Improving Wellbeing and Health for Care Home Residents During COVID-19 (COVIDWHELD)
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|ClinicalTrials.gov Identifier: NCT04590469|
Recruitment Status : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2880 participants|
|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.|
|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|
|Estimated Study Start Date :||November 20, 2020|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||January 1, 2022|
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
- 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.
- 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.
- Psychotropic medications [ Time Frame: 4 months ]Use of antipsychotic and other psychotropic medications from prescribing charts
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Clive G Ballard, MD||00441392 72 email@example.com|
|Contact: Dag Aarsland, MD||44 20 7848 firstname.lastname@example.org|
|Principal Investigator:||Clive Ballard, MD||The University of Exeter|