IBD: The Effect of Patient Education on Fatigue in Inflammatory Bowel Disease

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Recruiting
CT.gov ID
NCT05515003
Collaborator
Eskisehir Osmangazi University (Other)
84
1
2
28.9
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Individualized patient education
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Nonrandomized Control Group, Pretest-Posttest DesignNonrandomized Control Group, Pretest-Posttest Design
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of the Effect of Patient Education on the Management of Fatigue in Individuals With Inflammatory Bowel Disease
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Education group

Individualized patient education

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.

No Intervention: Control group

No training will be provided

Outcome Measures

Primary Outcome Measures

  1. Change in the Inflammatory Bowel Disease Fatigue (IBD-F) Patient Self-Assessment Scale scores [At the baseline, 1st month after the intervention]

    Fatigue will be assessed with the Inflammatory Bowel Disease Fatigue (IBD-F) Patient Self-Assessment Scale

Secondary Outcome Measures

  1. Change in the Inflammatory Bowel Diseases Quality of Life Scale scores [At the baseline, 1st month after the intervention]

    Quality of life will be assessed with the Inflammatory Bowel Diseases Quality of Life Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eskisehir Osmangazi University Eskisehir Turkey 26040

Sponsors and Collaborators

  • Istanbul University-Cerrahpasa
  • Eskisehir Osmangazi University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeliha Tülek, RN,Assoc Prof, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier:
NCT05515003
Other Study ID Numbers:
  • Fatigue
First Posted:
Aug 25, 2022
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zeliha Tülek, RN,Assoc Prof, Istanbul University-Cerrahpasa
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022