Researchers' experiences of the design and conduct challenges associated with parallel-group cluster-randomised trials and views on a novel open-cohort design.

BACKGROUND: Two accepted designs exist for parallel-group cluster-randomised trials (CRTs). Closed-cohort designs follow the same individuals over time with a single recruitment period before randomisation, but face challenges in settings with high attrition. (Repeated) cross-sectional designs recruit at one or more timepoints before and/or after randomisation, collecting data from different individuals present in the cluster at these timepoints, but are unsuitable for assessment of individual change over time. An 'open-cohort' design allows individual follow-up with recruitment before and after cluster-randomisation, but little literature exists on acceptability to inform their use in CRTs. AIM: To document the views and experiences of expert trialists to identify: a) Design and conduct challenges with established parallel-group CRT designs,b) Perceptions of potential benefits and barriers to implementation of open-cohort CRTs,c) Methods for minimising, and investigating the impact of, bias in open-cohort CRTs. METHODS: Qualitative consultation via two expert workshops including triallists (n = 24) who had worked on CRTs over a range of settings. Workshop transcripts were analysed using Descriptive Thematic Analysis utilising inductive and deductive coding. RESULTS: Two central organising concepts were developed. Design and conduct challenges with established CRT designs confirmed that current CRT designs are unable to deal with many of the complex research and intervention circumstances found in some trial settings (e.g. care homes). Perceptions of potential benefits and barriers of open cohort designs included themes on: approaches to recruitment; data collection; analysis; minimising/investigating the impact of bias; and how open-cohort designs might address or present CRT design challenges. Open-cohort designs were felt to provide a solution for some of the challenges current CRT designs present in some settings. CONCLUSIONS: Open-cohort CRT designs hold promise for addressing the challenges associated with standard CRT designs. Research is needed to provide clarity around definition and guidance on application.

Impact of the iWHELD digital person-centered care program on quality of life, agitation and psychotropic medications in people with dementia living in nursing homes during the COVID-19 pandemic: A randomized controlled trial.

INTRODUCTION: iWHELD is a digital person-centered care program for people with dementia in nursing homes adapted for remote delivery during the COVID-19 pandemic. METHODS: A 16-week two-arm cluster-randomized controlled trial in 149 UK nursing homes compared iWHELD with treatment as usual (TAU). Primary outcome was the overall quality of life with secondary outcomes of agitation and psychotropic use. RESULTS: iWHELD conferred benefit to quality of life on the primary (F = 4.3, p = 0.04) and secondary measures of quality of life (F = 6.45, p = 0.01) and reduced psychotropic medication use (χ2  = 4.08, p = 0.04) with no worsening of agitation. Benefit was seen in participants who contracted COVID-19, those with agitation at baseline, and those taking psychotropic medications. DISCUSSION: iWHELD confers benefits to quality of life and key measures of well-being, can be delivered during the challenging conditions of a pandemic, and should be considered for use alongside any emerging pharmacological treatment for neuropsychiatric symptoms. HIGHLIGHTS: iWHELD is the only remote, digital delivery nursing home training programme for dementia care iWHELD improved quality of life in people with dementia and reduced antipsychotic use without worsening of agitation Residents who contracted Covid-19 during the study also experienced benefits from iWHELD iWHELD offers a valuable, pandemic-safe tool for improving dementia care.

Oxford brain health clinic: protocol and research database.

INTRODUCTION: Despite major advances in the field of neuroscience over the last three decades, the quality of assessments available to patients with memory problems in later life has barely changed. At the same time, a large proportion of dementia biomarker research is conducted in selected research samples that often poorly reflect the demographics of the population of patients who present to memory clinics. The Oxford Brain Health Clinic (BHC) is a newly developed clinical assessment service with embedded research in which all patients are offered high-quality clinical and research assessments, including MRI, as standard. METHODS AND ANALYSIS: Here we describe the BHC protocol, including aligning our MRI scans with those collected in the UK Biobank. We evaluate rates of research consent for the first 108 patients (data collection ongoing) and the ability of typical psychiatry-led NHS memory-clinic patients to tolerate both clinical and research assessments. ETHICS AND DISSEMINATION: Our ethics and consenting process enables patients to choose the level of research participation that suits them. This generates high rates of consent, enabling us to populate a research database with high-quality data that will be disseminated through a national platform (the Dementias Platform UK data portal).

