Social and Demographic Determinants of Fatigue in Patients With Inflammatory Bowel Disease in Remission
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Description of the relationship : patient social support - fatigue.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Description of the relationship : patient social support - fatigue.
时间窗: 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.
Description of the relationship : demographic determinants - fatigue.
时间窗: 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.
Description of the relationship : fatigue - social precariousness
时间窗: 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.
次要结局
- Assessing quality of life in IBD patients(at enrollment)