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

NCT05515003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-07-30

No results posted yet for this study

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

Interventions

OTHER

Individualized patient education

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.

Sponsors & Collaborators

  • Eskisehir Osmangazi University

    collaborator OTHER

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • ZELIHA TULEK, Assoc.Prof. · Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-05-31
Completion
2023-09-27

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05515003 on ClinicalTrials.gov