Department of Behavioural Science and Health, University College London, London, UK.
Division of Psychiatry, University College London, London, UK.
Trials. 2021 Dec 2;22(1):865. doi: 10.1186/s13063-021-05851-z.
Most people living with dementia want to remain living in their own homes and are supported to do so by family carers. No interventions have consistently demonstrated improvements to people with dementia's life quality, functioning, or other indices of living as well as possible with dementia. We have co-produced, with health and social care professionals and family carers of people with dementia, a new intervention (NIDUS-family). To our knowledge, NIDUS-family is the first manualised intervention that can be tailored to personal goals of people living with dementia and their families and is delivered by facilitators without clinical training. The intervention utilizes components of behavioural management, carer support, psychoeducation, communication and coping skills training, enablement, and environmental adaptations, with modules selected to address dyads' selected goals. We will evaluate the effect of NIDUS-family and usual care on goal attainment, as measured by Goal Attainment Scaling (GAS) rated by family carers, compared to usual care alone at 12-month follow-up. We will also determine whether NIDUS-family and usual care is more cost-effective than usual care alone over 12 months.
A randomised, two-arm, single-masked, multi-site clinical trial involving 297 people living with dementia-family carer dyads. Dyads will be randomised 2:1 to receive the NIDUS-family intervention with usual care (n = 199) or usual care alone (n = 98). The intervention group will be offered, over 1 year, via 6-8 video call or telephone sessions (or face to face if COVID-19 restrictions allow in the recruitment period) in the initial 6 months, followed by telephone follow-ups every 1-2 months to support implementation, with a trained facilitator.
Increasing the time lived at home by people living with dementia is likely to benefit lives now and in the future. Our intervention, which we adapted to include remote delivery prior to trial commencement due to the COVID-19 pandemic, aims to address barriers to living as well and as independently as possible that distress people living with dementia, exacerbate family carer(s) stress, negatively affect relationships, lead to safety risks, and frequently precipitate avoidable moves to a care home.
International Standard Randomised Controlled Trials Number ISRCTN11425138 . Registered on 7 October 2019.
大多数患有痴呆症的人都希望继续住在自己的家中，并得到家人的照顾。目前还没有干预措施能持续改善痴呆症患者的生活质量、功能或其他与痴呆症相关的生活指标。我们与医疗保健专业人员和痴呆症患者的家人共同制定了一项新的干预措施（NIDUS-family）。据我们所知，NIDUS-family 是第一个可以根据痴呆症患者及其家人的个人目标进行定制的、由未经临床培训的协调员提供的标准化干预措施。该干预措施利用行为管理、照顾者支持、心理教育、沟通和应对技能培训、赋权以及环境适应等组成部分，根据选定的目标模块来解决双方的目标。我们将通过照顾者对目标实现情况的评估（使用目标实现量表（GAS）进行评分），评估 NIDUS-family 干预与常规护理对目标实现的影响，与仅接受常规护理的情况进行比较，随访时间为 12 个月。我们还将确定在 12 个月内，NIDUS-family 干预与常规护理是否比仅接受常规护理更具成本效益。
一项涉及 297 名痴呆症患者-照顾者二人组的随机、两臂、单盲、多地点临床试验。二人组将按照 2:1 的比例随机分配接受 NIDUS-family 干预加常规护理（n=199）或仅接受常规护理（n=98）。干预组将在 1 年内接受 6-8 次视频通话或电话会议（如果在招募期间 COVID-19 限制允许，则进行面对面交流），在最初的 6 个月内进行，然后每隔 1-2 个月通过电话随访一次，以支持实施情况，并由一名经过培训的协调员进行。
增加痴呆症患者在家中居住的时间可能会使他们现在和未来的生活受益。我们的干预措施旨在解决可能导致痴呆症患者不适、加重照顾者压力、对关系产生负面影响、导致安全风险以及经常导致可避免地搬入养老院的与尽可能独立生活相关的障碍。我们根据 COVID-19 大流行期间预先开始试验的需要，对干预措施进行了调整，以包括远程交付。
国际标准随机对照试验编号 ISRCTN11425138。于 2019 年 10 月 7 日注册。
