Clinical trial NCT05515003: The Effect of Patient Education on Fatigue and Quality of Life in Inflammatory Bowel Disease
Official title: Evaluation of the Effect of Patient Education on the Management of Fatigue and Quality of Life in Individuals With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Fatigue
Quality of life
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Eskisehir Osmangazi University
First posted: 2022-08-25
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Nonrandomized Control Group, Pretest-Posttest Design
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Inflammatory Bowel Disease Fatigue Patient Self-Assessment Scale scores
timeFrame: At the baseline, 1st month after the intervention
Secondary outcomes:
measure: Change in the Inflammatory Bowel Diseases Quality of Life Scale scores
timeFrame: At the baseline, 1st month after the intervention
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
Study officials:
affiliation: Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
name: ZELIHA TULEK, Assoc.Prof.
role: STUDY_DIRECTOR
References: