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临床试验/NCT07675369
NCT07675369已完成不适用

Nationwide Survey of Telemedicinal Patient Education in IBD - Baseline Knowledge Gaps and a Randomized Comparison of Podcast Versus Written Format

Szeged University1 个研究点 分布在 1 个国家目标入组 432 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
432
试验地点
1
主要终点
Extended Inflammatory Bowel Disease Knowledge (IBD-KNOW) Questionnaire

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • IBD patients
  • age ≥18 years

排除标准

  • withdrawing consent

结局指标

主要结局

Extended Inflammatory Bowel Disease Knowledge (IBD-KNOW) Questionnaire

时间窗: 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.

次要结局

  • 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).)

研究者

发起方
Szeged University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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