Evolution of Fatigue in Patients With Inflammatory Bowel Disease

NCT04189692 | Unknown

• 1 other identifier: HMT3
• Study Type: observational
• Target: 202
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fatigue; Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Keywords

Fatigue;; Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Evaluate the evolution of fatigue in patients with Inflammatory Bowel Disease at 3 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

Secondary Outcomes (3)

• Assess the biological factors associated with the persistence of fatigue

  three years

• Assess the psychological factors associated with the persistence of fatigue

  three years

• Assess the psychological factors associated with the persistence of fatigue

  three years

Study Arms (1)

Patients with Inflammatory Bowel Disease and fatigue

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Related Publications (2)

• Villoria A, Garcia V, Dosal A, Moreno L, Montserrat A, Figuerola A, Horta D, Calvet X, Ramirez-Lazaro MJ. Fatigue in out-patients with inflammatory bowel disease: Prevalence and predictive factors. PLoS One. 2017 Jul 27;12(7):e0181435. doi: 10.1371/journal.pone.0181435. eCollection 2017.

  PMID: 28749985 BACKGROUND

• Horta D, Lira A, Sanchez-Lloansi M, Villoria A, Teggiachi M, Garcia-Rojo D, Garcia-Molina S, Figuerola A, Esteve M, Calvet X. A Prospective Pilot Randomized Study: Electroacupuncture vs. Sham Procedure for the Treatment of Fatigue in Patients With Quiescent Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020 Feb 11;26(3):484-492. doi: 10.1093/ibd/izz091.

  PMID: 31091322 BACKGROUND

MeSH Terms

Conditions

Fatigue; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Diana Horta

  Parc Tauli Hospital. Sabadell , Barcelona, Spain, 08208

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Horta

CONTACT

93 745 84 54; diana.horta.s@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: gastroenterologist physician

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: December 6, 2019
• Study Start: January 7, 2020
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: December 6, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share