Allan Louise M, Wheatley Alison, Flynn Elizabeth, Smith Amy, Fox Chris, Howel Denise, Barber Robert, Homer Tara Marie, Robinson Louise, Parry Steve Wayne, Corner Lynne, Connolly Jim Anthony, Rochester Lynn, Bamford Claire
1Institute of Health Research, University of Exeter, South Cloisters, St Luke's Campus, Heavitree Road, Exeter, EX1 2LU UK.
2Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
Pilot Feasibility Stud. 2018 Nov 10;4:170. doi: 10.1186/s40814-018-0364-7. eCollection 2018.
People with dementia (PWD) experience ten times as many incident falls as people without dementia. Little is known about how best to deliver services to people with dementia following a fall. We used an integrated, mixed-methods approach to develop a new intervention which combines theory generated via a realist synthesis and data on current provision and pathways, gathered through a prospective observational study as well as qualitative interviews, focus groups and ethnographic observation. This intervention is to be tested in a feasibility study in the UK National Health Service.
People living with dementia in one of three geographical areas will be eligible for the study if they experience a fall requiring healthcare attention and have an informal carer. Potential participants will be identified by community services (primary care, paramedics, telecare), secondary care (ED, facilitated discharge services, rehabilitation outreach teams) and research case registers. Participants will receive a complex multidisciplinary intervention focused on their goals and interests for up to 12 weeks. The intervention will be delivered by occupational therapists, physiotherapists and rehabilitation support workers. Feasibility outcomes will include recruitment and retention, suitability and acceptability of outcome measures and acceptability, feasibility and fidelity of intervention components. PWD outcome measures will include number of falls, Montreal Cognitive Assessment (MOCA), European Quality of Life Instrument (EQ-5D-5L), Quality of Life-Alzheimer's Disease Scale (QOL-AD), Modified Falls Efficacy Scale (MFES) and Goal Attainment Scaling (GAS). PWD outcome measures completed by an informal carer will include Disability Assessment for Dementia (DAD), EQ-5D-5L Proxy, QoL-AD Proxy and a Health Utilisation Questionnaire (HUQ). The carer outcome measure will be the Zarit Burden Interview (ZBI). An embedded process evaluation will explore barriers and facilitators to recruitment and intervention delivery.
The study results will inform whether and how a larger multicentre RCT should be undertaken. A full RCT would have the potential to show how outcomes can be improved for people with dementia who have fallen.
The National Research Ethics Service Committee Newcastle and North Tyneside 2 approved the feasibility study.
International Standard Randomised Controlled Trial Registry. Registration number: ISRCTN41760734. Date of registration: 16/11/2015.
痴呆症患者（PWD）发生跌倒的几率是无痴呆症患者的十倍。对于跌倒后如何最好地为痴呆症患者提供服务，我们知之甚少。我们采用了一种综合的混合方法来开发一种新的干预措施，该措施结合了通过现实主义综合产生的理论以及通过前瞻性观察研究以及定性访谈、焦点小组和人种学观察收集的有关当前服务提供和途径的数据。这种干预措施将在英国国家医疗服务体系的一项可行性研究中进行测试。
居住在三个地理区域之一的痴呆症患者如果经历了需要医疗护理的跌倒且有非正式护理人员，将有资格参加该研究。潜在参与者将由社区服务机构（初级保健、护理人员、远程护理）、二级护理机构（急诊科、便利出院服务、康复外展团队）和研究病例登记册确定。参与者将接受一项为期长达12周、以其目标和兴趣为重点的复杂多学科干预。该干预将由职业治疗师、物理治疗师和康复支持人员提供。可行性结果将包括招募和保留情况、结果测量的适用性和可接受性以及干预组成部分的可接受性、可行性和保真度。痴呆症患者的结果测量将包括跌倒次数、蒙特利尔认知评估（MOCA）、欧洲生活质量量表（EQ-5D-5L）、阿尔茨海默病生活质量量表（QOL-AD）、改良跌倒效能量表（MFES）和目标达成量表（GAS）。由非正式护理人员完成的痴呆症患者结果测量将包括痴呆症残疾评估（DAD）、EQ-5D-5L代理量表、QoL-AD代理量表和健康利用问卷（HUQ）。护理人员的结果测量将是扎里特负担访谈（ZBI）。一项嵌入式过程评估将探索招募和干预实施的障碍和促进因素。
研究结果将为是否以及如何开展更大规模的多中心随机对照试验提供信息。一项全面的随机对照试验有可能表明如何改善跌倒的痴呆症患者的结局。
国家研究伦理服务委员会纽卡斯尔和北泰恩赛德2批准了该可行性研究。
国际标准随机对照试验注册库。注册号：ISRCTN41760734。注册日期：2015年11月16日。
