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Nationwide Survey of Telemedicinal Patient Education in IBD

29 juin 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

432

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Hongrie
      • Szeged, Hongrie, 6725
        • University Of Szeged

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • IBD patients
  • age ≥18 years

Exclusion Criteria:

  • withdrawing consent

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: CONT (Control)
The group not receiving any educational content.
Expérimental: READ (Written PDF Document)
The group receiving the educational content in the form of a written PDF document.
Autre: 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.
Expérimental: HEAR (Audio Podcast)
The group receiving the educational content in the form of an audio podcast.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Extended Inflammatory Bowel Disease Knowledge (IBD-KNOW) Questionnaire
Délai: 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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Likert Scale for Participant Satisfaction With Educational Content
Délai: 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
Délai: 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
Délai: 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
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Szeged University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 octobre 2024

Achèvement primaire (Réel)

31 décembre 2025

Achèvement de l'étude (Réel)

31 décembre 2025

Dates d'inscription aux études

Première soumission

21 mai 2026

Première soumission répondant aux critères de contrôle qualité

29 juin 2026

Première publication (Réel)

30 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BM/21110-3/2023

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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