跳至主要内容
临床试验/NCT07020481
NCT07020481尚未招募不适用

Spiritual Needs of Patients With Inflammatory Bowel Disease and Their Caregivers: a European Cross-sectional Nursing Study

University of Padova0 个研究点目标入组 1,000 人开始时间: 2025年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
主要终点
Spiritual Needs Questionnaire (SpNQ-EV)

研究概览

简要总结

A European-wide cross-sectional non-interventional study, initiated by a pilot study in Italy, will be conducted. The first phase of the pilot study is a 6-step translation, adaptation, and validation of the extended version of the Spiritual Needs Questionnaire (SpNQ-EV) and the Interpretation of Illness Questionnaire (IIQ) adopting the methodology [3] described in figure 1. To ensure they are both valid and user-friendly, the Thinking Out Loud (TOL) technique (think-aloud method) will pre-test their self-administration and provide fine tuning of the secondary objectives of the study. TOL involves participants verbalizing their thoughts while completing the questionnaires, allowing to capture real-time insights into their understanding, interpretation, and potential challenges with questionnaires' items. The second phase will consist of an anonymous e-survey consisting of the six questionnaires described in table 1 including the translated and validated SPNQ-EV and IIQ developed in phase 1. The European study will employ a multilingual anonymous e-survey developed to ensure accessibility in participants' native languages, eventually preceded by country-based pilot studies. Eligible participants include adolescents and adults with IBD, as well as their caregivers, recruited via nurses and patient associations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •adolescents and adults of all ages clinically diagnosed with CD, UC, or any other form of IBD (such as indeterminate colitis or IBD unclassified).

排除标准

  • 未提供

结局指标

主要结局

Spiritual Needs Questionnaire (SpNQ-EV)

时间窗: Day 1 (From enrollment to the end of data collection (end of questionnaire completion) - same day

To assess the spiritual needs among European IBD patients and their caregivers

次要结局

未报告次要终点

研究者

发起方
University of Padova
申办方类型
Other
责任方
Sponsor

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