Inflammatory Bowel DiseasesIBDNCT05515003
The Effect of Patient Education on Fatigue and Quality of Life in Inflammatory Bowel Disease
A study testing Individualized patient education in people with Inflammatory Bowel Diseases, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Individualized patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 27 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease in remission
- Diagnosis of inflammatory bowel disease with endoscopic procedures
- Being over 18 years old,
- Patient's volunteering to participate in the research
Who cannot join
- Having a psychiatric illness,
- Having a diagnosis of chronic fatigue syndrome,
- Difficulty in communicating (speech, perception, understanding problem),
- Having an advanced chronic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, 26040
About this study
Official title: Evaluation of the Effect of Patient Education on the Management of Fatigue and Quality of Life in Individuals With Inflammatory Bowel Disease
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.
Read the 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
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Individualized patient education
- Keywords
- Fatigue, Quality of life
- Medical subject headings
- Inflammatory Bowel Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized patient educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Education group | Experimental | Individualized patient education Receives: Other: Individualized patient education |
| Control group | No intervention | No training will be provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At the baseline, 1st month after the intervention
Secondary outcomes (1)
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.
Measured: At the baseline, 1st month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Sep 2020
- Primary completion31 May 2022
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Nonrandomized Control Group, Pretest-Posttest Design
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Responsible party
- Principal investigator, Zeliha Tülek, Istanbul University - Cerrahpasa
- Investigators
- ZELIHA TULEK, Assoc.Prof., Study director, Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515003
- Sponsor's protocol ID
- Fatigue
- Acronym
- IBD
- Status last verified
- Jul 2024
- First submitted
- 23 Aug 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ince Ozgenel F, Tulek Z, Temel T. Effect of a nurse-led individualized patient education program on fatigue and quality of life in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2026 Jun 29. doi: 10.1097/MEG.0000000000003241. Online ahead of print.
PubMed 42429197Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Patient Education on the Management of Fatigue and Quality of Life in Individuals With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05515003
- Acronym / sponsor ID
- IBD / Fatigue
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Fatigue, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Nonrandomized Control Group, Pretest-Posttest Design
| Arm | Type | Receives |
|---|---|---|
| Education group | Experimental | Other: Individualized patient educationIndividualized patient education |
| Control group | No intervention | –No training will be provided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Disease in remission
- Diagnosis of inflammatory bowel disease with endoscopic procedures
- Being over 18 years old,
- Patient's volunteering to participate in the research
Key exclusion criteria (4 listed)
- Having a psychiatric illness,
- Having a diagnosis of chronic fatigue syndrome,
- Difficulty in communicating (speech, perception, understanding problem),
- Having an advanced chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized patient educationIn 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. | Other | Education group |
Primary outcome
Change in the Inflammatory Bowel Disease Fatigue Patient Self-Assessment Scale scores
Time frame: At the baseline, 1st month after the intervention
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).
1 secondary outcome
Change in the Inflammatory Bowel Diseases Quality of Life Scale scores
Time frame: At the baseline, 1st month after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 42429197Ince Ozgenel F, Tulek Z, Temel T. Effect of a nurse-led individualized patient education program on fatigue and quality of life in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2026 Jun 29. doi: 10.1097/MEG.0000000000003241. Online ahead of print.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZELIHA TULEK, Assoc.Prof. study director
Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized patient education in people with Inflammatory Bowel Diseases, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Inflammatory Bowel Disease Fatigue Patient Self-Assessment Scale scores (time frame: At the baseline, 1st month after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05515003, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.