DementiaWHELDNCT01855152
Improving Well-being and Health for People With Dementia
A study testing Optimised WHELD intervention and Treatment as usual in people with Dementia, run by professor Clive Ballard at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Optimised WHELD intervention and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College London
London, SE1 1UL
Clive Ballard, Professor, 0207 848 8071, clive.ballard@kcl.ac.uk
Jane Fossey, PhD
About this study
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.
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.
Read the 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
- Being tested
- Optimised WHELD intervention, Treatment as usual
- Keywords
- Dementia, Care Homes, Quality of life, Antipsychotic medication, Behavioural symptoms, Cost effectiveness, Implementation, Person centred care, Social interaction
- Medical subject headings
- Dementia, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimised WHELD interventionOther
Also called Improving Well-being and Health for People with Dementia
Experimental: Optimised WHELD intervention
Treatment as usualOther
Treatment delivered as usual in the care home
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Optimised WHELD intervention |
| Treatment as usual | Experimental | Treatments delivered as usual Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The QUALID is a reliable valid scale, administered to caregivers, for rating quality of life in people with late-stage dementia. The scale measures 11 observable behaviours indicating activity and emotional states. Ratings are made for observations made over the preceding 7 days. Items are rated on a 5-point Likert scale with QUALID scores ranging from 12 to 45 points with lower scores reflecting a higher quality of life (QOL).
Measured: Change in quality of life in late stage dementia measure from baseline to the 9 months of the intervention.
Global Deterioration Scale (GDS).
The GDS is a staging scale indicating deterioration in dementia, The scale details clinical descriptions of seven major distinguishable stages, ranging from normal cognition to severe dementia. Stages 1 - 3 are the pre dementia stages. Stages 4 -7 reflect the stages of dementia. People beginning with stage 5 are no longer survive without assistance.
Measured: The outcome measure will be assessed prior to randomization and after 9 months of the intervention.
Cohen-Mansfield Agitation Inventory (CMAI)
The CMAI is a caregivers' rating questionnaire to specify agitated behaviour (Cohen-Mansfield et al, 1989). The CMAI consists of 29 items related to agitated behaviour, each of which is rated on a 7-point scale of frequency, from 1 = never to 7 = several times an hour. The rating is based on a face-to-face interview with a caregiver.
Measured: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
Neuropsychiatric Inventory nursing home version (NPI-NH)
The NPI is a validated structured interview assessment with the informant (care staff), that assesses behavioural disturbances in patients with dementia [25]. This 12-item version consists of 10 behavioural and two neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales (e.g., delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, disinhibition, elation/euphoria, apathy/indifference, irritability/lability, aberrant motor activity, sleep, and appetite/eating disorders). The frequency, severity and caregiver distress for each domain are measured. The total possible maximum score is 144. A higher score reflects increased frequency and severity of the disturbances. This specific version is developed for use in nursing homes (NPI-NH), with adapted questions in the standardized interview and the caregiver distress assessment is adapted to occupational disruptiveness.
Measured: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
Cornell Scale for Depression in Dementia (CSDD)
The CSDD is an assessment of signs and symptoms of major depression in patients with dementia. The CSDD uses a comprehensive interviewing approach that derives information via semi-structured interviews with the participant and the care staff. Many of the items during the patient interview can be filled after direct observation of the patient. The final ratings of the CSDD items represent the rater's clinical impression rather than the responses of the informant or the patient. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 as a rule are associated with absence of significant depressive symptoms.
Measured: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
The Abbey Pain Scale
The abbey pain scale is an observational brief indicator of pain for people with end-stage dementia. The scale is rated on six non verbal indicators of pain where 0 is none and 3 is severe.
Measured: 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 CANE is a comprehensive assessment assessing 24 areas of social, medical, psychological, and environmental needs. The overall rating on the CANE will be based on all the information gathered throughout the structured interview with the care staff and based on the information collected through looking at the case-note reviews and observations within the care home.
Measured: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
Quality of Interaction Scale (QUIS)
QUIS is an observational tool which measures the quality of interactions between staff and resident and personcentered environment in care home settings.
Measured: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
Sheffield Care Environment Assessment Matrix (SCEAM)
SCEAM is a comprehensive observational assessment of the care environment, which covers items such as privacy, choice and degree of control experienced by residents. Assessors require no particular training and can carry out the assessment mostly by walking through the home and directly observing the building and the way it is used in practice. The majority of items relate to the residents, but there is also a section relating specifically to staff and the provision made for them.
Measured: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
Client Service Receipt Inventory (CSRI)
The CSRI is used to estimate the cost of service packages for each participant in the study. Information is collected on the current living arrangements, use of hospital, community-based and day services over a defined retrospective of 3 months in this study. The data collected through the CSRI can be used to calculate service costs and total costs of care.
Measured: The outcome measure will be assessed prior to randomization and after 9 months of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- professor Clive Ballard
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor-investigator, professor Clive Ballard, King's College London
- Investigators
- Bob Woods, Professor, Study chair, Bangor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855152
- Sponsor's protocol ID
- Grant RP-PG-0608
- Acronym
- WHELD
- Status last verified
- May 2013
- First submitted
- 9 May 2013
- Last updated
- 16 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01855152
- Acronym / sponsor ID
- WHELD / Grant RP-PG-0608
- Conditions
- Dementia
- Keywords
- Dementia, Care Homes, Quality of life, Antipsychotic medication, Behavioural symptoms, Cost effectiveness, Implementation, Person centred care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- professor Clive BallardUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Aug 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 16 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimised WHELD intervention | Experimental | Other: Optimised WHELD interventionThe 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. |
| Treatment as usual | Experimental | Other: Treatment as usualTreatments delivered as usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimised WHELD interventionAlso: Improving Well-being and Health for People with DementiaExperimental: Optimised WHELD intervention | Other | Optimised WHELD intervention |
| Treatment as usualTreatment delivered as usual in the care home | Other | Treatment as usual |
Primary outcome
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.
10 secondary outcomes
Quality of life in late - stage dementia (QUALID)
Time frame: Change in quality of life in late stage dementia measure from baseline to the 9 months of the intervention.
Global Deterioration Scale (GDS).
Time frame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention.
Cohen-Mansfield Agitation Inventory (CMAI)
Time frame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
Neuropsychiatric Inventory nursing home version (NPI-NH)
Time frame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
Cornell Scale for Depression in Dementia (CSDD)
Time frame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
The Abbey Pain Scale
Time frame: 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)
Time frame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
Quality of Interaction Scale (QUIS)
Time frame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
Sheffield Care Environment Assessment Matrix (SCEAM)
Time frame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention
Client Service Receipt Inventory (CSRI)
Time frame: The outcome measure will be assessed prior to randomization and after 9 months of the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bob Woods, Professor study chair
Bangor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimised WHELD intervention and Treatment as usual in people with Dementia, run by professor Clive Ballard at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2013.