Nationwide Survey of Telemedicinal Patient Education in IBD
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Szeged, Hongarije, 6725
- University Of Szeged
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- IBD patients
- age ≥18 years
Exclusion Criteria:
- withdrawing consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: CONT (Control)
The group not receiving any educational content.
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Experimenteel: READ (Written PDF Document)
The group receiving the educational content in the form of a written PDF document.
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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.
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Experimenteel: HEAR (Audio Podcast)
The group receiving the educational content in the form of an audio podcast.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Extended Inflammatory Bowel Disease Knowledge (IBD-KNOW) Questionnaire
Tijdsspanne: Three months after enrollment (CONT group) or receiving the educational material (READ and HEAR groups).
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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).
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Likert Scale for Participant Satisfaction With Educational Content
Tijdsspanne: Three months after receiving the educational material (READ and HEAR groups).
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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).
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Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Follow-up
Tijdsspanne: Three months after receiving the educational material (READ and HEAR groups).
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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).
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Patient Health Questionnaire-9 (PHQ-9) Follow-up
Tijdsspanne: Three months after receiving the educational material (READ and HEAR groups).
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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).
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Disease activity Follow-up
Tijdsspanne: Three months after receiving the educational material (READ and HEAR groups).
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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).
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BM/21110-3/2023
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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