Improving Well-being and Health for People With Dementia

NCT ID: NCT01855152

Last Updated: 2013-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-03-31

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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Optimised WHELD intervention

Intervention Type: OTHER

Experimental: Optimised WHELD intervention

Treatment as usual

Treatments delivered as usual

Group Type: EXPERIMENTAL

Treatment as usual

Intervention Type: OTHER

Treatment delivered as usual in the care home

Interventions

Optimised WHELD intervention

Experimental: Optimised WHELD intervention

Intervention Type: OTHER

Treatment as usual

Treatment delivered as usual in the care home

Intervention Type: OTHER

Other Intervention Names

Improving Well-being and Health for People with Dementia

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

professor Clive Ballard

OTHER

Sponsor Role: lead

Responsible Party

professor Clive Ballard

Chief investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bob Woods, Professor

Role: STUDY_CHAIR

Bangor University

Locations

King's College London

London, , United Kingdom

Countries

United Kingdom

Facility Contacts

Clive Ballard, Professor

Role: primary

clive.ballard@kcl.ac.uk

0207 848 8071

Other Identifiers

Grant RP-PG-0608

Identifier Type: -

Identifier Source: org_study_id