IBD (Inflammatory Bowel Disease)NCT07675369
Nationwide Survey of Telemedicinal Patient Education in IBD
A study testing Written PDF Document and Audio Podcast. in people with IBD (Inflammatory Bowel Disease), run by Szeged University at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD (Inflammatory Bowel Disease)
- What is being tested?
- Written PDF Document and Audio Podcast.
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteHungary
- Study dates
- 1 Oct 2024to 31 Dec 2025
- 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
- IBD patients
- age ≥18 years
Who cannot join
- withdrawing consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nationwide Survey of Telemedicinal Patient Education in IBD - Baseline Knowledge Gaps and a Randomized Comparison of Podcast Versus Written Format
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
- Conditions
- IBD (Inflammatory Bowel Disease)
- Being tested
- Written PDF Document, Audio Podcast.
- Keywords
- IBD, education
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written PDF DocumentOther
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.
Audio Podcast.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| CONT (Control) | No intervention | The group not receiving any educational content. |
| READ (Written PDF Document) | Experimental | The group receiving the educational content in the form of a written PDF document. Receives: Other: Written PDF Document |
| HEAR (Audio Podcast) | Experimental | The group receiving the educational content in the form of an audio podcast. Receives: Other: Audio Podcast. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extended Inflammatory Bowel Disease Knowledge (IBD-KNOW) Questionnaire
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.
Measured: Three months after enrollment (CONT group) or receiving the educational material (READ and HEAR groups).
Secondary outcomes (4)
Likert Scale for Participant Satisfaction With Educational Content
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.
Measured: Three months after receiving the educational material (READ and HEAR groups).
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Follow-up
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.
Measured: Three months after receiving the educational material (READ and HEAR groups).
Patient Health Questionnaire-9 (PHQ-9) Follow-up
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.
Measured: Three months after receiving the educational material (READ and HEAR groups).
Disease activity Follow-up
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.
Measured: Three months after receiving the educational material (READ and HEAR groups).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Oct 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675369
- Sponsor's protocol ID
- BM/21110-3/2023
- Status last verified
- Oct 2026
- First submitted
- 21 May 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Survey of Telemedicinal Patient Education in IBD - Baseline Knowledge Gaps and a Randomized Comparison of Podcast Versus Written Format
- ClinicalTrials.gov ID
- NCT07675369
- Acronym / sponsor ID
- BM/21110-3/2023
- Conditions
- IBD (Inflammatory Bowel Disease)
- Keywords
- IBD, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 Jun 2026 (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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONT (Control) | No intervention | –The group not receiving any educational content. |
| READ (Written PDF Document) | Experimental | Other: Written PDF DocumentThe group receiving the educational content in the form of a written PDF document. |
| HEAR (Audio Podcast) | Experimental | Other: Audio Podcast.The group receiving the educational content in the form of an audio podcast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IBD patients
- age ≥18 years
Key exclusion criteria (1 listed)
- withdrawing consent
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 |
|---|---|---|
| Written PDF DocumentA 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. | Other | READ (Written PDF Document) |
| Audio 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. | Other | HEAR (Audio Podcast) |
Primary outcome
Extended Inflammatory Bowel Disease Knowledge (IBD-KNOW) Questionnaire
Time frame: 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.
4 secondary outcomes
Likert Scale for Participant Satisfaction With Educational Content
Time frame: Three months after receiving the educational material (READ and HEAR groups).
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Follow-up
Time frame: Three months after receiving the educational material (READ and HEAR groups).
Patient Health Questionnaire-9 (PHQ-9) Follow-up
Time frame: Three months after receiving the educational material (READ and HEAR groups).
Disease activity Follow-up
Time frame: Three months after receiving the educational material (READ and HEAR groups).
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 29 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written PDF Document and Audio Podcast. in people with IBD (Inflammatory Bowel Disease), run by Szeged University at 1 site in Hungary.
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 2 inclusion and 1 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 29 Oct 2026. 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 Hungary. 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?
Extended Inflammatory Bowel Disease Knowledge (IBD-KNOW) Questionnaire (time frame: Three months after enrollment (CONT group) or receiving the educational material (READ and HEAR groups).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.