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

I

Istanbul University - Cerrahpasa (IUC)

Status

Completed

Conditions

Inflammatory Bowel Diseases

Treatments

Other: Individualized patient education

Study type

Interventional

Funder types

Other

Identifiers

NCT05515003
Fatigue

Details and patient eligibility

About

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.

Full 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

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

84 participants in 2 patient groups

Education group
Experimental group
Description:
Individualized patient education
Treatment:
Other: Individualized patient education
Control group
No Intervention group
Description:
No training will be provided

Trial contacts and locations

1

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Central trial contact

ZELIHA TULEK, Assoc. Prof.; FATMANUR INCE OZGENEL, RN, MSc

Data sourced from clinicaltrials.gov

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