An Optimized Person Centred Intervention to Improve Quality of Life for People With Dementia Living in Care Homes. A Cluster Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Quality of Life (DEMQOL-proxy)
Study Overview
Brief Summary
800,000 people in the United Kingdom (UK)have dementia, of which 250,000 are living in care homes. These individuals have complex mental health problems, disabilities and social needs, which if unmet will continue to adversely affect each individual, as well as the main goal of enabling people to "live well with dementia", as presented in the National Dementia Strategy (NDS) (Department of Health, 2009).
This optimized intervention WHELD is based on a factorial study and qualitative evaluation designed to facilitate the design of this current study and will combine this with the most effective elements of existing approaches to develop a comprehensive but practical intervention to improve quality of life in persons with dementia living in care homes. The intervention will combine training on person centred care, promoting person centred activities and interactions and provide care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes.
The overarching goal of this trial is to determine whether this optimised WHELD intervention is more effective in improving the quality of life and mental health, than the usual care provided people with dementia living in nursing homes. The cost effectiveness of the intervention will be assessed as well, with the aim to provide a cost effective, simple and practical intervention, improving quality of life and mental health of people with dementia in care homes; which can be rolled out nationally to all UK care homes as an National Health Service (NHS) intervention. The trial will be a randomised controlled 2-arm cluster single blind trial that will take place for 9 months across 80 care homes in UK.
Detailed Description
The main objective of this current study is to determine whether the optimised WHELD intervention, will significantly improve quality of life for people with dementia in comparison to the usual care provided in care homes.
Key secondary objectives will be to determine the specific impact of the optimised WHELD intervention on a range of outcomes including mental health and unmet needs, physical health and use of psychotropic drugs, staff attitudes and the quality of the interaction of care staff with people with dementia, person centred environment in care home settings and overall provide a cost-effective, simple and practical intervention.
We hypothesise that the intervention will significantly improve several key outcomes. Specifically we hypothesise that, compared to treatment as usual the optimised WHELD intervention will:
• Improve quality of life for people with dementia living in nursing homes
The secondary hypotheses are that the optimized WHELD intervention will:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Care homes, which identify themselves as catering for people with dementia within its literature, in the Oxfordshire, Buckinghamshire and London localities
- •Care homes which demonstrate a minimum acceptable standard of care according to Care Quality Commission (CQC)
- •All individuals residing in participating care homes who scores '1' or greater on the Clinical Dementia Rating Scale (CDR)
Exclusion Criteria
- •Less than 60% of the residents have dementia.
- •Receiving special support from local authority
- •Care home are not adequate according to CQC checks on standards of care.
- •Data will not be collected from individuals for whom consent has not been obtained
Arms & Interventions
Optimised WHELD intervention
The optimised WHELD intervention combining person centred care, promoting person centred activities and interactions and provide care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes, is more effective in improving the quality of life and mental health, than usual care for people with dementia living in nursing homes.
Intervention: Optimised WHELD intervention (Other)
Treatment as usual
Treatments delivered as usual
Intervention: Treatment as usual (Other)
Outcomes
Primary Outcomes
Quality of Life (DEMQOL-proxy)
Time Frame: Change in quality of life from baseline assessment point to the 9 month intervention period in both intervention and control group
DEMQOL-Proxy (main outcome measure) is a 31 item interviewer-administered questionnaire answered by a caregiver with the score range of 31 to 124. The The measure is also validated as a method for calculating Quality Adjusted life Year (QALY) for health economic analysis. DEMQOL (secondary outcome measure) assesses the health-related quality of life (HRQoL) for people with dementia. The measure consists of two questionnaires. DEMQOL, conducted with person with dementia is a 28 item interviewer-administered questionnaire with the score range of 28 to 112.
Secondary Outcomes
- Quality of life in late - stage dementia (QUALID)(Change in quality of life in late stage dementia measure from baseline to the 9 months of the intervention.)
- Global Deterioration Scale (GDS).(The outcome measure will be assessed prior to randomization and after 9 months of the intervention.)
- Cohen-Mansfield Agitation Inventory (CMAI)(The outcome measure will be assessed prior to randomization and after 9 months of the intervention)
- Neuropsychiatric Inventory nursing home version (NPI-NH)(The outcome measure will be assessed prior to randomization and after 9 months of the intervention)
- Cornell Scale for Depression in Dementia (CSDD)(The outcome measure will be assessed prior to randomization and after 9 months of the intervention)
- The Abbey Pain Scale(The outcome measure will be assessed prior to randomization and after 9 months of the intervention.)
- Camberwell Assessment of Need for the Elderly (CANE Version IV)(The outcome measure will be assessed prior to randomization and after 9 months of the intervention)
- Quality of Interaction Scale (QUIS)(The outcome measure will be assessed prior to randomization and after 9 months of the intervention)
- Sheffield Care Environment Assessment Matrix (SCEAM)(The outcome measure will be assessed prior to randomization and after 9 months of the intervention)
- Client Service Receipt Inventory (CSRI)(The outcome measure will be assessed prior to randomization and after 9 months of the intervention.)
Investigators
professor Clive Ballard
Chief investigator
King's College London