Risk assessment for people living with dementia: a systematic review.

OBJECTIVE: This systematic review identified key components of risk assessment for people with dementia, examined attitudes toward risk identification and risk assessment, and appraised existing risk assessment tools. METHODS: Systematic searches of five databases on two platforms (EBSCO, OVID) and gray literature databases (Open Grey, Base) were conducted. Studies were screened for inclusion based on predetermined eligibility criteria and quality assessed using the Mixed Methods Appraisal Tool. Findings were tabulated and synthesized using thematic synthesis. RESULTS: Our review found people with dementia, their family carers, and healthcare professionals differed in how risk is conceptualized, with views being shaped by media perceptions, personal experiences, socio-cultural influences, dementia knowledge, and dementia severity. We found that mobilization (causing falls inside and getting lost outside) is the most frequently identified risk factor. Our findings show people with dementia are generally risk-tolerant, while healthcare professionals may adopt risk-averse approaches because of organizational requirements. We found factors that disrupt daily routines, living and caring arrangements, medication management, and unclear care pathways contribute toward adverse risk events. We discovered that most studies about risk and risk assessment scales did not consider insight of the person with dementia into risks although this is important for the impact of a risk. No risk instrument identified had sufficient evidence that it was useful. CONCLUSION: Accurate risk assessment and effective communication strategies that include the perspectives of people with dementia are needed to enable risk-tolerant practice. No risk instrument to date was shown to be widely acceptable and useful in practice.

Achieving Quality and Effectiveness in Dementia Using Crisis Teams (AQUEDUCT): a study protocol for a randomised controlled trial of a Resource Kit.

BACKGROUND: Improving care at home for people with dementia is a core policy goal in the dementia strategies of many European countries. A challenge to effective home support is the occurrence of crises in the care of people with dementia which arise from changes in their health and social circumstances. Improving the management of these crises may prevent hospital admissions and facilitate better and longer care at home. This trial is part of a National Institute for Health Research funded programme, AQUEDUCT, which aims to improve the quality and effectiveness of teams working to manage crises in dementia. METHODS/DESIGN: It is a pragmatic randomised controlled trial of an online Resource Kit to enhance practice in teams managing crises in dementia care. Thirty teams managing mental health crises in dementia in community settings will be randomised between the Resource Kit intervention and treatment as usual. The primary outcome measure is psychiatric admissions to hospital for people with dementia in the teams' catchment area recorded 6 months after randomisation. Other outcomes include quality of life measures for people with dementia and their carers, practitioner impact measures, acute hospital admissions and costs. To enhance understanding of the Resource Kit intervention, qualitative work will explore staff, patient and carers' experience. DISCUSSION: The Resource Kit intervention reflects current policy to enable home-based care for people with dementia by addressing the management of crises which threaten the viability of care at home. It is based upon a model of best practice for managing crises in dementia designed to enhance the quality of care, developed in partnership with people with dementia, carers and practitioners. If the Resource Kit is shown to be clinically and cost-effective in this study, this will enhance the probability of its incorporation into mainstream practice. TRIAL REGISTRATION: ISRCTN 42855694 ; Registered on 04/03/2021; Protocol number: 127686/2020v9; Research Ethics Committee, 09/03/2021, Ref 21/WM/0004; IRAS ID: 289982.

What are the experiences and the perceptions of service users attending Emergency Department for a mental health crisis? A systematic review.

Historically, dualistic healthcare systems have resulted in limited mental healthcare provision within physical health settings, with service users reporting poor care specifically while attending emergency departments (EDs) in a mental health crisis. Modern approaches to healthcare recognize these inequalities and are moving towards integrating healthcare systems that allow more holistic and seamless experiences for service users. This mixed-method review examines the experiences and perceptions of service users attending EDs for a mental health crisis. Systematic searches of eight databases on two platforms (EBSCO, OVID) and grey literature databases (Open Grey, Base) were conducted. Studies were systematically screened for inclusion based on predetermined eligibility criteria and quality assessed using the Mixed Methods Appraisal Tool. Findings were tabulated and synthesized using thematic synthesis. Ten studies consisting of qualitative and mixed-method designs were included in the review. Five overarching themes emerged from the synthesis: social constructs, service provider, service provision, effectiveness, and emotional impact. The findings from this review show that service users continue to have negative experiences in EDs due to stigmatizing attitudes and low skill in managing mental health needs, whereas more positive experiences are attributed to the availability of mental health liaison services. Tackling stigma, improving communication and staff training, providing calm environments, and addressing structural issues that promote better interagency working and reduce gaps in services are needed to improve mental health service user experience. Future research should focus on trauma-informed approaches in EDs to improve person-centred care for service users experiencing a mental health crisis.

