NCT04590469: COVIDWHELD

Improving Wellbeing and Health for Care Home Residents During COVID-19

Withdrawn NA Last updated 22 May 2024

What this trial tests

NA trial testing COVID WHELD in Dementia. Withdrawn.

Timeline

1 March 2021

Primary endpoint
1 December 2021

1 January 2022

Quick facts

Lead sponsor	University of Exeter
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Start date	1 March 2021
Primary completion	1 December 2021
Estimated completion	1 January 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• COVID WHELD

Conditions studied

• Dementia — all drugs for Dementia →

Sponsor

University of Exeter

Who can join

60 and older, any sex, with Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of the Covid-19 pandemic on neuropsychiatric symptoms and antipsychotic prescribing for people with dementia in nursing home settings.
   McDermid J, Ballard C, Khan Z, Aarsland D, et al · · 2023 · cited 21× · PMID 36704984 · DOI 10.1002/gps.5878
2. Impact of the iWHELD digital person-centered care program on quality of life, agitation and psychotropic medications in people with dementia living in nursing homes during the COVID-19 pandemic: A randomized controlled trial.
   McDermid J, Henley W, Corbett A, Williams G, et al · · 2024 · cited 6× · PMID 38116916 · DOI 10.1002/alz.13582