Clinical trial NCT04590469: Improving Wellbeing and Health for Care Home Residents During COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dementia
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: King's College London
name: London School of Economics and Political Science
name: University of East Anglia
name: University of Hull
name: Alzheimer's Society
First posted: 2020-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 month, randomized, parallel group cluster RCT comparing the WHELD nursing home programme with virtual coaching and digital support with treatment as usual
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dementia Quality of Life - DEMQOL proxy
timeFrame: 4 months
Secondary outcomes:
measure: Neuropsychiatric Inventory
timeFrame: 4 months
measure: Psychotropic medications
timeFrame: 4 months
measure: Confidence in Dementia (CODE) Scale
timeFrame: 4 months
measure: Sense of Competence in Dementia Care Staff (SCIDS) scale
timeFrame: 4 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 4 months
measure: EQ5D (Euroquol 5D - 5 dimensions)
timeFrame: 4 months
measure: Client Service Receipt Inventory
timeFrame: 4 months
Other outcomes:
measure: Goal Attainment Scaling
timeFrame: 4 months
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon, UK
Study officials:
affiliation: The University of Exeter
name: Clive Ballard, MD
role: PRINCIPAL_INVESTIGATOR
References:
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