Development of an awareness-based intervention to enhance quality of life in severe dementia: trial platform

Abstract

BackgroundQuality of residential care for people with severe dementia is in urgent need of improvement. One reason for this may be the assumption that people with severe dementia are unaware of what is happening to them. However, there is converging evidence to suggest that global assumptions of unawareness are inappropriate. This trial platform study aims to assist care staff in perceiving and responding to subtle signs of awareness and thus enhance their practice.Methods/DesignIn Stage One, a measure of awareness in severe dementia will be developed. Two focus groups and an expert panel will contribute to item and scale development. In Stage Two observational data will be used to further develop the measure. Working in four care homes, we will recruit 40 individuals with severe dementia who have no, or very limited, verbal communication. Data on inter-rater reliability and frequency of all items and exploratory factor analysis will be used to identify items to be retained. Test-retest and inter-rater reliability for the new measure will be calculated. Correlations with scores for well-being and behaviour and with proxy ratings of quality of life will provide an indication of concurrent validity. In Stage Three the new measure will be used in a single blind cluster randomised trial. Eight care homes will participate, with 10 residents recruited in each giving a total sample of 80 people with severe dementia. Homes will be randomised to intervention or usual care conditions. In the intervention condition, staff will receive training in using the new measure and will undertake observations of designated residents. For residents with dementia, outcomes will be assessed in terms of change from baseline in scores for behaviour, well-being and quality of life. For care staff, outcomes will be assessed in terms of change from baseline in scores for attitudes, care practice, and well-being.DiscussionThe results will inform the design of a larger-scale trial intended to provide definitive evidence about the benefits of increasing the sensitivity of care staff to signs of awareness in residents with severe dementia.Trial RegistrationISRCTN59507580 http://www.controlled-trials.com.

AwareCare: a pilot randomized controlled trial of an awareness-based staff training intervention to improve quality of life for residents with severe dementia in long-term care settings

“…ICCs were calculated for resident and staff measures. In the protocol (Clare et al, 2010), we proposed to conduct a confirmatory factor analysis to test the hypothesized factor structure emerging from the prior measure development phase; however, during the development of the AwareCare measure (Clare et al, 2012) it became clear that the structure of the data required a different approach than the anticipated exploratory factor analysis and reliability study, and hence neither the factor analysis nor the planned calculation of the specified ICC (an index of the reliability found in the measurement study) were conducted in the current study. An additional assessment not specified in the protocol was made, and is reported, calculating ICCs to measure the effect of within-home clustering on scores for each measure reported, for the purpose of assisting power calculations if the AwareCare measure were to be used in a future cluster randomized trial.…”

“…This was a pilot cluster randomized controlled trial (for protocol see Clare et al, 2010) involving eight privately owned care homes in North Wales, UK, six specializing in dementia care and two providing care for a mixed group of older people. The care homes were randomized in pairs of similar size and type to either intervention or control conditions.…”

“…Evidence from staff training studies suggests that to be effective, training needs to include both instruction aimed at development of skills and support for the practical implementation of these skills (Kuske et al, 2007). Therefore, a combination of instruction, group supervision, and individual support was used, and staff carried out their own observations of residents between sessions using the AwareCare observational measure that was developed in a prior phase of this project (Clare et al, 2010;2012).…”

Care staff and family member perspectives on quality of life in people with very severe dementia in long-term care: a cross-sectional study

“…This paper reports a cross-sectional examination of factors associated with family member and care staff ratings of the quality of life of people with severe dementia, and examines the psychometric properties of the QUALID measure. The analysis uses data from the AwareCare study [ 18 ], including data from the initial, measure development phase [ 19 ] and data from the baseline assessments conducted for the randomised controlled trial of the awareness-based intervention [ 15 ]. The relevant National Health Service and University ethics committees gave approval for each phase of the AwareCare study.…”

AwareCare: Development and validation of an observational measure of awareness in people with severe dementia

“…This observational study was conducted with care home residents with severe dementia as part of the development work for a pilot cluster randomised controlled trial (trial registration ISRCTN59507580; for protocol see Clare, Woods, Whitaker, Wilson, & Downs, 2010). The aim was to develop and validate a reliable, valid and parsimonious observational measure of awareness in people with severe dementia that could be used easily by care staff.…”