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.
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.
Process measures collected by coaches will include Goal Attainment,
Assessments will be conducted by telephone or Microsoft Teams, by trained Research
Assistants, or with the added option of being collected digitally for staff self-report
measures.
Data will also be collected on numbers of remote health and social care (HSC) consultations
and on unplanned hospital attendances/admissions (including fall-related injuries).
Researchers will also fully cost the COVID eWHELD intervention. To examine the opportunity
costs of the intervention, champions will be asked to identify activities that were not
undertaken in order to participate and to report any paid and unpaid overtime related to time
spent in the champion role. Unit costs will be obtained from nationally applicable sources
(PSSRU UC, NHS Reference costs) or calculated anew where necessary.
Key elements of the WHELD intervention include:
- Coaching/training to deliver the WHELD programme which includes person-centred care and
person-centred activities and person-centred care plans.
- A COVID-19 specific resource toolkit - digital bite-sized practical content to stay
connected, develop new routines, how to respond to virus-related fear and anxiety
- Facilitated online peer support network for care home managers to share stories and
solutions for COVID-19 challenges
- Pooling insights from others to create short, digestible digital resources, such as:
checklists, video tips, one-page guides, do's and don'ts, infographics, etc.
- Providing communal, collaborative online group supervision calls, to promote staff
well-being and peer-to-peer communities in an online gathering place
- Developing easy reference guides to enable staff to support residents, where appropriate,
to use virtual communication tools to stay connected with family and friends
- Providing a series of suggestions, activities, and games all designed to foster
connection during a time of isolation
As the intervention is optimized best practice, the researchers would consider this activity
as service delivery and not research. The research element is the evaluation of potential
benefits for residents and staff, and the evaluation of cost-effectiveness.
Analyses and reporting will follow CONSORT guidance. A full statical analysis plan will be
developed during the initial phases of the project and signed off prior to database lock.
The UK Clinical Research Collaboration (UKCRC)-registered Exeter Clinical Trials Unit will be
fully involved in the design, management and governance of the RCT aspects of the trial. The
unit will have input into the methodology, provide central trial management/senior oversight,
build and test the required data collection systems, undertake randomization, manage the data
and ensure a surrounding quality assurance framework.
Care homes will specifically be able to pause participation in the study if there is a
COVID-19 outbreak in the care home.
Other: COVID WHELD
COVID WHELD is a COVID-19 adapted version of an established nursing home training intervention that confers benefits in well-being and neuropsychiatric symptoms for people with dementia. The adaptations include the development of digital resources to support the programme and virtual coaching.
Inclusion Criteria:
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.
Exclusion Criteria:
Care homes under special measures with the local authority
Residents from whom consent or the advice of a consultee cannot be obtained.
University of Exeter
Exeter, Devon, UK, United Kingdom
Clive G Ballard, MD
00441392 72 2805
c.ballard@exeter.ac.uk
Dag Aarsland, MD
44 20 7848 0508
dag.aarsland@kcl.ac.uk
Clive Ballard, MD, Principal Investigator
The University of Exeter