeFrame: at enrollment
measure: Description of the relationship : patient social support - fatigue.
timeFrame: at enrollment
measure: Description of the relationship : demographic determinants - fatigue.
timeFrame: at enrollment
Secondary outcomes:
measure: Assessing quality of life in IBD patients
timeFrame: at enrollment
Other outcomes:
measure: Caracterization of patients with chronic bowel disease (IBD) in remission in function of anthropometric and clinical parameters.
timeFrame: at enrollment
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux Hôpital Haut Lévêque
city: Grenoble
country: France
facility: CHUGA
city: Lyon
country: France
facility: Chu Lyon Sud _ Hcl
city: Montpellier
country: France
facility: Chu Montpellier
Study officials:
affiliation: University Hospital, Grenoble
name: Nicolas Mathieu, Pr
role: PRINCIPAL_INVESTIGATOR
References: