Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT04590469
Status:
WITHDRAWN
Last Update Posted:
2024-05-22
First Post:
2020-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Wellbeing and Health for Care Home Residents During COVID-19
Sponsor:
University of Exeter
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no longer registered
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVIDWHELD
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.
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.
Detailed Description:
COVID E-WHELD: Effectiveness and Cost-Effectiveness
COVID-19 adapted WHELD (with digital resources and virtual coaching) will be compared to usual care in a 4 month randomized, parallel group, cluster RCT with 1280 care homes (allowing for 75% drop out because of COVID-19 outbreaks). Care homes will be randomly assigned to WHELD or treatment as usual in a 1:1 ratio. All care homes receiving treatment as usual will be offered the WHELD intervention after 4 months.
Recruitment will build upon a number of networks and contacts. The investigators already have a network of more than 1300 care homes who would be our first point of contact (100 additional care homes from Biomedical Research Centre (BRC) care home network. The investigators have a long established and successful record of recruiting large numbers of care homes to clinical trials (WHELD programme, FITS programme, Pimavanserin programme which involved more than 160 care homes).
Evaluation will be undertaken at baseline, 4 weeks and 4 months post-baseline.
The primary outcome measure will be quality of life in care home residents at 4 months, measured by the DEMQOL proxy, which has shown significant benefits in previous WHELD RCTs. The secondary outcomes will include cost-effectiveness (EQ-5D), health utilization, use of sedative medications (anti psychotics, hypnotics), neuropsychiatric symptoms, staff confidence (CODE), staff self-efficacy (SCIDS) and staff mental health (PHQ9) and a COVID-19 tracker.
Process measures collected by coaches will include Goal Attainment,
Assessments will be conducted by telephone or Microsoft Teams, by trained Research Assistants, or with the added option of being collected digitally for staff self-report measures.
Data will also be collected on numbers of remote health and social care (HSC) consultations and on unplanned hospital attendances/admissions (including fall-related injuries). Researchers will also fully cost the COVID eWHELD intervention. To examine the opportunity costs of the intervention, champions will be asked to identify activities that were not undertaken in order to participate and to report any paid and unpaid overtime related to time spent in the champion role. Unit costs will be obtained from nationally applicable sources (PSSRU UC, NHS Reference costs) or calculated anew where necessary.
Key elements of the WHELD intervention include:
* Coaching/training to deliver the WHELD programme which includes person-centred care and person-centred activities and person-centred care plans.
* A COVID-19 specific resource toolkit - digital bite-sized practical content to stay connected, develop new routines, how to respond to virus-related fear and anxiety
* Facilitated online peer support network for care home managers to share stories and solutions for COVID-19 challenges
* Pooling insights from others to create short, digestible digital resources, such as: checklists, video tips, one-page guides, do's and don'ts, infographics, etc.
* Providing communal, collaborative online group supervision calls, to promote staff well-being and peer-to-peer communities in an online gathering place
* Developing easy reference guides to enable staff to support residents, where appropriate, to use virtual communication tools to stay connected with family and friends
* Providing a series of suggestions, activities, and games all designed to foster connection during a time of isolation
As the intervention is optimized best practice, the researchers would consider this activity as service delivery and not research. The research element is the evaluation of potential benefits for residents and staff, and the evaluation of cost-effectiveness.
Analyses and reporting will follow CONSORT guidance. A full statical analysis plan will be developed during the initial phases of the project and signed off prior to database lock.
The UK Clinical Research Collaboration (UKCRC)-registered Exeter Clinical Trials Unit will be fully involved in the design, management and governance of the RCT aspects of the trial. The unit will have input into the methodology, provide central trial management/senior oversight, build and test the required data collection systems, undertake randomization, manage the data and ensure a surrounding quality assurance framework.
Care homes will specifically be able to pause participation in the study if there is a COVID-19 outbreak in the care home.
COVID-19 adapted WHELD (with digital resources and virtual coaching) will be compared to usual care in a 4 month randomized, parallel group, cluster RCT with 1280 care homes (allowing for 75% drop out because of COVID-19 outbreaks). Care homes will be randomly assigned to WHELD or treatment as usual in a 1:1 ratio. All care homes receiving treatment as usual will be offered the WHELD intervention after 4 months.
Recruitment will build upon a number of networks and contacts. The investigators already have a network of more than 1300 care homes who would be our first point of contact (100 additional care homes from Biomedical Research Centre (BRC) care home network. The investigators have a long established and successful record of recruiting large numbers of care homes to clinical trials (WHELD programme, FITS programme, Pimavanserin programme which involved more than 160 care homes).
Evaluation will be undertaken at baseline, 4 weeks and 4 months post-baseline.
The primary outcome measure will be quality of life in care home residents at 4 months, measured by the DEMQOL proxy, which has shown significant benefits in previous WHELD RCTs. The secondary outcomes will include cost-effectiveness (EQ-5D), health utilization, use of sedative medications (anti psychotics, hypnotics), neuropsychiatric symptoms, staff confidence (CODE), staff self-efficacy (SCIDS) and staff mental health (PHQ9) and a COVID-19 tracker.
Process measures collected by coaches will include Goal Attainment,
Assessments will be conducted by telephone or Microsoft Teams, by trained Research Assistants, or with the added option of being collected digitally for staff self-report measures.
Data will also be collected on numbers of remote health and social care (HSC) consultations and on unplanned hospital attendances/admissions (including fall-related injuries). Researchers will also fully cost the COVID eWHELD intervention. To examine the opportunity costs of the intervention, champions will be asked to identify activities that were not undertaken in order to participate and to report any paid and unpaid overtime related to time spent in the champion role. Unit costs will be obtained from nationally applicable sources (PSSRU UC, NHS Reference costs) or calculated anew where necessary.
Key elements of the WHELD intervention include:
* Coaching/training to deliver the WHELD programme which includes person-centred care and person-centred activities and person-centred care plans.
* A COVID-19 specific resource toolkit - digital bite-sized practical content to stay connected, develop new routines, how to respond to virus-related fear and anxiety
* Facilitated online peer support network for care home managers to share stories and solutions for COVID-19 challenges
* Pooling insights from others to create short, digestible digital resources, such as: checklists, video tips, one-page guides, do's and don'ts, infographics, etc.
* Providing communal, collaborative online group supervision calls, to promote staff well-being and peer-to-peer communities in an online gathering place
* Developing easy reference guides to enable staff to support residents, where appropriate, to use virtual communication tools to stay connected with family and friends
* Providing a series of suggestions, activities, and games all designed to foster connection during a time of isolation
As the intervention is optimized best practice, the researchers would consider this activity as service delivery and not research. The research element is the evaluation of potential benefits for residents and staff, and the evaluation of cost-effectiveness.
Analyses and reporting will follow CONSORT guidance. A full statical analysis plan will be developed during the initial phases of the project and signed off prior to database lock.
The UK Clinical Research Collaboration (UKCRC)-registered Exeter Clinical Trials Unit will be fully involved in the design, management and governance of the RCT aspects of the trial. The unit will have input into the methodology, provide central trial management/senior oversight, build and test the required data collection systems, undertake randomization, manage the data and ensure a surrounding quality assurance framework.
Care homes will specifically be able to pause participation in the study if there is a COVID-19 outbreak in the care home.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: