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