Clinical and cost-effectiveness of a New psychosocial intervention to support Independence in Dementia (NIDUS-family) for family carers and people living with dementia in their own homes: a randomised controlled trial.

BACKGROUND: Most people living with dementia want to remain living in their own homes and are supported to do so by family carers. No interventions have consistently demonstrated improvements to people with dementia's life quality, functioning, or other indices of living as well as possible with dementia. We have co-produced, with health and social care professionals and family carers of people with dementia, a new intervention (NIDUS-family). To our knowledge, NIDUS-family is the first manualised intervention that can be tailored to personal goals of people living with dementia and their families and is delivered by facilitators without clinical training. The intervention utilizes components of behavioural management, carer support, psychoeducation, communication and coping skills training, enablement, and environmental adaptations, with modules selected to address dyads' selected goals. We will evaluate the effect of NIDUS-family and usual care on goal attainment, as measured by Goal Attainment Scaling (GAS) rated by family carers, compared to usual care alone at 12-month follow-up. We will also determine whether NIDUS-family and usual care is more cost-effective than usual care alone over 12 months. METHODS: A randomised, two-arm, single-masked, multi-site clinical trial involving 297 people living with dementia-family carer dyads. Dyads will be randomised 2:1 to receive the NIDUS-family intervention with usual care (n = 199) or usual care alone (n = 98). The intervention group will be offered, over 1 year, via 6-8 video call or telephone sessions (or face to face if COVID-19 restrictions allow in the recruitment period) in the initial 6 months, followed by telephone follow-ups every 1-2 months to support implementation, with a trained facilitator. DISCUSSION: Increasing the time lived at home by people living with dementia is likely to benefit lives now and in the future. Our intervention, which we adapted to include remote delivery prior to trial commencement due to the COVID-19 pandemic, aims to address barriers to living as well and as independently as possible that distress people living with dementia, exacerbate family carer(s) stress, negatively affect relationships, lead to safety risks, and frequently precipitate avoidable moves to a care home. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number ISRCTN11425138 . Registered on 7 October 2019.

Clinical effectiveness of the START (STrAtegies for RelaTives) psychological intervention for family carers and the effects on the cost of care for people with dementia: 6-year follow-up of a randomised controlled trial.

BACKGROUND: The START (STrAtegies for RelaTives) intervention reduced depressive and anxiety symptoms of family carers of relatives with dementia at home over 2 years and was cost-effective. AIMS: To assess the clinical effectiveness over 6 years and the impact on costs and care home admission. METHOD: We conducted a randomised, parallel group, superiority trial recruiting from 4 November 2009 to 8 June 2011 with 6-year follow-up (trial registration: ISCTRN 70017938). A total of 260 self-identified family carers of people with dementia were randomised 2:1 to START, an eight-session manual-based coping intervention delivered by supervised psychology graduates, or to treatment as usual (TAU). The primary outcome was affective symptoms (Hospital Anxiety and Depression Scale, total score (HADS-T)). Secondary outcomes included patient and carer service costs and care home admission. RESULTS: In total, 222 (85.4%) of 173 carers randomised to START and 87 to TAU were included in the 6-year clinical efficacy analysis. Over 72 months, compared with TAU, the intervention group had improved scores on HADS-T (adjusted mean difference -2.00 points, 95% CI -3.38 to -0.63). Patient-related costs (START versus TAU, respectively: median £5759 v. £16 964 in the final year; P = 0.07) and carer-related costs (median £377 v. £274 in the final year) were not significantly different between groups nor were group differences in time until care home (intensity ratio START:TAU was 0.88, 95% CI 0.58-1.35). CONCLUSIONS: START is clinically effective and this effect lasts for 6 years without increasing costs. This is the first intervention with such a long-term clinical and possible economic benefit and has potential to make a difference to individual carers. DECLARATIONS OF INTEREST: G.L., Z.W. and C.C. are supported by the UCLH National Institute for Health Research (NIHR) Biomedical Research Centre. G.L. and P.R. were in part supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Bart's Health NHS Trust. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. Z.W. reports during the conduct of the study; personal fees from GE Healthcare, grants from GE Healthcare, grants from Lundbeck, other from GE Healthcare, outside the submitted work.

Peer support and reminiscence therapy for people with dementia and their family carers: a factorial pragmatic randomised trial.

OBJECTIVE: The objective of this study was to evaluate peer support and reminiscence therapy, separately and together, in comparison with usual care for people with dementia and their family carers. DESIGN: Factorial pragmatic randomised trial, analysed by treatment allocated, was used for this study. SETTING: The trial ran in Community settings in England. PARTICIPANTS: People with dementia and their family carers were the participants. INTERVENTIONS: Treatment as usual (TAU) plus one of the following: one-to-one peer support to family carers from experienced carers (Carer Supporter Programme; CSP), group reminiscence therapy (Remembering Yesterday, Caring Today; RYCT) for people with dementia and carers, both or neither. MAIN OUTCOME MEASURES: Primary outcomes included health-related quality of life (SF-12) for carers and quality of life (QoL-AD) for people with dementia; secondary outcomes included quality of relationship for carers and people with dementia; both were collected by blinded assessors at baseline, 5 and 12 months (primary end point). RESULTS: Of 291 pairs recruited, we randomised 145 (50%) to CSP (71% uptake) and 194 (67%) to RYCT (61% uptake). CSP and RYCT, separately or together, were not effective in improving primary outcomes or most secondary outcomes. For CSP versus 'no CSP', adjusted difference in means was 0.52 points on the SF-12 (95% CI -1.28 to 2.32) and -0.08 points on the QoL-AD (95% CI -1.70 to 1.56). For RYCT versus 'no RYCT', the difference was 0.10 points on the SF-12 (95% CI -1.72 to 1.93) and 0.51 points on the QoL-AD (95% CI -1.17 to 2.08). However, carers reported better relationships with the people with dementia (difference 1.11, 95% CI 0.00 to 2.21, p=0.05). Comparison of combined intervention with TAU, and of intervention received, suggested differential impacts for carers and persons with dementia. CONCLUSIONS: There is no evidence from the trial that either peer support or reminiscence is effective in improving the quality of life. TRIAL REGISTRATION NUMBER: ISRCTN37956201; Results.

Cognitive-behavioural therapy for anxiety in dementia: pilot randomised controlled trial.

BACKGROUND: Anxiety is common and problematic in dementia, yet there is a lack of effective treatments. AIMS: To develop a cognitive-behavioural therapy (CBT) manual for anxiety in dementia and determine its feasibility through a randomised controlled trial. METHOD: A ten-session CBT manual was developed. Participants with dementia and anxiety (and their carers) were randomly allocated to CBT plus treatment as usual (TAU) (n = 25) or TAU (n = 25). Outcome and cost measures were administered at baseline, 15 weeks and 6 months. RESULTS: At 15 weeks, there was an adjusted difference in anxiety (using the Rating Anxiety in Dementia scale) of (-3.10, 95% CI -6.55 to 0.34) for CBT compared with TAU, which just fell short of statistical significance. There were significant improvements in depression at 15 weeks after adjustment (-5.37, 95% CI -9.50 to -1.25). Improvements remained significant at 6 months. CBT was cost neutral. CONCLUSIONS: CBT was feasible (in terms of recruitment, acceptability and attrition) and effective. A fully powered RCT is now required.

Case management approaches to home support for people with dementia.

