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SC-IBD自我护理测量量表的开发 (SC-IBD)

2026年9月18日 更新者：Fondazione Policlinico Universitario Agostino Gemelli IRCCS

炎症性肠病（IBD）患者自我护理测量量表的开发及其在门诊环境中的应用

This study aims to develop and validate a disease-specific self-care measurement scale for patients with Inflammatory Bowel Disease (IBD). The research follows a sequential mixed-methods design: a qualitative phase to identify key self-care concepts, followed by a quantitative phase to test the psychometric properties of the newly developed SC-IBD scale in an outpatient population.

研究概览

地位

尚未招聘

条件

详细说明

This study is designed to develop and validate the SC-IBD scale, a disease-specific instrument for measuring self-care in patients with Inflammatory Bowel Disease (IBD). The project uses a sequential exploratory mixed-methods design.

In the qualitative phase, semi-structured interviews will be conducted with outpatients diagnosed with IBD to explore their experiences of self-care across the three theoretical dimensions described in the Middle-Range Theory of Self-Care of Chronic Illness: maintenance, monitoring, and management. The qualitative findings will inform item generation and content validity assessment through a multidisciplinary expert panel.

The quantitative phase will include the administration of the preliminary SC-IBD scale to an outpatient cohort in order to evaluate its psychometric properties, including construct validity, internal consistency, and test-retest reliability. Additional validated instruments (DASS-21, SF-12, BIPQ, IBD-Control, and the Short Food Literacy Questionnaire) will be used to assess convergent and divergent validity and to describe relevant psychological, clinical and behavioral correlates of self-care in IBD.

The ultimate goal of the study is to produce a reliable, valid, and clinically useful tool for assessing self-care behaviors in individuals living with IBD, supporting both research and clinical practice.

研究类型

观察性的

注册 (估计的)

275

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 意大利
    • RM
      • Roma、RM、意大利、00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
        • 接触：
        • 首席研究员：
          • Daniele Napolitano, RN

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population consists of adult outpatients diagnosed with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) followed at the IBD outpatient clinic of the Fondazione Policlinico Universitario A. Gemelli IRCCS and affiliated satellite centers. Participants must have received an IBD diagnosis for at least 12 months, be able to read and speak Italian, and be willing to participate in either the qualitative or quantitative phase of the study. A total of 275 patients will be enrolled.

描述

Inclusion Criteria:

  • Voluntary willingness to participate in the study.
  • Diagnosis of Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) for at least 12 months.
  • Follow-up in outpatient setting.
  • Age 18 years or older.
  • Ability to read and speak Italian.
  • Ability to understand the study procedures.
  • Signed informed consent.

Exclusion Criteria:

  • Age younger than 18 years.
  • Significant cognitive impairment (e.g., dementia) that may limit participation.
  • Insufficient comprehension of the Italian language.
  • Severe psychiatric disorders that may compromise participation.
  • Severe clinical conditions preventing participation in interviews or questionnaire completion.
  • Refusal to sign the informed consent form.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Psychometric Validation of the SC-IBD Scale
大体时间：Baseline to 3 months

Assessment of the psychometric properties of the SC-IBD scale, including internal consistency (e.g., McDonald's Omega), construct validity (exploratory and confirmatory factor analyses), content validity, convergent and divergent validity, and test-retest reliability. Analyses will determine whether the scale reliably and validly measures self-care behaviors in patients with Inflammatory Bowel Disease.
Baseline to 3 months

次要结果测量

结果测量
措施说明
大体时间
Qualitative Themes of Self-Care in Patients with IBD
大体时间：Baseline

Qualitative analysis of semi-structured interviews to identify recurring themes and patterns of self-care behaviors across the dimensions of self-care maintenance, monitoring, and management, based on the Middle-Range Theory of Self-Care of Chronic Illness. Findings inform the generation and refinement of SC-IBD scale items.
Baseline
Psychological Distress Measured by DASS-21
大体时间：Baseline

Assessment of depression, anxiety, and stress using the DASS-21 validated Italian version. Scores will be used to evaluate convergent and divergent validity of the SC-IBD scale and explore associations between self-care and psychological distress.
Baseline
Health-Related Quality of Life Assessed by SF-12
大体时间：Baseline

Measurement of physical and mental health components through the SF-12 questionnaire to evaluate relationships between self-care behaviors and quality of life, supporting the SC-IBD validity analysis.
Baseline
Illness Perception Measured by BIPQ
大体时间：Baseline

Evaluation of cognitive and emotional representations of illness using the Brief Illness Perception Questionnaire. Correlations with the SC-IBD scale will be used to assess construct validity.
Baseline
Perceived Disease Control Measured by IBD-Control
大体时间：Baseline

Assessment of patient-reported control of IBD using the validated Italian version of the IBD-Control questionnaire (extended form with VAS). Used to explore relationships between perceived disease control and self-care behaviors.
Baseline
Food Literacy Assessed by the Short Food Literacy Questionnaire
大体时间：Baseline

Measurement of food literacy using the SFLQ (Italian version). Results will help determine whether food literacy acts as a determinant or moderator of self-care in patients with IBD and evaluate convergent validity of the SC-IBD scale.
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

调查人员

  • 首席研究员：Daniele Napolitano, RN、Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月30日

初级完成 (估计的)

2027年10月30日

研究完成 (估计的)

2028年10月30日

研究注册日期

首次提交

2026年3月20日

首先提交符合 QC 标准的

2026年3月20日

首次发布 (实际的)

2026年3月27日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月18日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 8158 - SC-IBD

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

No, there is no plan to share individual participant data (IPD). Data will remain stored in pseudonymized form within the institution according to GDPR and local ethical requirements.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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