Skip to main content
OpenTrials
Completed

NCT Number: NCT07675369

Nationwide Survey of Telemedicinal Patient Education in IBD

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

IBD (Inflammatory Bowel Disease) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Szeged

Szeged, 6725, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • IBD patients
  • age ≥18 years

Exclusion criteria

  • withdrawing consent

Treatment and study plan

Written PDF Document

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Likert Scale for Participant Satisfaction With Educational Content

    Time frame: 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.

  2. Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Follow-up

    Time frame: 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.

  3. Patient Health Questionnaire-9 (PHQ-9) Follow-up

    Time frame: 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.

  4. Disease activity Follow-up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Szeged University

Other

Registry information

Official study title

Nationwide Survey of Telemedicinal Patient Education in IBD - Baseline Knowledge Gaps and a Randomized Comparison of Podcast Versus Written Format

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.