Evidence-Based Supported Digital Intervention for Improving Wellbeing and Health of People Living in Care Homes and Care Home Staff (WHELD) During COVID-19: An RCT to Evaluate COVID-19 Adapted E-WHELD: Benefits and Cost-Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Dementia Quality of Life - DEMQOL proxy
研究概览
简要总结
More than 400,000 people in the UK live in care homes. These individuals are particularly vulnerable to COVID-19; many are frail and the majority have concurrent physical health problems and dementia. This group are at the highest risk of becoming severely ill with COVID-19 and are dependent on a stretched care workforce. The isolation, together with the stresses and distressing nature of the current work environment is also likely to have an impact on the mental health and well-being of care staff. It is vital to provide good quality support to enable care staff to remain resilient, and to enable good quality care that maintains the well-being of residents with dementia and reduces emerging neuropsychiatric symptoms in residents without increasing harmful sedative medications.
COVID E-WHELD is based on the optimized WHELD training intervention on successfully completed in randomised clinical trials (RCTs) in 86 care homes, more than 1000 people with dementia. WHELD reduced use of anti-psychotics, improved agitation and overall neuropsychiatric symptoms, improved quality of life and reduced mortality for people with dementia. A digital version of WHELD (eWHELD) with virtual supervision in a further care home RCT including 130 people with dementia has demonstrated benefits for staff carers and improvements in the quality of life of people with dementia, with eWHELD combined with virtual supervision, but not with e-learning alone.
The current project will evaluate a COVID-19 adapted version of eWHELD to address current needs of care homes during the COVID-19 pandemic. This will be undertaken in a 2 arm, 4 month, randomized cluster RCT in 1280 care homes (allowing for 75% drop out with COVID-19 outbreaks) to determine whether COVID-19 adapted eWHELD improves quality of life and mental health for people with dementia in care homes and the mental health of care staff.
详细描述
COVID E-WHELD: Effectiveness and Cost-Effectiveness
COVID-19 adapted WHELD (with digital resources and virtual coaching) will be compared to usual care in a 4 month randomized, parallel group, cluster RCT with 1280 care homes (allowing for 75% drop out because of COVID-19 outbreaks). Care homes will be randomly assigned to WHELD or treatment as usual in a 1:1 ratio. All care homes receiving treatment as usual will be offered the WHELD intervention after 4 months.
Recruitment will build upon a number of networks and contacts. The investigators already have a network of more than 1300 care homes who would be our first point of contact (100 additional care homes from Biomedical Research Centre (BRC) care home network. The investigators have a long established and successful record of recruiting large numbers of care homes to clinical trials (WHELD programme, FITS programme, Pimavanserin programme which involved more than 160 care homes).
Evaluation will be undertaken at baseline, 4 weeks and 4 months post-baseline.
The primary outcome measure will be quality of life in care home residents at 4 months, measured by the DEMQOL proxy, which has shown significant benefits in previous WHELD RCTs. The secondary outcomes will include cost-effectiveness (EQ-5D), health utilization, use of sedative medications (anti psychotics, hypnotics), neuropsychiatric symptoms, staff confidence (CODE), staff self-efficacy (SCIDS) and staff mental health (PHQ9) and a COVID-19 tracker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The intervention is a care home/nursing home training programme/coaching and a digital platform. The research assistants collecting data will do so using virtual platforms and will not be told the randomization of participating care homes. Participating care homes will be told not to disclose treatment allocation, and this will be reinforced by the research assistant at the start of each research assessment to maintain the blind.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Care homes which include people with dementia within their client group
- •All individuals residing in participating care homes who meet diagnostic criteria for dementia and/or score '1' or greater on the Clinical Dementia Rating Scale.
排除标准
- •Care homes under special measures with the local authority
- •Residents from whom consent or the advice of a consultee cannot be obtained.
结局指标
主要结局
Dementia Quality of Life - DEMQOL proxy
时间窗: 4 months
Validated quality of life measure for people with dementia, assessed by informant interview. Minimum score = 32 Maximum score = 128; Higher score denotes better outcome.
次要结局
- Patient Health Questionnaire (PHQ-9)(4 months)
- EQ5D (Euroquol 5D - 5 dimensions)(4 months)
- Psychotropic medications(4 months)
- Client Service Receipt Inventory(4 months)
- Confidence in Dementia (CODE) Scale(4 months)
- Sense of Competence in Dementia Care Staff (SCIDS) scale(4 months)
- Neuropsychiatric Inventory(4 months)