Nationwide Survey of Telemedicinal Patient Education in IBD

June 29, 2026 updated by: Szeged University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

432

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Szeged, Hungary, 6725
        • University of Szeged

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • IBD patients
  • age ≥18 years

Exclusion Criteria:

  • withdrawing consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Experimental: HEAR (Audio Podcast)
The group receiving the educational content in the form of an audio podcast.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three months after enrollment (CONT group) or receiving the educational material (READ and HEAR groups).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).

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.
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).

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.
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).

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Szeged University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BM/21110-3/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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