The Effect of Patient Education on Fatigue and Quality of Life in Inflammatory Bowel Disease

NCT05515003 | Completed

• 1 other identifier: Fatigue
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

Fatigue; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in the Inflammatory Bowel Diseases Quality of Life Scale scores

  At the baseline, 1st month after the intervention

Study Arms (2)

Education group

EXPERIMENTAL

Individualized patient education

Other: Individualized patient education

Control group

NO INTERVENTION

No training will be provided

Interventions

Individualized patient education OTHER

In the intervention group, patients will undergo a single, personalized education session led by the researcher, lasting 30 to 60 minutes. Identified knowledge gaps will be addressed through focused education, followed by interactive question-and-answer sessions covering fatigue, diarrhea/constipation, abdominal pain, mental health, nutrition, exercise, and sleep. Follow-up calls will be conducted in the 1st, 2nd, and 3rd weeks post-education to monitor patient progress. Each call will assess general health status, symptom severity, and changes in bowel habits. Patients will be encouraged to review educational materials and ask questions, with appointment reminders provided during the 3rd week. These calls will each last approximately 10-15 minutes. One month later, follow-up interviews will evaluate the education's impact using updated data collection tools, ensuring a thorough assessment of its effect on patient outcomes.

Education group

Eligibility Criteria

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

You may qualify if:

• Disease in remission
• Diagnosis of inflammatory bowel disease with endoscopic procedures
• Being over 18 years old,
• Patient's volunteering to participate in the research

You may not qualify if:

• Having a psychiatric illness,
• Having a diagnosis of chronic fatigue syndrome,
• Difficulty in communicating (speech, perception, understanding problem),
• Having an advanced chronic disease

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Eskisehir Osmangazi University: collaborator

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, 26040, Turkey (Türkiye)

Location

Related Publications (1)

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

  PMID: 40243391 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Fatigue

Condition Hierarchy (Ancestors)

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

Study Officials

• ZELIHA TULEK, Assoc.Prof.

  Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN,Assoc Prof

Model Details: Nonrandomized Control Group, Pretest-Posttest Design

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: September 1, 2020
• Primary Completion: May 31, 2022
• Study Completion: September 27, 2023
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)