Impact of the Covid-19 pandemic on neuropsychiatric symptoms and antipsychotic prescribing for people with dementia in nursing home settings.

OBJECTIVES: This study aimed to determine the impact of the Covid-19 pandemic on neuropsychiatric symptoms and antipsychotic use in people with dementia living in nursing homes. METHODS: This was a comparative analysis of baseline data from two large nursing home studies, one conducted during (COVID-iWHELD study) and one prior (WHELD study) to the pandemic. It involves data from 69 and 149 nursing homes, and 1006 and 666 participants respectively. Participants were people with established dementia (score >1 on Clinical Dementia Rating Scale). Resident data included demographics, antipsychotic prescriptions and neuropsychiatric symptoms using the Neuropsychiatric Inventory Nursing Home version. Nursing home data collected were nursing home size and staffing information. RESULTS: Overall prevalence of neuropsychiatric symptoms was unchanged from pre-pandemic prevalence. Mean antipsychotic use across the sample was 32.0%, increased from 18% pre-pandemic (Fisher's exact test p < 0.0001). At a nursing home level, the medians for the low, medium and high tertiles for antipsychotic use were 7%, 20% and 59% respectively, showing a disproportionate rise in tertile three. Residents in these homes also showed a small but significant increase in agitation. CONCLUSION: There has been a significant increase in antipsychotic prescribing in nursing homes since the COVID-19 pandemic, with a disproportionate rise in one third of homes, where median prescription rates for antipsychotics were almost 60%. Strategies are urgently needed to identify these nursing homes and introduce pro-active support to bring antipsychotic prescription rates back to pre-pandemic levels.

Impact of Psychotic Symptoms and Concurrent Neuropsychiatric Symptoms on the Quality of Life of People With Dementia Living in Nursing Homes.

OBJECTIVES: The aim of the present study was to determine whether psychotic symptoms in people with dementia (PwD) living in nursing homes were associated with reduced quality of life and to understand the additional impact of other concurrent neuropsychiatric symptoms on QoL. DESIGN: Cross-sectional cohort study (using data from WHELD cohort). SETTINGS AND PARTICIPANTS: 971 PwD living in nursing homes participating in the WHELD study. METHODS: The Neuropsychiatric Inventory-Nursing Home (NPI-NH) version was completed by informant interview. We compared mean differences in proxy-rated QoL scores (DEMQOL-Proxy) for PwD experiencing or not experiencing delusions and for PwD experiencing or not experiencing hallucinations. Backward multiple regression was used to determine the added contributions of agitation (Cohen-Mansfield Agitation Inventory), anxiety (NPI-NH-Anxiety), depression (Cornell Scale for Depression in Dementia), dementia severity (Clinical Dementia Rating-sum of boxes score), pain (Abbey Pain Scale), and antipsychotic prescription. Mediation analysis was conducted for agitation, anxiety, and depression. RESULTS: Presence of both delusions (P < .001, B = -8.39) and hallucinations (P < .001, B = -7.78) was associated with poorer QoL. Both associations remained significant after controlling for other factors. Agitation, anxiety, and depression partially mediated the relationship between each psychotic symptom and QoL. CONCLUSIONS AND IMPLICATIONS: Delusions and hallucinations in PwD are associated with poorer QoL among PwD living in nursing homes. The effects remain significant after adjusting for confounding variables. Direct effects of each symptom maintained significance despite significant mediation by concurrent neuropsychiatric symptoms.

Cost-Effectiveness of an Online Intervention for Caregivers of People Living With Dementia.

OBJECTIVES: Little evidence exists on costs or cost-effectiveness of online interventions for caregivers of people living with dementia. We aimed to assess cost-effectiveness of online cognitive behavioral therapy (CBT) for dementia caregivers with mild-to-moderate depression/anxiety, with or without telephone support, relative to a psychoeducational control treatment. DESIGN: Cost-effectiveness study of data from 3-armed randomized controlled trial comparing computerized CBT (cCBT) or telephone-supported cCBT (cCBT+Telephone) to modular online educational program on dementia (Psychoeducation). SETTING AND PARTICIPANTS: UK-resident adult dementia caregivers with mild-to-moderate anxiety/depression. COST-EFFECTIVENESS ANALYSIS: We calculated health and social care costs, from participant-reported data collected at baseline, 12, 26 weeks, costs of intervention delivery. We examined 3 outcomes: cost of one-point reduction in General Health Questionnaire-12 (GHQ-12) rating at 26-weeks, cost of prevented "caseness" on GHQ-12 at 26 weeks, and cost per quality-adjusted life year (QALY) based on Short Form-6 Dimensions (SF-6D) over 26 weeks. RESULTS: Data from 176 participants (44 cCBT, 91 cCBT+Telephone, 41 Psychoeducation) were analyzed. Costs did not differ between cCBT and Psychoeducation; costs were £125 higher in cCBT+Telephone. Control and intervention groups did not differ on GHQ-12. Caseness was lower in cCBT+Telephone than Psychoeducation; cost of preventing a case was £610, and probability of cost-effectiveness on this outcome reached 98.5% at willingness to pay (WTP) of £12,900. Mean QALY did not differ between cCBT+Telephone and Psychoeducation. QALY gain in cCBT was 0.01 (95% CI 0.001, 0.021). Cost per QALY was £8130. Although base case probability of cost-effectiveness of cCBT was 93% at WTP-per-QALY of £27,600, sensitivity analyses suggested cCBT+Telephone was the more cost-effective. CONCLUSIONS AND IMPLICATIONS: We report preliminary evidence for adopting telephone-supported online CBT. This may be cost-effective in preventing a case of mental health disorder if, absent a societally accepted WTP threshold for this outcome, payers are willing to pay £12,900. Future research should investigate whether supported/unsupported online CBT improves health-related quality of life.

Effectiveness of Dementia Care Mapping™ to reduce agitation in care home residents with dementia: an open-cohort cluster randomised controlled trial.

OBJECTIVES: Agitation is common and problematic in care home residents with dementia. This study investigated the (cost)effectiveness of Dementia Care Mapping™ (DCM) for reducing agitation in this population. METHOD: Pragmatic, cluster randomised controlled trial with cost-effectiveness analysis in 50 care homes, follow-up at 6 and 16 months and stratified randomisation to intervention (n = 31) and control (n = 19). Residents with dementia were recruited at baseline (n = 726) and 16 months (n = 261). Clusters were not blinded to allocation. Three DCM cycles were scheduled, delivered by two trained staff per home. Cycle one was supported by an external DCM expert. Agitation (Cohen-Mansfield Agitation Inventory (CMAI)) at 16 months was the primary outcome. RESULTS: DCM was not superior to control on any outcomes (cross-sectional sample n = 675: 287 control, 388 intervention). The adjusted mean CMAI score difference was -2.11 points (95% CI -4.66 to 0.44, p = 0.104, adjusted ICC control = 0, intervention 0.001). Sensitivity analyses supported the primary analysis. Incremental cost per unit improvement in CMAI and QALYs (intervention vs control) on closed-cohort baseline recruited sample (n = 726, 418 intervention, 308 control) was £289 and £60,627 respectively. Loss to follow-up at 16 months in the original cohort was 312/726 (43·0%) mainly (87·2%) due to deaths. Intervention dose was low with only a quarter of homes completing more than one DCM cycle. CONCLUSION: No benefits of DCM were evidenced. Low intervention dose indicates standard care homes may be insufficiently resourced to implement DCM. Alternative models of implementation, or other approaches to reducing agitation should be considered.

Online Education and Cognitive Behavior Therapy Improve Dementia Caregivers' Mental Health: A Randomized Trial.

