Improving Well-being and HEaLth for people with Dementia

• Register: ISRCTN
• Last refreshed on: 9 September 2019
• Main ID: ISRCTN62237498
• Date of registration: 04/10/2013
• Prospective Registration: No
• Primary sponsor: King's College London (UK)
• Public title: Improving Well-being and HEaLth for people with Dementia
• 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
• Date of first enrolment: 15/09/2013
• Target sample size: 1280
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN62237498
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Process of Care (Quality of life)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Lindsey Roberts

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Dementia
Mental and Behavioural Disorders
Unspecified dementia

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

15116; RP-PG-0608-10133

NCT01855152

Source(s) of Monetary Support

National Institute for Health Research

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 28/02/2015