University of Rome Tor Vergata, Roma, Italy
University of Rome Tor Vergata, Roma, Italy.
BMJ Open Gastroenterol. 2024 Aug 29;11(1):e001510. doi: 10.1136/bmjgast-2024-001510.
Supporting patient self-care and the contribution of their caregivers is crucial in chronic illness care. Inflammatory bowel disease (IBD) is a chronic condition whose prevalence is expected to double, especially in Western countries. IBD symptoms can negatively impact patients' well-being, causing high anxiety, depression, stress and reduced quality of life. These symptoms also affect the health of family members and friends, who often take on caregiving roles during exacerbations. Knowledge about self-care in IBD (IBD-SELF) is limited, and few studies have explored this context. This paper outlines a research protocol for a multicentre longitudinal study to investigate patient self-care and caregiver contributions to IBD-SELF.
A sample of 250 consecutive patients diagnosed with IBD and their caregivers will be recruited from 9 dedicated IBD units in northern, central and southern Italy during outpatient visits. Data collection will occur at baseline, 6 and 12 months after enrolment. Multivariable regressions, path analyses and structural equation models will identify predictors (eg, health literacy, caregiver burden and depression) and outcomes (use of healthcare services, disease severity and quality of life) of self-care and caregiver contributions. Dyadic analyses will control for the interdependence of dyad members.
Ethical approval was obtained from the Territorial Ethics Committee (Lazio 3) N. 0023486/23 and registered on ClinicalTrials.gov (Identifier number: NCT06015789). This study will enhance our understanding of the self-care process in the patient-caregiver dyad in IBD, aiding the design of future educational interventions and promoting greater patient and caregiver involvement in the care pathway.
ClinicalTrials.gov: NCT06015789.
在慢性病护理中，支持患者的自我护理和其照顾者的贡献至关重要。炎症性肠病（IBD）是一种慢性疾病，其发病率预计将翻一番，尤其是在西方国家。IBD 症状会对患者的幸福感产生负面影响，导致高度焦虑、抑郁、压力和生活质量下降。这些症状还会影响家庭成员和朋友的健康，他们在病情加重时经常承担照顾者的角色。IBD 自我护理（IBD-SELF）的知识有限，很少有研究探讨这方面的内容。本文概述了一项多中心纵向研究的研究方案，旨在调查患者的自我护理和照顾者对 IBD-SELF 的贡献。
将从意大利北部、中部和南部的 9 个专门的 IBD 单位在门诊就诊时招募 250 名连续确诊为 IBD 的患者及其照顾者作为样本。数据收集将在基线、入组后 6 个月和 12 个月进行。多变量回归、路径分析和结构方程模型将确定自我护理和照顾者贡献的预测因素（例如健康素养、照顾者负担和抑郁）和结果（医疗服务的使用、疾病严重程度和生活质量）。对二元分析将控制对二元成员的相互依存关系。
伦理批准已获得领土伦理委员会（拉齐奥 3 号）N. 0023486/23，并在 ClinicalTrials.gov 上注册（标识符编号：NCT06015789）。这项研究将增强我们对 IBD 中患者-照顾者二元体自我护理过程的理解，有助于设计未来的教育干预措施，并促进患者和照顾者更多地参与护理途径。
ClinicalTrials.gov：NCT06015789。
