Center of Clinical Reaerch in Dalarna, Falun, Sweden.
Department of Medical Sciences, Uppsala Universitet Medicinska fakulteten, Uppsala, Sweden.
BMJ Open. 2018 Oct 17;8(10):e023064. doi: 10.1136/bmjopen-2018-023064.
Liver cirrhosis affects health-related quality of life (HRQoL) even in its early stages. Morbidity is especially high when the disease decompensates and self-care actions become essential. Nurse involvement in secondary prevention in other chronic diseases has contributed to better symptom control, less need of inpatient care and improved HRQoL. In order to evaluate the impact of nurse involvement in the follow-up of patients with liver cirrhosis, we decided to compare structured nurse-led clinics, inspired by Dorothea Orem's nursing theory and motivational strategies, with a group of patients receiving standard care. The primary outcome is HRQoL and the secondary outcomes are quality of care, visits to outpatient clinics or hospitals, disease progress and health literacy.
This is a pragmatic, multicentre randomised controlled study conducted at six Swedish hepatology departments. Eligible patients are adults with diagnosed cirrhosis of the liver (n=500). Participants are randomised into either an intervention with nurse-led follow-up group or into a standard of care group. Recruitment started in November 2016 and is expected to proceed until 2020. Primary outcomes are physical and mental HRQoL measured by RAND-36 at enrolment, after 1 and 2 years.
The study is ethically approved by the Regional Ethical Review Board in Uppsala. The results shall be disseminated in international conferences and peer-reviewed articles.
NCT02957253; Pre-results.
肝硬化即使在早期阶段也会影响健康相关生活质量（HRQoL）。当疾病失代偿且自我护理行动变得至关重要时，发病率尤其高。护士参与其他慢性疾病的二级预防有助于更好地控制症状、减少住院需求和改善 HRQoL。为了评估护士参与肝硬化患者随访对患者的影响，我们决定将受 Dorothea Orem 的护理理论和动机策略启发的结构化护士主导的诊所与接受标准护理的患者组进行比较。主要结果是 HRQoL，次要结果是护理质量、门诊或住院就诊次数、疾病进展和健康素养。
这是一项在瑞典六个肝病科进行的实用、多中心随机对照研究。合格的患者是诊断为肝硬化的成年人（n=500）。参与者随机分为护士主导的随访组或标准护理组。招募工作于 2016 年 11 月开始，预计将持续到 2020 年。主要结局是 RAND-36 在入组时、1 年后和 2 年后测量的身体和心理 HRQoL。
该研究已获得乌普萨拉地区伦理审查委员会的伦理批准。研究结果将在国际会议和同行评审的文章中公布。
NCT02957253；预结果。
