Dementia Clinical Trial
— COVIDWHELDOfficial 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
NCT number | NCT04590469 |
Other study ID # | 20-21-10 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2021 |
Est. completion date | January 1, 2022 |
Verified date | May 2024 |
Source | University of Exeter |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 1, 2022 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Exeter | Exeter | Devon, UK |
Lead Sponsor | Collaborator |
---|---|
University of Exeter | Alzheimer's Society, King's College London, London School of Economics and Political Science, University of East Anglia, University of Hull |
United Kingdom,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Goal Attainment Scaling | 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. | 4 months | |
Primary | 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 | Neuropsychiatric Inventory | Standardized assessment of neuropsychiatric symptoms in people with dementia, assessed by informant interview. Minimum score = 0 Maximum score = 144; Higher score denotes worse outcome. | 4 months | |
Secondary | Psychotropic medications | Use of antipsychotic and other psychotropic medications from prescribing charts | 4 months | |
Secondary | Confidence in Dementia (CODE) Scale | Staff confidence measure, self completed questionnaire. Minimum score = 9 Maximum score = 45; Higher score denotes better outcome. | 4 months | |
Secondary | Sense of Competence in Dementia Care Staff (SCIDS) scale | Perceived self efficacy of care staff, self completed questionnaire. Minimum score = 17 Maximum score = 68; Higher score denotes better outcome. | 4 months | |
Secondary | Patient Health Questionnaire (PHQ-9) | Mental Health of care staff, self reported questionnaire. Minimum score = 0 Maximum score = 27; Higher score denotes worse outcome. | 4 months | |
Secondary | EQ5D (Euroquol 5D - 5 dimensions) | 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. | 4 months | |
Secondary | Client Service Receipt Inventory | 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. | 4 months |
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