OBJECTIVES: To compare online cognitive-behavioral therapy (CBT) with and without telephone support respectively to online psychoeducation in a randomized controlled trial (RCT) in caregivers of people with dementia with mild anxiety or depression. DESIGN: Three-arm parallel-group RCT comparing online CBT with and without telephone support respectively to online psychoeducation. SETTING AND PARTICIPANTS: Online study with caregivers of people with dementia. MEASURES: The primary outcome measure was mental health measured by General Health Questionnaire-12 (GHQ-12) at 26 weeks. Secondary outcomes included the Hospital Anxiety and Depression Scale (HADS); the Relative Stress Scale (RSS) and the Short Sense of Competency Questionnaire. The primary analysis focused on people completing GHQ-12 at both baseline and 26 weeks, evaluated using analysis of covariance. RESULTS: 638 people were randomized to the 3 treatment arms, of whom 208 were included in the analysis population. There were significant improvements in GHQ-12 in all treatment arms compared to baseline (P < .001 for all interventions), but neither CBT with nor without telephone support conferred any significant advantage compared to psychoeducation. For the secondary outcomes, there were no significant differences between CBT with telephone support and psychoeducation, but CBT without telephone support was less effective than psychoeducation with respect to HADS depression subscale [mean difference 1.86, 95% confidence interval (CI) 0.61, 3.11; P = .004] and caregiver stress (RSS mean difference 3.11, 95% CI 0.13, 6.09; P = .04). Good safety was achieved in all 3 treatment arms, with no deaths or serious adverse events. CONCLUSIONS AND IMPLICATIONS: Online CBT with telephone support and psychoeducation both achieved significant benefits over 26 weeks compared with baseline in mental health and mood, but there were no advantages for CBT compared with the psychoeducation intervention. CBT without telephone support was less effective with respect to mood outcomes than psychoeducation and should not be recommended based on current evidence.

Dementia Care Mapping™ to reduce agitation in care home residents with dementia: the EPIC cluster RCT.

BACKGROUND: The quality of care for people with dementia in care homes is of concern. Interventions that can improve care outcomes are required. OBJECTIVE: To investigate the clinical effectiveness and cost-effectiveness of Dementia Care Mapping™ (DCM) for reducing agitation and improving care outcomes for people living with dementia in care homes, versus usual care. DESIGN: A pragmatic, cluster randomised controlled trial with an open-cohort design, follow-up at 6 and 16 months, integrated cost-effectiveness analysis and process evaluation. Clusters were not blinded to allocation. The primary end point was completed by staff proxy and independent assessors. SETTING: Stratified randomisation of 50 care homes to the intervention and control groups on a 3 : 2 ratio by type, size, staff exposure to dementia training and recruiting hub. PARTICIPANTS: Fifty care homes were randomised (intervention, n = 31; control, n = 19), with 726 residents recruited at baseline and a further 261 recruited after 16 months. Care homes were eligible if they recruited a minimum of 10 residents, were not subject to improvement notices, had not used DCM in the previous 18 months and were not participating in conflicting research. Residents were eligible if they lived there permanently, had a formal diagnosis of dementia or a score of 4+ on the Functional Assessment Staging Test of Alzheimer's Disease, were proficient in English and were not terminally ill or permanently cared for in bed. All homes were audited on the delivery of dementia and person-centred care awareness training. Those not reaching a minimum standard were provided training ahead of randomisation. Eighteen homes took part in the process evaluation. INTERVENTION: Two staff members from each intervention home were trained to use DCM and were asked to carry out three DCM cycles; the first was supported by an external expert. MAIN OUTCOME MEASURES: The primary outcome was agitation (Cohen-Mansfield Agitation Inventory), measured at 16 months. Secondary outcomes included resident behaviours and quality of life. RESULTS: There were 675 residents in the final analysis (intervention, n = 388; control, n = 287). There was no evidence of a difference in agitation levels between the treatment arms. The adjusted mean difference in Cohen-Mansfield Agitation Inventory score was -2.11 points, being lower in the intervention group than in the control (95% confidence interval -4.66 to 0.44; p = 0.104; adjusted intracluster correlation coefficient: control = 0, intervention = 0.001). The sensitivity analyses results supported the primary analysis. No differences were detected in any of the secondary outcomes. The health economic analyses indicated that DCM was not cost-effective. Intervention adherence was problematic; only 26% of homes completed more than their first DCM cycle. Impacts, barriers to and facilitators of DCM implementation were identified. LIMITATIONS: The primary completion of resident outcomes was by staff proxy, owing to self-report difficulties for residents with advanced dementia. Clusters were not blinded to allocation, although supportive analyses suggested that any reporting bias was not clinically important. CONCLUSIONS: There was no benefit of DCM over control for any outcomes. The implementation of DCM by care home staff was suboptimal compared with the protocol in the majority of homes. FUTURE WORK: Alternative models of DCM implementation should be considered that do not rely solely on leadership by care home staff. TRIAL REGISTRATION: Current Controlled Trials ISRCTN82288852. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 16. See the NIHR Journals Library website for further project information.

