LIVE@Home.Path: a Mixed Method, Stepped Wedge and Randomized Controlled Trial Innovating the Clinical Pathway for Home-dwelling Persons With Dementia and Their Families
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Resource Utilization in Dementia
研究概览
简要总结
This study aims at developing, implementing and evaluating a complex intervention involving Learning, Innovation, Volunteers and Empowerment for home dwelling persons with dementia and their caregivers. The investigators hypothesise that a successfully implemented intervention will reduce caregivers burden and be cost-effective.
详细描述
The provision of economically viable and proper care for the growing group of home-dwelling people with dementia (PWD) is one of the most pressing issues in our society. While a cure for dementia is not yet available, professionals and policy-makers highly prioritize the support of caregivers who experience a vast burden. However, there is a lack of high-quality research investigating clinical, social and economic factors that may add beneficial effects. This project aims to develop, test, and implement a complex intervention for PWD, intended to reduce caregivers' burden, which will aid PWD to stay safely, longer and independently at home with dignity and cost-effectiveness. The term informal caregivers' burden may include different meanings for different people and be related to economic burden, depression and anxiety, quality of life (QoL), or simply the quality of sleep and recreation. In a stepped wedge, cluster randomized controlled trial, involving primary and secondary health care systems in Bergen, Bærum and Kristiansand the 24-month LIVE@Home.Path study will be undertaken in a stepped wedge design. The user-inspired and tailored intervention includes a designated coordinator to the PWD and caregiver for 6 months to introduce a complex intervention involving a) Learning b) Innovation c) Volunteers and d) Empowerment.
Qualitative interviews will determine users' values and wishes, and promotors and barriers for successful implementation of the intervention. Primary and secondary outcomes on cognitive, emotional and social factors, cost-benefit analyses, and QoL of PWD and families will be assessed every 6-month over 2 years.
Update spring 2020: The COVID-19 pandemic severely hampered the implementation of the intervention for the second group. We therefore had to change the design, postponing the intervention in Bærum and Kristiansand, and delivering the intervention in Bergen by phone. In addition, we initiated the PAN.DEM in the LIVE@Home.Path trial, collecting data from phone interviews with caregivers on change in Health services and neuropsychiatric symptoms, risk perception and restrictions. Changes in design approved by Ethical committee (REK: 10861).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Home-dwelling people with dementia (PWD) equal or above 65 years diagnosed according to national guidelines
- •Mini mental state examination score 15-24
- •Functional Assessment Staging Test (FAST score 4-7)
- •Living with a partner, or have regular contact with a caregiver minimum 1 hour/week
排除标准
- •Participate in other trials
- •Expected survival under 4 weeks
结局指标
主要结局
Resource Utilization in Dementia
时间窗: up to 24 months follow up, assesment every 6 months
RUD:A validated tool for assessment of time use for cost effectiveness analyses, measuring total time use in hours/day for different activities, numbers of contact points with care professionals and use of medications, high time use, many contacts and many medications indicates high resource use
Relative stress scale
时间窗: up to 24 months follow up, assessment every 6 months
RSS: measuring caregiver distress, 15 items ranging from 0-4, high score indicates high burden
次要结局
- Adverse events(24 months follow up, assesment every 6 months)
- Comorbidity(24 months follow up, assesment every 6 months)
- Medication use(At the start of the intervention, and every 6 onth follow up)
- Participation in educational programs(24 months follow up, assessment every 6 months)
- Activities of daily living, instrumental(24 months follow up, assesment every 6 months)
- Depression and mood(24 months follow up, assesment every 6 months)
- Activities of daily living, personal(24 months follow up, assesment every 6 months)
- Quality of Life VAS scale(24 months follow up, assesment every 6 months)
- Caregiver depression(24 months follow up, assesment every 6 months)
- Change in cognitive performance(Baseline)
- Agitation(24 months follow up, assesment every 6 months)
- Use of assistive technology(24 months follow up, assesment every 6 months)
- Neuropsychiatric symptoms(24 months follow up, assesment every 6 months)
- Change achieving(at the start of intervention, and every 6 months)
- Pain in dementia(24 months follow up, assesment every 6 months)
- Use of volunteers(24 months follow up, assesment every 6 months)
- Quality of Life(24 months follow up, assesment every 6 months)