Plain English Summary
Background and study aims
800,000 people in the UK have dementia, of which 250,000 are living in care homes. These people have complex mental health problems, disabilities and social needs, which needs to be met by qualified care staff to improve their quality of life. The government wants to try and improve training of staff working in care homes and reduce the unnecessary use of sedative drugs. We are trying to find out whether a new training programme that we have developed to help staff in care homes benefit the residents within the care homes receiving the training, by improving quality of life and mental health. This training will combine person-centred care, promoting person-centred activities and interactions and provide care home staff and general practitioners with updated knowledge regarding correct use of medications for persons with dementia in care homes. If this training successfully improves life of people with dementia in care homes, it can be rolled out nationally to all UK care homes.
Who can participate?
Nursing home resident with dementia in participating nursing homes will be invited to participate in the study.
What does the study involve?
The participating care homes will be randomly allocated to two groups where one group of care homes taking part will receive the training and the other group will continue to provide their usual care for 9 months. The homes that receive the training will have an additional part-time specialist nurse or similar health professional to look at ways of developing specific aspects of care. This will include training for care staff to improve the understanding of dementia, person-centred activities and interactions. This will also include education for care home staff and general practitioners to enable the best review and best use of medication to treat any behavioural or psychiatric symptoms.
What are the possible benefits and risks of participating?
The research will be very valuable in helping us to improve training of care staff and care for people with dementia in the future. There may be benefits for residents in the care homes who receive the extra training. Also sometimes people with dementia may benefit from interactions with researchers. There are limited disadvantages to taking part and no risks. There will be a short assessment for the participant which will include some questions about how they are feeling, their needs and their quality of life. This would be undertaken sensitively and with breaks as appropriate, but can sometimes be tiring or occasionally cause mild distress. No residents will receive any less care than they currently receive.
Where is the study run from?
The study will be run from 80 care homes across the UK.
When is study starting and how long is it expected to run for?
The study started in September 2013 and is expected to run until February 2015.
Who is funding the study?
National Institute for Health Research (NIHR), UK.
Who is the main contact?
Lindsey Roberts
Lindsey.Roberts@oxfordhealth.nhs.uk
Study website
Contact information
Type
Scientific
Contact name
Ms Lindsey Roberts
ORCID ID
Contact details
Fulbrook Centre
Churchill Site
Headington
Oxford
OX3 7JU
United Kingdom
-
Lindsey.Roberts@oxfordhealth.nhs.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
NCT01855152
Protocol/serial number
15116; RP-PG-0608-10133
Study information
Scientific title
An optimized person-centred intervention to improve quality of life for people with dementia living in care homes: a cluster randomized controlled trial
Acronym
WHELD
Study hypothesis
The principal research question is to determine whether the optimised intervention, combining training on person centred care, promoting person centred activities and interactions and provide care staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medication for people with dementia in care homes would significantly improve quality of life of 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 WHELD programme 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.
The secondary hypotheses are that the optimized WHELD intervention will:
1. Reduce agitation, other behavioural and neuropsychiatric symptoms
2. Reduce the use of antipsychotic and other psychotropic drugs use
3. Reduce unmet needs
4. Reduce mortality
5. Improve mood and depression
6. Improve the quality of interactions between staff and residents
7. Provide person centred environment in care home settings
8. Provide a cost-effective intervention
Ethics approval(s)
Application will be submitted to the NRES Committee - South Central - Oxford A; favourable ethical opinion was granted on 11/07/2013 and ethical approval for amendment to study protocol was approved 19/12/2013; ref:13/SC/0281
Study design
Randomised; Interventional; Design type: Process of Care
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Quality of life
Patient information sheet
Patient information not available in web format, please use contact info to request a patient information sheet
Condition
Dementia
Intervention
Care homes are randomised to two arms: Intervention and control arms
Homes in the intervention arm will receive the WHELD intervention training for 9 months. The homes within the control arm will continue to provide their usual care.
The intervention consists of a combination of elements taken from the interventions trialled in the factorial study. The WHELD intervention training will focus 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.
Intervention type
Other
Primary outcome measure
Quality of Life as measured by DEMQOL proxy. DEMQOL-Proxy is a 31 item interviewer-administered questionnaire answered by a caregiver with the score range of 31 to 124.
Secondary outcome measures
1. Quality of Life measured by DEMQOL rated with person with dementia, which is a 28 item interviewer-administered questionnaire with the score range of 28 to 112 and Quality of life in late stage dementia (QUALID), which measures 11 observable behaviours indicating activity and emotional states. Ratings are made for observations made over the preceding 7 days
2. Agitation and other behavioural and neuropsychiatric symptoms are measured by Cohen-Mansfield Agitation Inventory (CMAI) and Neuropsychiatric Inventory nursing home version, NPI-NH). 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. NPI-NH is a 12-item version consisting of 10 behavioural and two neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales.
3. Antipsychotic use and other psychotropic (sedative) drugs (number of people taking antipsychotics and dose, rated from drug charts)
4. Unmet needs are assessed by Camberwell Assessment of Need for the Elderly (CANE Version IV). CANE is a comprehensive assessment assessing 24 areas of social, medical, psychological, and environmental needs
5. Symptoms of mood and depression are measured by (Cornell Scale for Depression in Dementia - CSDD). Each item in CSDD is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe)
6. Pain is rated using the Abbey Pain Scale, which 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.
7. The quality of interactions between staff and residents and person centred environment in care home settings are rated using the observational tool Quality of Interaction Scale (QUIS)
8. Economic health evaluation will be performed by using Client Service Receipt Inventory (CSRI). The data collected through the CSRI can be used to calculate service costs and total costs of care.
Overall study start date
01/09/2013
Overall study end date
28/02/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Care homes who identify themselves as catering for people with dementia within its literature
2. Care homes should be able to demonstrate a minimum acceptable standard of care according to Care Quality Commision (CQC)
3. All individuals residing in participating care homes who meet diagnostic criteria and/or scores 1 or greater, on the Clinical Dementia Rating Scale (CDR)
Target Gender: Male & Female; Upper Age Limit 110 years ; Lower Age Limit 35 years
Participant type(s)
Patient
Age group
Senior
Sex
Both
Target number of participants
960-1280
Participant exclusion criteria
1. Less than 60% of the residents have dementia
2. Care home is receiving special support from their local authority
3. Care home has failed to meet the 5 CQC care home quality standards checks with no more than one black mark (at least one standard in this area was not being met and required improvements are required) and no red marks (at least one standard in this area was not being met and enforcement have been taken):
3.1. Standards of treating people with respect and involving them in their care
3.2. Standards of providing care, treatment & support which meets people's needs
3.3. Standards of caring for people safely & protecting them from harm
3.4. Standards of staffing
3.5. Standards of management
4. Care home unable to provide care staff champions or staff able to act as informants for participant assessments
5. Events or major changes anticipated to take place in the next 12 months, which might impact on involvement in the research
6. Care home involved in other research projects, which might affect their suitability to take part in this study or place too much burden on staff and residents
7. Undergoing systematic programme of service improvement: Involved in a systematic programme of service improvement (e.g. intensive Dementia Care Mapping)
8. Any resident for whom consent is not obtained
Recruitment start date
15/09/2013
Recruitment end date
27/03/2014
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Fulbrook Centre
Oxford
OX3 7JU
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
James Clerk Maxwell Building
Stamford Street
London
SE1 8WA
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | protocol | 12/07/2014 | Yes | No | |
Results article | results | 06/02/2018 | Yes | No | |
HRA research summary | 28/06/2023 | No | No |