BACKGROUND: Over 35 million people are estimated to be living with dementia in the world and the societal costs are very high. Case management is a widely used and strongly promoted complex intervention for organising and co-ordinating care at the level of the individual, with the aim of providing long-term care for people with dementia in the community as an alternative to early admission to a care home or hospital. OBJECTIVES: To evaluate the effectiveness of case management approaches to home support for people with dementia, from the perspective of the different people involved (patients, carers, and staff) compared with other forms of treatment, including 'treatment as usual', standard community treatment and other non-case management interventions. SEARCH METHODS: We searched the following databases up to 31 December 2013: ALOIS, the Specialised Register of the Cochrane Dementia and Cognitive Improvement Group,The Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL, LILACS, Web of Science (including Science Citation Index Expanded (SCI-EXPANDED) and Social Science Citation Index), Campbell Collaboration/SORO database and the Specialised Register of the Cochrane Effective Practice and Organisation of Care Group. We updated this search in March 2014 but results have not yet been incorporated. SELECTION CRITERIA: We include randomised controlled trials (RCTs) of case management interventions for people with dementia living in the community and their carers. We screened interventions to ensure that they focused on planning and co-ordination of care. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as required by The Cochrane Collaboration. Two review authors independently extracted data and made 'Risk of bias' assessments using Cochrane criteria. For continuous outcomes, we used the mean difference (MD) or standardised mean difference (SMD) between groups along with its confidence interval (95% CI). We applied a fixed- or random-effects model as appropriate. For binary or dichotomous data, we generated the corresponding odds ratio (OR) with 95% CI. We assessed heterogeneity by the I² statistic. MAIN RESULTS: We include 13 RCTs involving 9615 participants with dementia in the review. Case management interventions in studies varied. We found low to moderate overall risk of bias; 69% of studies were at high risk for performance bias.The case management group were significantly less likely to be institutionalised (admissions to residential or nursing homes) at six months (OR 0.82, 95% CI 0.69 to 0.98, n = 5741, 6 RCTs, I² = 0%, P = 0.02) and at 18 months (OR 0.25, 95% CI 0.10 to 0.61, n = 363, 4 RCTs, I² = 0%, P = 0.003). However, the effects at 10 - 12 months (OR 0.95, 95% CI 0.83 to 1.08, n = 5990, 9 RCTs, I² = 48%, P = 0.39) and 24 months (OR 1.03, 95% CI 0.52 to 2.03, n = 201, 2 RCTs, I² = 0%, P = 0.94) were uncertain. There was evidence from one trial of a reduction in the number of days per month in a residential home or hospital unit in the case management group at six months (MD -5.80, 95% CI -7.93 to -3.67, n = 88, 1 RCT, P < 0.0001) and at 12 months (MD -7.70, 95% CI -9.38 to -6.02, n = 88, 1 RCT, P < 0.0001). One trial reported the length of time until participants were institutionalised at 12 months and the effects were uncertain (hazard ratio (HR): 0.66, 95% CI 0.38 to 1.14, P = 0.14). There was no difference in the number of people admitted to hospital at six (4 RCTs, 439 participants), 12 (5 RCTs, 585 participants) and 18 months (5 RCTs, 613 participants). For mortality at 4 - 6, 12, 18 - 24 and 36 months, and for participants' or carers' quality of life at 4, 6, 12 and 18 months, there were no significant effects. There was some evidence of benefits in carer burden at six months (SMD -0.07, 95% CI -0.12 to -0.01, n = 4601, 4 RCTs, I² = 26%, P = 0.03) but the effects at 12 or 18 months were uncertain. Additionally, some evidence indicated case management was more effective at reducing behaviour disturbance at 18 months (SMD -0.35, 95% CI -0.63 to -0.07, n = 206, 2 RCTs I² = 0%, P = 0.01) but effects were uncertain at four (2 RCTs), six (4 RCTs) or 12 months (5 RCTs).The case management group showed a small significant improvement in carer depression at 18 months (SMD -0.08, 95% CI -0.16 to -0.01, n = 2888, 3 RCTs, I² = 0%, P = 0.03). Conversely, the case management group showed greater improvement in carer well-being in a single study at six months (MD -2.20 CI CI -4.14 to -0.26, n = 65, 1 RCT, P = 0.03) but the effects were uncertain at 12 or 18 months. There was some evidence that case management reduced the total cost of services at 12 months (SMD -0.07, 95% CI -0.12 to -0.02, n = 5276, 2 RCTs, P = 0.01) and incurred lower dollar expenditure for the total three years (MD= -705.00, 95% CI -1170.31 to -239.69, n = 5170, 1 RCT, P = 0.003). Data on a number of outcomes consistently indicated that the intervention group received significantly more community services. AUTHORS' CONCLUSIONS: There is some evidence that case management is beneficial at improving some outcomes at certain time points, both in the person with dementia and in their carer. However, there was considerable heterogeneity between the interventions, outcomes measured and time points across the 13 included RCTs. There was some evidence from good-quality studies to suggest that admissions to care homes and overall healthcare costs are reduced in the medium term; however, the results at longer points of follow-up were uncertain. There was not enough evidence to clearly assess whether case management could delay institutionalisation in care homes. There were uncertain results in patient depression, functional abilities and cognition. Further work should be undertaken to investigate what components of case management are associated with improvement in outcomes. Increased consistency in measures of outcome would support future meta-analysis.

Maintenance cognitive stimulation therapy: an economic evaluation within a randomized controlled trial.

