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Evolution of Fatigue in Patients With Inflammatory Bowel Disease

2019年12月5日 更新者:Diana Horta-Sangenis、Corporacion Parc Tauli
The aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent IBD and fatigue included in two previous studies.

研究概览

详细说明

Fatigue is a common symptom in inflammatory bowel disease and persists despite clinical remission. Fatigue in patients with chronic diseases can be objectified by the FACIT-F scale.

Recent publications have tried to assess the prevalence and factors related to fatigue in patients with IBD.

In 2017 one study evaluated the prevalence and predictive factors of fatigue in out-patients with inflammatory bowel disease. Fatigue was associated with depression, low quality of life and female sex. No association was found with micronutrients or levels of interleukins.

As there are no effective treatments for fatigue in IBD, another study, recently published a study evaluating the role of electroacupuncture in 54 patients with quiescent IBD and fatigue, observing that both electroacupuncture and sham acupuncture improved fatigue compared to the control group.

The aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent IBD and fatigue included in the two previous studies.

Patients with inflammatory bowel disease and fatigue (FACIT-F score < 40) included in these two previous studies who agree to participate will fill in questionnaires to assess fatigue, anxiety, depression and quality of life in inflammatory bowel disease. Moreover, the relationship of other biological factors with IBD-related fatigue will be determined.

研究类型

观察性的

注册 (预期的)

202

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All patients with IBD and fatigue included in the two previous studies (1,2) (n = 202) who agree to participate.

描述

Inclusion Criteria:

  • Patients with inflammatory bowel disease and fatigue (defined as a FACIT-F score <40 points) previously documented in our two previous studies.
  • Written informed consent after receiving clear and objective information about the purpose and characteristics of the study.
  • Ability to understand the questionnaires.

Exclusion Criteria:

  • Associated tumor disease.
  • Pregnancy or breastfeeding.
  • Anemia (hemoglobin <12g/dl in women and 14g/dl in men)
  • Any concomitant illness that may justify the presence of fatigue.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Patients with Inflammatory Bowel Disease and fatigue
Patients with Inflammatory Bowel Disease and fatigue that participated in the two studies (1,2).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Evaluate the evolution of fatigue in patients with Inflammatory Bowel Disease at 3 years
大体时间:three years
Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F scale). This questionnaire, previously validated in Spanish and for IBD patients, comprises 40 items divided into five subscales: Physical wellbeing (PWB), Social/family wellbeing (SWB), Emotional wellbeing (EWB), Functional Wellbeing (FWB), and Fatigue subscale. The first four subscales (27 items) evaluate general features of chronic illness, and the 13 items of the Fatigue subscale specifically focus on fatigue. Each item has five possible answers, from 0 (very fatigued) to 4 (not at all fatigued). The score of each subscale is the sum of the coded values of its items.
three years

次要结果测量

结果测量
措施说明
大体时间
Assess the biological factors associated with the persistence of fatigue
大体时间:three years
Assessed by a blood test including micronutrients (vitamin B12, ferritin and vitamin D).
three years
Assess the psychological factors associated with the persistence of fatigue
大体时间:three years
Assessed by the Beck Depression Inventory (BDI) questionnaire. The Spanish validated 21-item version of the BDI will be used to analyze depression. This self-administered questionnaire evaluates the clinical features of melancholy and intrusive thoughts present in depression. Each item has a different number of options (from 4 to 8), which then have to be converted into four possible values (0, 1, 2, or 3). Higher BDI scores indicate a higher grade of depression.
three years
Assess the psychological factors associated with the persistence of fatigue
大体时间:three years
Assessed by Quality of life in inflammatory bowel disease questionnaire (IBDQ-9). he IBDQ-9 consists of nine items assessing different aspects of life in IBD patients. Each item has seven different possible answers, scoring from 1 (poorest) to 7 (best). The straight summation of all nine items provides a direct score, which is then transformed into a final score. Higher scores correspond to a better quality of life.
three years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Diana Horta、Parc Tauli Hospital. Sabadell , Barcelona, Spain, 08208

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2020年1月7日

初级完成 (预期的)

2020年12月7日

研究完成 (预期的)

2020年12月7日

研究注册日期

首次提交

2019年11月14日

首先提交符合 QC 标准的

2019年12月5日

首次发布 (实际的)

2019年12月6日

研究记录更新

最后更新发布 (实际的)

2019年12月6日

上次提交的符合 QC 标准的更新

2019年12月5日

最后验证

2019年12月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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