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

NCT04590469 | Withdrawn DMC

• 1 other identifier: 20-21-10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• Dementia Quality of Life - DEMQOL proxy

  Validated quality of life measure for people with dementia, assessed by informant interview. Minimum score = 32 Maximum score = 128; Higher score denotes better outcome.

  4 months

Secondary Outcomes (7)

• Neuropsychiatric Inventory

  4 months

• Psychotropic medications

  4 months

• Confidence in Dementia (CODE) Scale

  4 months

• Sense of Competence in Dementia Care Staff (SCIDS) scale

  4 months

• Patient Health Questionnaire (PHQ-9)

  4 months

Other Outcomes (1)

• Goal Attainment Scaling

  4 months

Study Arms (2)

WHELD training/virtual coaching programme supported with digital resources

EXPERIMENTAL

WHELD training/virtual coaching programme supported with digital resources

Other: COVID WHELD

Treatment as Usual

NO INTERVENTION

Usual Best practice

Interventions

COVID WHELD OTHER

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.

WHELD training/virtual coaching programme supported with digital resources

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Care homes under special measures with the local authority
• Residents from whom consent or the advice of a consultee cannot be obtained.

Sponsors & Collaborators

• University of Exeter: lead
• King's College London: collaborator
• London School of Economics and Political Science: collaborator
• University of East Anglia: collaborator
• University of Hull: collaborator
• Alzheimer's Society: collaborator

Study Sites (1)

University of Exeter

Exeter, Devon, UK, EX1 2LU, United Kingdom

Location

Related Publications (11)

• Ballard C, Corbett A, Orrell M, Williams G, Moniz-Cook E, Romeo R, Woods B, Garrod L, Testad I, Woodward-Carlton B, Wenborn J, Knapp M, Fossey J. Impact of person-centred care training and person-centred activities on quality of life, agitation, and antipsychotic use in people with dementia living in nursing homes: A cluster-randomised controlled trial. PLoS Med. 2018 Feb 6;15(2):e1002500. doi: 10.1371/journal.pmed.1002500. eCollection 2018 Feb.

  PMID: 29408901 BACKGROUND

• Fossey J, Ballard C, Juszczak E, James I, Alder N, Jacoby R, Howard R. Effect of enhanced psychosocial care on antipsychotic use in nursing home residents with severe dementia: cluster randomised trial. BMJ. 2006 Apr 1;332(7544):756-61. doi: 10.1136/bmj.38782.575868.7C. Epub 2006 Mar 16.

  PMID: 16543297 BACKGROUND

• Brooker DJ, Latham I, Evans SC, Jacobson N, Perry W, Bray J, Ballard C, Fossey J, Pickett J. FITS into practice: translating research into practice in reducing the use of anti-psychotic medication for people with dementia living in care homes. Aging Ment Health. 2016 Jul;20(7):709-18. doi: 10.1080/13607863.2015.1063102. Epub 2015 Jul 13.

  PMID: 26167720 BACKGROUND

• Ballard C, Banister C, Khan Z, Cummings J, Demos G, Coate B, Youakim JM, Owen R, Stankovic S; ADP Investigators. Evaluation of the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer's disease psychosis: a phase 2, randomised, placebo-controlled, double-blind study. Lancet Neurol. 2018 Mar;17(3):213-222. doi: 10.1016/S1474-4422(18)30039-5.

  PMID: 29452684 BACKGROUND

• Smith SC, Lamping DL, Banerjee S, Harwood RH, Foley B, Smith P, Cook JC, Murray J, Prince M, Levin E, Mann A, Knapp M. Development of a new measure of health-related quality of life for people with dementia: DEMQOL. Psychol Med. 2007 May;37(5):737-46. doi: 10.1017/S0033291706009469. Epub 2006 Dec 19.

  PMID: 17176501 BACKGROUND

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

  PMID: 10109801 BACKGROUND

• Elvish R, Burrow S, Cawley R, Harney K, Pilling M, Gregory J, Keady J. 'Getting to Know Me': The second phase roll-out of a staff training programme for supporting people with dementia in general hospitals. Dementia (London). 2018 Jan;17(1):96-109. doi: 10.1177/1471301216634926. Epub 2016 Feb 27.

  PMID: 26924840 BACKGROUND

• Schepers AK, Orrell M, Shanahan N, Spector A. Sense of competence in dementia care staff (SCIDS) scale: development, reliability, and validity. Int Psychogeriatr. 2012 Jul;24(7):1153-62. doi: 10.1017/S104161021100247X. Epub 2012 Feb 20.

  PMID: 22340666 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Gordon JE, Powell C, Rockwood K. Goal attainment scaling as a measure of clinically important change in nursing-home patients. Age Ageing. 1999 May;28(3):275-81. doi: 10.1093/ageing/28.3.275.

  PMID: 10475864 BACKGROUND

• Ballard C, Orrell M, YongZhong S, Moniz-Cook E, Stafford J, Whittaker R, Woods B, Corbett A, Garrod L, Khan Z, Woodward-Carlton B, Wenborn J, Fossey J. Impact of Antipsychotic Review and Nonpharmacological Intervention on Antipsychotic Use, Neuropsychiatric Symptoms, and Mortality in People With Dementia Living in Nursing Homes: A Factorial Cluster-Randomized Controlled Trial by the Well-Being and Health for People With Dementia (WHELD) Program. Am J Psychiatry. 2016 Mar 1;173(3):252-62. doi: 10.1176/appi.ajp.2015.15010130. Epub 2015 Nov 20.

  PMID: 26585409 RESULT

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Clive Ballard, MD

  The University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4 month, randomized, parallel group cluster RCT comparing the WHELD nursing home programme with virtual coaching and digital support with treatment as usual

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: March 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

GB (1)