Carey Mariko L, Kelly Michelle, Pond Dimity, Nair Balakrishnan R, Attia John, Jeon Yun-Hee, Deeming Simon, Rhee Joel J, Wales Kylie, Khaing Kay, Williams Anna, White Jennifer, Harden Mandy, Ford Claudine, Ward John, Lithgow Stephanie, Oldmeadow Christopher, Jalewa Jaishree, Smart Emma, Wood Kate, Bartczak Amelia, Fakes Kristy
School of Medicine and Public Health, College of Health Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia
Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.
BMJ Open. 2025 Apr 15;15(4):e095473. doi: 10.1136/bmjopen-2024-095473.
The multifaceted impact of dementia means that people living with dementia require multidisciplinary care across different services and settings; however, these care transitions pose a risk of fragmented care. Models that improve integration and coordination of care in the community are needed.
This randomised control trial will test the effectiveness and cost effectiveness of a dementia nurse-led intervention to: (1) increase days lived in the community at 12-month follow-up (primary outcome) among people living with dementia and (2) improve quality of life for people living with dementia and their carers, compared with usual care. Participants are recruited from several sources including private and public geriatric medicine clinics, carer support groups and self-referral. People living with dementia and their carers are randomised as a dyad to (1) usual care or (2) dementia nurse-led care-coordination. The dementia nurse will provide care coordination and direct support through a tailored, integrated and patient-centred approach. The needs of people living with dementia will be identified and addressed, with a focus on improving the management of comorbidities, risk reduction and symptoms. Carers will also receive support. The model for people living with dementia will focus on days lived in their community as the outcome variable. Differences between groups in quality of life at 12-month follow-up will be assessed using linear mixed effects regression. Analysis will follow the intention to treat principles. People living with dementia and carers' data will be analysed separately and collectively for the economic study.
The trial has been approved by the Hunter New England Research Ethics Committee (2023/ETH01221) and the University of Newcastle Ethics Committee (R-2024-0021). Trial findings will be disseminated via peer-reviewed publications and conference presentations. If the intervention is effective, the research team aims to further implement the intervention as usual care within the participating services and beyond.
The trial was prospectively registered via the Australian New Zealand Clinical Trials Registry: ACTRN12624000235505. Registration date: 11 March 2024.
痴呆症具有多方面的影响,这意味着痴呆症患者需要在不同服务和环境中接受多学科护理;然而,这些护理过渡存在护理碎片化的风险。因此需要能够改善社区护理整合与协调的模式。
这项随机对照试验将测试由痴呆症护士主导的干预措施的有效性和成本效益,以:(1)在12个月随访时增加痴呆症患者在社区生活的天数(主要结局),以及(2)与常规护理相比,改善痴呆症患者及其护理者的生活质量。参与者从多个来源招募,包括私立和公立老年医学诊所、护理者支持小组以及自我推荐。痴呆症患者及其护理者作为二元组被随机分配到:(1)常规护理或(2)由痴呆症护士主导的护理协调。痴呆症护士将通过量身定制、综合且以患者为中心的方法提供护理协调和直接支持。将识别并满足痴呆症患者的需求,重点是改善合并症管理、降低风险和缓解症状。护理者也将获得支持。针对痴呆症患者的模式将把在社区生活的天数作为结局变量。将使用线性混合效应回归评估12个月随访时两组在生活质量方面的差异。分析将遵循意向性分析原则。痴呆症患者和护理者的数据将分别进行分析,并共同用于经济学研究。
该试验已获得亨特新英格兰研究伦理委员会(2023/ETH01221)和纽卡斯尔大学伦理委员会(R - 2024 - 0021)的批准。试验结果将通过同行评审出版物和会议报告进行传播。如果干预措施有效,研究团队旨在进一步在参与服务机构及其他机构中将该干预措施作为常规护理实施。
该试验已通过澳大利亚新西兰临床试验注册中心进行前瞻性注册:ACTRN12624000235505。注册日期:2024年3月11日。