Agitation is common in care home residents and may result from care that does not meet individual needs. Dementia Care Mapping™ (DCM) is a tool used within care homes to improve the delivery of person-centred care, which may help reduce agitation. This randomised controlled trial aimed to understand whether or not DCM is better than usual care at reducing resident agitation, behaviours that staff may find difficult to support and the use of antipsychotic medicines, as well as at improving residents' quality of life and staff communication. It also assessed its value for money. We recruited 726 residents with dementia from 50 care homes. After initial data collection, care homes were randomly assigned to DCM (31/50) or told to continue with usual care (19/50) and data were collected again after 6 and 16 months. A further 261 residents were recruited after 16 months. We also interviewed staff, relatives and residents about the use of DCM after the final data collection had taken place. Two staff members in each DCM home were trained to use DCM and were helped by an expert to use it for the first time. They were asked to use it again a further two times without support. Results showed that DCM was no better than usual care in relation to any of the outcomes. It was also not shown to be value for money. Only one-quarter of care homes used DCM more than once. The care staff who were interviewed said that the benefits of using DCM included reduced resident boredom and increased staff confidence. There were also many challenges, including the time needed to complete DCM, a lack of managerial support and problems with staffing levels. Putting DCM into practice in care homes was difficult, even with expert support, and most care homes did not complete three DCM cycles. Future research should explore models of implementing DCM that do not rely on care home staff to lead them.

"We should see her like part of the team": an investigation into care home staff's experiences of being part of an RCT of a complex psychosocial intervention.

Objectives: To contribute to improvements in the design and delivery of intervention research in care homes by adopting a collaborative approach that listens to the experiences of care home staff who had participated in a clinical trial aimed at optimising and evaluating a psychosocial intervention package for people with dementia.Methods: Qualitative study involving focus group discussions (FGDs) involving 41 staff across 6 care homes with the UK. Inductive thematic analysis was used to identify themes and interpret the data.Results: Three overarching themes emerged as influential: Recognising preparedness; working together and learning more than expected. The findings highlighted the need to be attentive in addressing staff expectations, the value of sustained relationships and recognition of good practice. The FGDs also identified areas of unanticipated learning that staff and managers adopted.Conclusions: The FGDs showed the importance of considering the overall experience of care home staff who are involved in research and the importance of valuing the skills and experience they hold through positive affirmation. There are often unanticipated consequences of research involvement both on staff practice and on relationships which if promoted could help sustain effective ways of working together.

Exploring the role of external experts in supporting staff to implement psychosocial interventions in care home settings: results from the process evaluation of a randomized controlled trial.

BACKGROUND: Psychosocial interventions offer opportunities to improve care for people with dementia in care homes. However, implementation is often led by staff who are not well prepared for the role. Some interventions use external experts to support staff. However little is known about external expert, care home staff and manager perceptions of such support. This paper addresses this gap. METHODS: Multi-methods study within a process evaluation of a cluster randomised controlled trial of Dementia Care Mapping™ (DCM). Interviews were conducted with six external experts who also completed questionnaires, 17 care home managers and 25 care home staff responsible for DCM implementation. Data were analysed using descriptive statistics and template analysis. RESULTS: Three themes were identified: the need for expert support, practicalities of support and broader impacts of providing support. Expert support was vital for successful DCM implementation, although the five-days provided was felt to be insufficient. Some homes felt the support was inflexible and did not consider their individual needs. Practical challenges of experts being located at a geographical distance from the care homes, limited when and how support was available. Experts gained knowledge they were able to then apply in delivering DCM training. Experts were not able to accurately predict which homes would be able to implement DCM independently in future cycles. CONCLUSIONS: An external expert may form a key component of successful implementation of psychosocial interventions in care home settings. Future research should explore optimal use of the expert role.

