Nationwide Survey of Telemedicinal Patient Education in IBD

NCT07675369 | Completed

• 1 other identifier: BM/21110-3/2023
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

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

Conditions

IBD (Inflammatory Bowel Disease)

Keywords

IBD; education

Outcome Measures

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.

  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

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

• Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Follow-up

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

• Patient Health Questionnaire-9 (PHQ-9) Follow-up

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

• Disease activity Follow-up

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

Study Arms (3)

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.

Other: Written PDF Document

HEAR (Audio Podcast)

EXPERIMENTAL

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

Other: Audio Podcast.

Interventions

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.

READ (Written PDF Document)

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.

HEAR (Audio Podcast)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IBD patients
• age ≥18 years

You may not qualify if:

• withdrawing consent

Sponsors & Collaborators

• Szeged University: lead

Study Sites (1)

University of Szeged

Szeged, 6725, Hungary

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 30, 2026
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 30, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)