The Effect of Patient Education on Fatigue in Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

— IBD  

Official title:

Evaluation of the Effect of Patient Education on the Management of Fatigue in Individuals With Inflammatory Bowel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05515003
• Other study ID #: Fatigue
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: September 2022
• Source: Istanbul University-Cerrahpasa
• Contact: FATMANUR INCE OZGENEL, RN, MSc
• Phone: 905074498685
• Email: fatmanur_ince[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: Fatigue is a serious symptom that is seen in a significant portion of IBD patients and negatively affects the patient's quality of life. The aim of this study is to evaluate the effect of patient education on the management of fatigue, which is common in inflammatory bowel diseases.

Material and methods: This study will be planned with nonrandomized control group, pretest-posttest design. It is planned that the sample group will consist of at least 84 patients, 42 of which are in the intervention group and 42 in the control group. The patients in the intervention group will be evaluated in terms of fatigue and factors that may affect it, and an individualized education program will be offered according to the needs of the patient.For the patients in the control group, only the scales used in data collection will be filled, and no education will be planned. One month after the first interviews, both groups will fill in the scales again.

Description:

The aim of this study is to evaluate the effect of patient education on the management of fatigue, which is common in inflammatory bowel diseases.This study will be conducted in IBD outpatient clinic in Eskisehir Osmangazi University Hospital. This study will be planned with a nonrandomized control group, pretest-posttest design. Patients who meet the criteria will be assigned to the intervention or control group. It is planned that the sample group will consist of at least 84 patients, 42 of which are in the intervention group and 42 in the control group. The patients in the intervention group will be evaluated in terms of fatigue and factors that may affect it, and an individualized education program will be offered according to the needs of the patient. All patients will be assessed at baseline by use of following tools: Patient Information Form, Crohn's Disease Harvey-Bradshaw Activity Index (HBI), Simple Colitis Clinical Activity Index (SCCAI), Inflammatory Bowel Diseases Fatigue (IBD-F) Scale, Inflammatory Bowel Diseases Quality of Life Assessment Questionnaire. Patients in the intervention group will be applied one-session individualized patient education by the researcher. The control group will be applied usual care. Two groups will be compared at baseline and at the 1st month after the intervention with the same scales

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: October 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Disease in remission

• Diagnosis of inflammatory bowel disease with endoscopic procedures

• Being over 18 years old,

• Patient's volunteering to participate in the research

Exclusion Criteria:

• Having a psychiatric illness,

• Having a diagnosis of chronic fatigue syndrome,

• Difficulty in communicating (speech, perception, understanding problem),

• Having an advanced chronic disease

Related Conditions & MeSH terms

• Fatigue
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• Individualized patient education
Patients in the intervention group will be applied one-session individualized patient education by the researcher. Educational session will last between 30 and 60 minutes. Problem-focused education will be applied related to the issues that the patient had difficulty in coping with. The subjects that the patient lacks knowledge about will be determined and the patient will be trained on these subjects and a discussion session will be arranged in the form of questions and answers. The education topics will include; fatigue, diarrhea/constipation, abdominal pain, mental health, nutrition, exercise and sleep.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University	Eskisehir

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa	Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Inflammatory Bowel Disease Fatigue Patient Self-Assessment Scale scores	Fatigue will be assessed with the Inflammatory Bowel Disease Fatigue Patient Self-Assessment Scale. The scale was developed to diagnose fatigue or to monitor the level of fatigue over time. The scale consists of three sections. A score of 0-20 can be obtained from Section 1. A score of 0 means no fatigue. Therefore, there is no need to complete sections 2 and 3. A score of 1-10 means mild to moderate fatigue, and a score of 11-20 means severe fatigue. A score between 0--120 can be obtained from Section 2. A score of 0 indicates that fatigue does not affect daily activities, a score of 1-60 indicates that it affects it moderately, and a score of 61-120 indicates that it affects it severely. Section 3 is not scored. Higher scores indicate a higher level of fatigue (Section I) or the severity of the impact of fatigue on an individual's life (Section II).	At the baseline, 1st month after the intervention
Secondary	Change in the Inflammatory Bowel Diseases Quality of Life Scale scores	Quality of life will be assessed with the Inflammatory Bowel Disease Quality of Life Questionnaire. Quality of life will be assessed with the Inflammatory Bowel Disease Quality of Life Questionnaire. Scores ranging from 36 to 252 can be obtained from the questionnaire. As the score obtained from the scale increases, the quality of life of the patients also increases.	At the baseline, 1st month after the intervention