What influences the sustainability of an effective psychosocial intervention for people with dementia living in care homes? A 9 to 12-month follow-up of the perceptions of staff in care homes involved in the WHELD randomised controlled trail.

OBJECTIVES: The study aims to understand the factors that care home staff felt enabled or hindered them in continuing to use the well-being and health for people with dementia (WHELD) psychosocial approach in their care home and investigate whether there was sustained activity 9 to 12 months after the study ended. METHODS: This qualitative study is part of a wider clinical trial, which demonstrated effectiveness of a psychosocial intervention on quality of life outcomes and neuropsychiatric symptoms for residents. Forty-seven care home staff within nine care homes in the United Kingdom participated in focus groups, between 9 and 12 months after the intervention had finished. Inductive thematic analysis was used to identify themes and interpret the data. RESULTS: The findings highlighted that staff continued to use a range of activities and processes acquired through the research intervention, after the study had ended. Three overarching themes were identified as influential: "recognising the value" of the approach for residents and staff, "being well practiced" with sufficient support and opportunity to consolidate skills prior to the withdrawal of the researchers, and "taking ownership of the approach" to incorporate it as usual care. CONCLUSIONS: The WHELD approach can be sustained where the value of the approach is recognised, and sufficient support is provided during initial implementation for staff to build skills and confidence for it to become routine care. Further follow-up is required to understand longer term use and the impact for residents.

Improving the quality of life of care home residents with dementia: Cost-effectiveness of an optimized intervention for residents with clinically significant agitation in dementia.

INTRODUCTION: To examine whether an optimized intervention is a more cost-effective option than treatment as usual (TAU) for improving agitation and quality of life in nursing home residents with clinically significant agitation and dementia. METHODS: A cost-effectiveness analysis within a cluster-randomized factorial study in 69 care homes with 549 residents was conducted. Each cluster was randomized to receive either the Well-being and Health for people with Dementia (WHELD) intervention or TAU for nine months. Health and social care costs, agitation, and quality of life outcomes were evaluated. RESULTS: Improvements in agitation and quality of life were evident in residents allocated to the WHELD intervention group. The additional cost of the WHELD intervention was offset by the higher health and social care costs incurred by TAU group residents (mean difference, £2103; 95% confidence interval, -13 to 4219). DISCUSSION: The WHELD intervention has clinical and economic benefits when used in residents with clinically significant agitation.

Self-efficacy in dementia care staff: Experiences from the care home context.

Perceived self-efficacy is proposed to impact on the psychological health of dementia care staff. The current study adopted a qualitative methodology to increase understanding of the experiences of self-efficacious care assistants. Purposive sampling identified eight care assistants with high levels of self-efficacy. Data from semi-structured interviews were analysed using interpretative phenomenological analysis. Four themes captured experiences of 'feeling torn' between competing demands when providing care; a sense of 'togetherness and connection', included sub-themes of support, closeness and the value of engaging; 'emotional attunement' to resident's needs, including reciprocity of emotion, personal perspective-taking and empathy as guides to care. The final theme, 'caring as a part of life', described interest, motivation and accepting attitudes as well as caring being part of carers' identity. The themes highlight how staff might manage the dilemmas they face and emphasize important areas for care staff training as well as further research.

Impact of person-centred care training and person-centred activities on quality of life, agitation, and antipsychotic use in people with dementia living in nursing homes: A cluster-randomised controlled trial.

