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

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ClinicalTrials.gov Identifier: NCT04590469
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : May 28, 2021
Sponsor:
Collaborators:
King's College London
London School of Economics and Political Science
University of East Anglia
University of Hull
Alzheimer's Society
Information provided by (Responsible Party):
University of Exeter

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.


Condition or disease Intervention/treatment Phase
Dementia Other: COVID WHELD Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: WHELD training/virtual coaching programme supported with digital resources
WHELD training/virtual coaching programme supported with digital resources
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.

No Intervention: Treatment as Usual
Usual Best practice



Primary Outcome Measures :
  1. Dementia Quality of Life - DEMQOL proxy [ Time Frame: 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.


Secondary Outcome Measures :
  1. Neuropsychiatric Inventory [ Time Frame: 4 months ]
    Standardized assessment of neuropsychiatric symptoms in people with dementia, assessed by informant interview. Minimum score = 0 Maximum score = 144; Higher score denotes worse outcome.

  2. Psychotropic medications [ Time Frame: 4 months ]
    Use of antipsychotic and other psychotropic medications from prescribing charts

  3. Confidence in Dementia (CODE) Scale [ Time Frame: 4 months ]
    Staff confidence measure, self completed questionnaire. Minimum score = 9 Maximum score = 45; Higher score denotes better outcome.

  4. Sense of Competence in Dementia Care Staff (SCIDS) scale [ Time Frame: 4 months ]
    Perceived self efficacy of care staff, self completed questionnaire. Minimum score = 17 Maximum score = 68; Higher score denotes better outcome.

  5. Patient Health Questionnaire (PHQ-9) [ Time Frame: 4 months ]
    Mental Health of care staff, self reported questionnaire. Minimum score = 0 Maximum score = 27; Higher score denotes worse outcome.

  6. EQ5D (Euroquol 5D - 5 dimensions) [ Time Frame: 4 months ]
    A standardized instrument for measuring generic health related quality of life, used for Health economic evaluation. Visual Analogue scale minimum score = 0, maximum score = 100. Higher score denotes better outcome.

  7. Client Service Receipt Inventory [ Time Frame: 4 months ]
    to collect service utilization data for health economics. Assesses cost of service provision; as such no min/max values. Higher value denotes worse cost outcome.


Other Outcome Measures:
  1. Goal Attainment Scaling [ Time Frame: 4 months ]
    Ordinal scale to rate progress towards personalized goals for people with dementia as a process outcome. Scale for each goal: Minimum score = 1 Maximum score = 4; Higher score denotes better outcome.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590469


Contacts
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Contact: Clive G Ballard, MD 00441392 72 2805 c.ballard@exeter.ac.uk
Contact: Dag Aarsland, MD 44 20 7848 0508 dag.aarsland@kcl.ac.uk

Locations
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United Kingdom
University of Exeter Recruiting
Exeter, Devon, UK, United Kingdom, EX1 2LU
Sponsors and Collaborators
University of Exeter
King's College London
London School of Economics and Political Science
University of East Anglia
University of Hull
Alzheimer's Society
Investigators
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Principal Investigator: Clive Ballard, MD The University of Exeter
Publications of Results:
Other Publications:

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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT04590469    
Other Study ID Numbers: 20-21-10
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders