NCT01855152

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 16, 2013

Status Verified

May 1, 2013

Enrollment Period

1.6 years

First QC Date

May 9, 2013

Last Update Submit

May 13, 2013

Conditions

Dementia

Keywords

DementiaCare HomesQuality of lifeAntipsychotic medicationBehavioural symptomsCost effectivenessImplementationPerson centred careSocial interaction

Outcome Measures

Primary Outcomes (1)

  • Quality of Life (DEMQOL-proxy)

    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.

    Change in quality of life from baseline assessment point to the 9 month intervention period in both intervention and control group

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Optimised WHELD intervention

EXPERIMENTAL

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.

Other: Optimised WHELD intervention

Treatment as usual

EXPERIMENTAL

Treatments delivered as usual

Other: Treatment as usual

Interventions

Optimised WHELD interventionOTHER

Experimental: Optimised WHELD intervention

Also known as: Improving Well-being and Health for People with Dementia
Optimised WHELD intervention
Treatment as usualOTHER

Treatment delivered as usual in the care home

Treatment as usual

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE1 1UL, United Kingdom

Location

MeSH Terms

Conditions

DementiaBehavioral Symptoms

Interventions

HealthTherapeutics

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Bob Woods, Professor

    Bangor University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief investigator

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 16, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 16, 2013

Record last verified: 2013-05

Locations

GB(1)