BACKGROUND: Agitation is a common, challenging symptom affecting large numbers of people with dementia and impacting on quality of life (QoL). There is an urgent need for evidence-based, cost-effective psychosocial interventions to improve these outcomes, particularly in the absence of safe, effective pharmacological therapies. This study aimed to evaluate the efficacy of a person-centred care and psychosocial intervention incorporating an antipsychotic review, WHELD, on QoL, agitation, and antipsychotic use in people with dementia living in nursing homes, and to determine its cost. METHODS AND FINDINGS: This was a randomised controlled cluster trial conducted between 1 January 2013 and 30 September 2015 that compared the WHELD intervention with treatment as usual (TAU) in people with dementia living in 69 UK nursing homes, using an intention to treat analysis. All nursing homes allocated to the intervention received staff training in person-centred care and social interaction and education regarding antipsychotic medications (antipsychotic review), followed by ongoing delivery through a care staff champion model. The primary outcome measure was QoL (DEMQOL-Proxy). Secondary outcomes were agitation (Cohen-Mansfield Agitation Inventory [CMAI]), neuropsychiatric symptoms (Neuropsychiatric Inventory-Nursing Home Version [NPI-NH]), antipsychotic use, global deterioration (Clinical Dementia Rating), mood (Cornell Scale for Depression in Dementia), unmet needs (Camberwell Assessment of Need for the Elderly), mortality, quality of interactions (Quality of Interactions Scale [QUIS]), pain (Abbey Pain Scale), and cost. Costs were calculated using cost function figures compared with usual costs. In all, 847 people were randomised to WHELD or TAU, of whom 553 completed the 9-month randomised controlled trial. The intervention conferred a statistically significant improvement in QoL (DEMQOL-Proxy Z score 2.82, p = 0.0042; mean difference 2.54, SEM 0.88; 95% CI 0.81, 4.28; Cohen's D effect size 0.24). There were also statistically significant benefits in agitation (CMAI Z score 2.68, p = 0.0076; mean difference 4.27, SEM 1.59; 95% CI -7.39, -1.15; Cohen's D 0.23) and overall neuropsychiatric symptoms (NPI-NH Z score 3.52, p < 0.001; mean difference 4.55, SEM 1.28; 95% CI -7.07,-2.02; Cohen's D 0.30). Benefits were greatest in people with moderately severe dementia. There was a statistically significant benefit in positive care interactions as measured by QUIS (19.7% increase, SEM 8.94; 95% CI 2.12, 37.16, p = 0.03; Cohen's D 0.55). There were no statistically significant differences between WHELD and TAU for the other outcomes. A sensitivity analysis using a pre-specified imputation model confirmed statistically significant benefits in DEMQOL-Proxy, CMAI, and NPI-NH outcomes with the WHELD intervention. Antipsychotic drug use was at a low stable level in both treatment groups, and the intervention did not reduce use. The WHELD intervention reduced cost compared to TAU, and the benefits achieved were therefore associated with a cost saving. The main limitation was that antipsychotic review was based on augmenting processes within care homes to trigger medical review and did not in this study involve proactive primary care education. An additional limitation was the inherent challenge of assessing QoL in this patient group. CONCLUSIONS: These findings suggest that the WHELD intervention confers benefits in terms of QoL, agitation, and neuropsychiatric symptoms, albeit with relatively small effect sizes, as well as cost saving in a model that can readily be implemented in nursing homes. Future work should consider how to facilitate sustainability of the intervention in this setting. TRIAL REGISTRATION: ISRCTN Registry ISRCTN62237498.

Caring For Me and You: the co-production of a computerised cognitive behavioural therapy (cCBT) package for carers of people with dementia.

