IBD (Inflammatory Bowel Disease)
Conditions
Keywords
IBD, education
Brief summary
The goal of this clinical trial is to learn if simple, easy-to-use educational materials can help people with inflammatory bowel disease (IBD) better understand their condition. The study will also look at how people feel about using these materials and if the education affects their daily life and well-being. The main questions it aims to answer are: * Does the education help people score higher on the IBD-KNOW questionnaire after three months * How satisfied are people with the written or audio materials * Does the education affect quality of life, mental health, or IBD disease activity Researchers will compare written and audio education to see which format works better for learning and user experience. Participants will: * Fill out questionnaires at the start of the study and again after three months * Receive written or audio educational materials if they are in one of the education groups * Complete short surveys about quality of life, mental health, and IBD symptoms if they receive the educational materials
Interventions
OTHERWritten PDF Document
A structured written PDF booklet covering key domains of inflammatory bowel disease, including anatomy, physiology, etiology, risk factors, pathology, diagnosis, treatments and targets, monitoring, surgeries, pregnancy, and vaccines. The material is explicitly designed to address all questions related to the IBD-KNOW questionnaire, and was developed by expert gastroenterologists, ensuring comprehensive educational coverage.
OTHERAudio Podcast.
A structured audio podcast covering key domains of inflammatory bowel disease, including anatomy, physiology, etiology, risk factors, pathology, diagnosis, treatments and targets, monitoring, surgeries, pregnancy, and vaccines. The material is explicitly designed to address all questions related to the IBD-KNOW questionnaire, and was developed by expert gastroenterologists, ensuring comprehensive educational coverage.
Sponsors
Szeged University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* IBD patients * age ≥18 years
Exclusion criteria
* withdrawing consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extended Inflammatory Bowel Disease Knowledge (IBD-KNOW) Questionnaire | Three months after enrollment (CONT group) or receiving the educational material (READ and HEAR groups). | Change in the scores of the 35-item extended Inflammatory Bowel Disease Knowledge (IBD-KNOW) questionnaire to assess knowledge retention and evaluate user experience. The original IBD-KNOW questionnaire is a validated tool for measuring disease-related knowledge among patients with inflammatory bowel disease. It consists of 24 items covering anatomy and function, epidemiology, diet and lifestyle, general IBD knowledge, medications, complications, surgeries, pregnancy, and vaccinations. For this study, 11 additional items (items 25-35) were developed by IBD expert gastroenterologists to assess knowledge related to treatment, monitoring, and follow-up strategies. All items use simple True / False / Do not know response options. Total scores range from 0 to 35 points, with higher scores indicating better disease-related knowledge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Likert Scale for Participant Satisfaction With Educational Content | Three months after receiving the educational material (READ and HEAR groups). | Participant satisfaction with the educational material is measured using a 0-10 Likert scale to provide standardized, objective assessment of user experience. The scale ranges from 0 (not satisfied at all) to 10 (extremely satisfied), with higher scores indicating greater satisfaction with the educational content. |
| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Follow-up | Three months after receiving the educational material (READ and HEAR groups). | A follow-up questionnaire assessing patients' subjective experiences with telemedical education and its impact on quality of life using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). The SIBDQ is a validated self-reported measure of health-related quality of life in IBD, consisting of 10 items, each rated on a 1-7 Likert scale. Total scores range from 10 to 70, with higher scores indicating better health-related quality of life. |
| Patient Health Questionnaire-9 (PHQ-9) Follow-up | Three months after receiving the educational material (READ and HEAR groups). | A follow-up questionnaire assessing patients' subjective experiences with telemedical education and its impact on mental health using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a validated, self-administered 9-item depression severity scale, with each item scored from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. An additional functional-impairment item asks how difficult the reported problems have made it for patients to work, manage household responsibilities, or interact with others. |
| Disease activity Follow-up | Three months after receiving the educational material (READ and HEAR groups). | A follow-up questionnaire assessing patients' subjective experiences with telemedical education and its impact on disease activity. Participants rate agreement (Agree / Do not agree) with statements regarding lifestyle modification, disease management, frequency of flares and overall quality of life. |
Countries
Hungary
Outcome results
None listed