Evolution of Fatigue in Patients With Inflammatory Bowel Disease
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 202
- Primary Endpoint
- Evaluate the evolution of fatigue in patients with Inflammatory Bowel Disease at 3 years
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Evaluate the evolution of fatigue in patients with Inflammatory Bowel Disease at 3 years
Time Frame: 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.
Secondary Outcomes
- Assess the psychological factors associated with the persistence of fatigue(three years)
- Assess the biological factors associated with the persistence of fatigue(three years)
Investigators
Diana Horta-Sangenis
gastroenterologist physician
Corporacion Parc Tauli