OBJECTIVES: Carers of people with dementia face barriers in accessing therapy for mental health difficulties. Computerised cognitive behavioural therapy (cCBT) packages can be effective in treating a range of presentations; however, tailored packages for carers' unique needs are lacking. Our aim was to design a cCBT package for carers to address the limitations of previous online interventions, by including users and experts as consultants and collaborators throughout the project. METHOD: We adopted a three-phase approach to the development process. Firstly, a data-gathering phase in which current literature and best practice was reviewed, and semi-structured interviews conducted with service users, academic and clinical experts. Secondly, a co-production and refinement phase with carers testing materials and providing feedback. Thirdly, a pilot field testing phase of service users and the research team testing the package. RESULTS: The 'Caring For Me and You' package adopted a transdiagnostic approach to take account of the range of difficulties that carers face. The package consisted of 20 short sessions with features built in to engage users and personalise content to meet individuals' needs. CONCLUSION: User involvement was central to the design of the 'Caring For Me and You' package which is currently being evaluated in a three-arm randomised controlled trial.

Epidemiology of Pain in People With Dementia Living in Care Homes: Longitudinal Course, Prevalence, and Treatment Implications.

INTRODUCTION: Knowledge regarding the longitudinal course, impact, or treatment implications of pain in people with dementia living in care homes is very limited. METHODS: We investigated the people with dementia living in 67 care homes in London and Buckinghamshire, United Kingdom. Pain, dementia severity, neuropsychiatric symptoms, depression, agitation, and quality-of-life were measured using appropriate instruments at baseline (N = 967) and after 9 months (n = 629). RESULTS: Baseline prevalence of pain was 35.3% (95% CI 32.3-38.3). Pain severity was significantly correlated with dementia severity, neuropsychiatric symptoms, depression, agitation, and quality of life at both time points. Regular treatment with analgesics significantly reduced pain severity. Pain was significantly associated with more antipsychotic prescriptions. Pain was significantly associated (OR 1.48; 95% CI 1.18-1.85) with all-cause mortality during follow-up. CONCLUSIONS: Pain is an important determinant of neuropsychiatric symptoms, mortality, quality-of-life, and antipsychotic prescriptions. Improved identification, monitoring, and treatment of pain are urgent priorities to improve the health and quality-of-life for people with dementia.

The cost of care homes for people with dementia in England: a modelling approach.

OBJECTIVES: To examine the cost of care for people with dementia in institutional care settings, to understand the major cost drivers and to highlight opportunities for service development. METHODS: Data on 277 residents with dementia in 16 UK residential or nursing homes were collected. We estimated care and support costs and fitted models to the data. Sensitivity analyses were also conducted. RESULTS: Care home residents cost £792 weekly: 95% of the costs accounted for by direct fees. Hospital contacts contributed the largest proportion of the additional costs. Having an established diagnosis of dementia (b = 0.070; p < 0.05) was associated with higher costs. No association was found between cost and needs (b = -0.002; p = 0.818). CONCLUSION: The absence of an association between cost and needs emphasizes the importance of a more needs-based costing system which could result in clinical and economic advantages. Copyright © 2016 John Wiley & Sons, Ltd.

Impact of antipsychotic review and non-pharmacological intervention on health-related quality of life in people with dementia living in care homes: WHELD-a factorial cluster randomised controlled trial.

BACKGROUND: Very few interventional studies have directly examined the impact of treatment approaches on health-related quality of life (HRQL) in people with dementia. This is of particular importance in therapies to address behavioural symptoms, where HRQL is often severely affected. METHODS: Analysis within the WHELD cluster randomised factorial study in 16 UK care homes examining the impact of person-centred care in combination with antipsychotic review, social interaction and exercise interventions. This study analysed impact on HRQL through the DEMQOL-Proxy. RESULTS: Data on HRQL were available for 187 participants. People receiving antipsychotic review showed a significant worsening in two DEMQOL-Proxy domains (negative emotion: p = 0.02; appearance: p = 0.04). A best-case scenario analysis showed significant worsening for total DEMQOL-Proxy score. Social interaction intervention resulted in a significant benefit to HRQL (p = 0.04). There was no deterioration in HRQL in groups receiving both antipsychotic review and social interaction (p = 0.62). CONCLUSIONS: This demonstrates an important detrimental impact of discontinuation of antipsychotics in dementia on HRQL, highlighting the need for careful review of best practice guidelines regarding antipsychotic use and emphasising the importance of providing evidence-based non-pharmacological interventions in conjunction with antipsychotic review. Copyright © 2016 John Wiley & Sons, Ltd.