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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

Tracking Information
First Submitted Date  ICMJE October 13, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE March 1, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 15, 2020)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Improving Wellbeing and Health for Care Home Residents During COVID-19
Official Title  ICMJE 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
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Dementia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: WHELD training/virtual coaching programme supported with digital resources
    WHELD training/virtual coaching programme supported with digital resources
    Intervention: Other: COVID WHELD
  • No Intervention: Treatment as Usual
    Usual Best practice
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 15, 2020)
2880
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04590469
Other Study ID Numbers  ICMJE 20-21-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Exeter
Study Sponsor  ICMJE University of Exeter
Collaborators  ICMJE
  • King's College London
  • London School of Economics and Political Science
  • University of East Anglia
  • University of Hull
  • Alzheimer's Society
Investigators  ICMJE
Principal Investigator: Clive Ballard, MD The University of Exeter
PRS Account University of Exeter
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP