Clinical trial NCT01855152: Improving Well-being and Health for People With Dementia
Official title: An Optimized Person Centred Intervention to Improve Quality of Life for People With Dementia Living in Care Homes. A Cluster Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Keywords: Dementia
Care Homes
Quality of life
Antipsychotic medication
Behavioural symptoms
Cost effectiveness
Implementation
Person centred care
Social interaction
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2013-05-16
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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:

* Reduce agitation, other behavioural and neuropsychiatric symptoms
* Reduce the use of antipsychotic and other psychotropic drugs use
* Reduce unmet needs
* Reduce mortality
* Improve mood and depression
* Improve the quality of interactions between staff and residents
* Provide person centred environment in care home settings
* Provide a cost-effective intervention

The study design is a cluster randomised controlled, 2 arms trial to be run in 80 care homes, including 960 - 1280 participants.

Each cluster in the optimised WHELD intervention arm will receive the optimised WHELD intervention for 9 months.

Evaluations will be undertaken to understand the breadth of benefits conferred by the intervention to be assessed when used in comparison with the progress of the participants residing in the care homes allocated to the TAU trial arm. Baseline and follow up data will be collected on all consented residents who meet the inclusion criteria at each participating care home.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life (DEMQOL-proxy)
timeFrame: Change in quality of life from baseline assessment point to the 9 month intervention period in both intervention and control group
Secondary outcomes:
measure: Quality of life in late - stage dementia (QUALID)
timeFrame: Change in quality of life in late stage dementia measure from baseline to the 9 months of the intervention.
measure: Global Deterioration Scale (GDS).
timeFrame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention.
measure: Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
measure: Neuropsychiatric Inventory nursing home version (NPI-NH)
timeFrame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
measure: Cornell Scale for Depression in Dementia (CSDD)
timeFrame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
measure: The Abbey Pain Scale
timeFrame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention.
measure: Camberwell Assessment of Need for the Elderly (CANE Version IV)
timeFrame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
measure: Quality of Interaction Scale (QUIS)
timeFrame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
measure: Sheffield Care Environment Assessment Matrix (SCEAM)
timeFrame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
measure: Client Service Receipt Inventory (CSRI)
timeFrame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: Bangor University
name: Bob Woods, Professor
role: STUDY_CHAIR
References: