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Nationwide Survey of Telemedicinal Patient Education in IBD

2026년 6월 29일 업데이트: 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

연구 개요

연구 유형

중재적

등록 (실제)

432

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Szeged, 헝가리, 6725
        • University Of Szeged

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • IBD patients
  • age ≥18 years

Exclusion Criteria:

  • withdrawing consent

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: CONT (Control)
The group not receiving any educational content.
실험적: READ (Written PDF Document)
The group receiving the educational content in the form of a 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.
실험적: HEAR (Audio Podcast)
The group receiving the educational content in the form of an 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Extended Inflammatory Bowel Disease Knowledge (IBD-KNOW) Questionnaire
기간: 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).

2차 결과 측정

결과 측정
측정값 설명
기간
Likert Scale for Participant Satisfaction With Educational Content
기간: 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
기간: 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
기간: 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
기간: 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).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 10월 1일

기본 완료 (실제)

2025년 12월 31일

연구 완료 (실제)

2025년 12월 31일

연구 등록 날짜

최초 제출

2026년 5월 21일

QC 기준을 충족하는 최초 제출

2026년 6월 29일

처음 게시됨 (실제)

2026년 6월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 29일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • BM/21110-3/2023

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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