CClinicalTrials.gg
CompletedNCT07675369Updated Jun 30, 2026

Nationwide Survey of Telemedicinal Patient Education in IBD

An interventional study of Written PDF Document and Audio Podcast. in IBD (Inflammatory Bowel Disease), sponsored by Szeged University. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Szeged University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Oct 2024, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
432
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • IBD (Inflammatory Bowel Disease)

Keywords

  • IBD
  • education
03

In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.

This study's enrollment of 432 is above the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Szeged University is the lead sponsor of 53 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • IBD patients
  • age ≥18 years

Exclusion criteria

Exclusion Criteria:

  • withdrawing consent
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
432 participants (actual)

Study arms

  • No intervention
    CONT (Control)

    The group not receiving any educational content.

  • Experimental
    READ (Written PDF Document)

    The group receiving the educational content in the form of a written PDF document.

    Other: Written PDF Document

  • Experimental
    HEAR (Audio Podcast)

    The group receiving the educational content in the form of an audio podcast.

    Other: Audio Podcast.

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Three months after enrollment (CONT group) or receiving the educational material (READ and HEAR groups).

Secondary outcomes

  1. 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.

    Time frame: Three months after receiving the educational material (READ and HEAR groups).

  2. 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.

    Time frame: Three months after receiving the educational material (READ and HEAR groups).

  3. 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.

    Time frame: Three months after receiving the educational material (READ and HEAR groups).

  4. 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.

    Time frame: Three months after receiving the educational material (READ and HEAR groups).

07

Study locations

1 site
  • University of Szeged
    Szeged, 6725, Hungary
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07675369
Lead sponsor
Szeged University
Responsible party
Sponsor
First posted
Jun 30, 2026
Start date
Oct 1, 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Jun 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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