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

Primary Purpose

Inflammatory Bowel Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Individualized patient education
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Bowel Diseases focused on measuring Fatigue, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eskisehir Osmangazi UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education group

Control group

Arm Description

Individualized patient education

No training will be provided

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
August 23, 2022
Last Updated
September 4, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05515003
Brief Title
The Effect of Patient Education on Fatigue in Inflammatory Bowel Disease
Acronym
IBD
Official Title
Evaluation of the Effect of Patient Education on the Management of Fatigue in Individuals With Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Fatigue, Quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Nonrandomized Control Group, Pretest-Posttest Design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education group
Arm Type
Experimental
Arm Description
Individualized patient education
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No training will be provided
Intervention Type
Other
Intervention Name(s)
Individualized patient education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Inflammatory Bowel Disease Fatigue Patient Self-Assessment Scale scores
Description
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).
Time Frame
At the baseline, 1st month after the intervention
Secondary Outcome Measure Information:
Title
Change in the Inflammatory Bowel Diseases Quality of Life Scale scores
Description
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.
Time Frame
At the baseline, 1st month after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FATMANUR INCE OZGENEL, RN, MSc
Phone
905074498685
Email
fatmanur_ince@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ZELIHA TULEK, Assoc. Prof.
Phone
902122244986
Ext
27254
Email
ztulek@iuc.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZELIHA TULEK, Assoc.Prof.
Organizational Affiliation
Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Eskisehir Osmangazi University
City
Eskisehir
ZIP/Postal Code
26040
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZELIHA TULEK, Assoc.Prof.
Email
ztulek@iuc.edu.tr
First Name & Middle Initial & Last Name & Degree
FATMANUR İNCE OZGENEL, RN,PhD(c)
Email
fatmanur_ince@hotmail.com
First Name & Middle Initial & Last Name & Degree
Fatmanur INCE OZGENEL, RN,PhD (c)

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Patient Education on Fatigue in Inflammatory Bowel Disease

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