BACKGROUND: Cognitive Stimulation Therapy (CST) is effective and cost-effective for people with mild-to-moderate dementia when delivered biweekly over 7 weeks. AIMS: To examine whether longer-term (maintenance) CST is cost-effective when added to usual care. METHODS: Cost-effectiveness analysis within multicenter, single-blind, pragmatic randomized controlled trial; subgroup analysis for people taking acetylcholinesterase inhibitors (ACHEIs). A total of 236 participants with mild-to-moderate dementia received CST for 7 weeks. They were randomized to either weekly maintenance CST added to usual care or usual care alone for 24 weeks. RESULTS: Although outcome gains were modest over 6 months, maintenance CST appeared cost-effective when looking at self-rated quality of life as primary outcome, and cognition (MMSE) and proxy-rated quality-adjusted life years as secondary outcomes. CST in combination with ACHEIs offered cost-effectiveness gains when outcome was measured as cognition. CONCLUSIONS: Continuation of CST is likely to be cost-effective for people with mild-to-moderate dementia.

START (STrAtegies for RelaTives) study: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manual-based coping strategy programme in promoting the mental health of carers of people with dementia.

BACKGROUND: Two-thirds of people with dementia live at home, receiving most care from family carers, about 40% of whom have clinically significant depression or anxiety. This impacts on the person with dementia, families and society, predicting care breakdown. There are currently no clinically effective and cost-effective NHS family carer interventions. OBJECTIVES: To assess the STrAtegies for RelaTives (START) intervention in the short (4 and 8 months) and long term (1 and 2 years) compared with treatment as usual (TAU). DESIGN: Randomised, parallel-group, superiority trial with blinded assessment recruiting participants 2:1 (intervention to TAU) to allow for therapist clustering. SETTING: Three UK mental health services and one neurological service. PARTICIPANTS: Family carers of people with dementia. INTERVENTION: Eight-session manual-based coping intervention delivered by supervised psychology graduates to individuals. MAIN OUTCOME MEASURES: Affective symptoms [Hospital Anxiety and Depression Scale-total (HADS-T)] and cost-effectiveness. Secondary measures: anxiety and depression symptoms and caseness, quality of life (QoL), abusive behaviour and long-term care home admission. RESULTS: Two hundred and sixty participants were randomised (173 intervention, 87 TAU). We used intention-to-treat analysis in the short term (152 intervention, 77 TAU) and in the long term (140 intervention, 69 TAU). In the short term, the intervention group had lower HADS-T [mean difference -1.80, 95% confidence interval (CI) -3.29 to -0.31; p=0.02] and higher quality-adjusted life-years (QALYs) (mean difference 0.03, 95% CI -0.01 to 0.08). Costs were no different between groups [mean £ 252 (95% CI -£ 28 to £ 565) for intervention group]. The cost-effectiveness acceptability curve showed a greater than 99% chance of being cost-effectiveness at a £ 30,000/QALY willingness-to-pay threshold and a high probability of cost-effectiveness based on the HADS-T score. Carers in the intervention group had less case-level depression [odds ratio (OR) 0.24, 95% CI 0.07 to 0.76], a trend towards reduced case-level anxiety (OR 0.30, 95% CI 0.08 to 1.05), lower Hospital Anxiety and Depression Scale-anxiety (HADS-A) (-0.91, 95% CI -1.76 to -0.07; p = 0.03) and Hospital Anxiety and Depression Scale-depression (HADS-D) (-0.91, 95% CI -1.71 to -0.10; p = 0.03) and higher Health Status Questionnaire (HSQ) QoL (mean difference 4.09, 95% CI 0.34 to 7.83). Group differences in abusive behaviour (OR 0.48, 95% CI 0.18 to 1.27) and the person with dementia's quality of life-Alzheimer's disease (QoL-AD) (mean increase 0.59, 95% CI -0.72 to 1.89) were not significant. In the long term, the intervention group had lower HADS-T (mean difference -2.58, 95% CI -4.26 to -0.90; p = 0.03) and higher QALYs (mean difference 0.03, 95% CI -0.01 to 0.06). Carers in the intervention group had less case-level depression (OR 0.14, 95% CI 0.04 to 0.53), a trend towards reduced case-level anxiety (OR 0.57, 95% CI 0.26 to 1.24), lower HADS-A (-1.16, 95% CI -2.15 to -0.18) and HADS-D (1.45, 95% CI -2.32 to -0.57), and higher HSQ (mean difference 7.47, 95% CI 2.87 to 12.08). Thirty-two (18.7%) people with dementia in the intervention group and 17 (20.2%) in TAU were admitted to a care home (hazard ratio 0.83, 95% CI 0.44 to 1.56; p = 0.56). There were no significant differences between groups in abusive behaviour (OR 0.83, 95% CI 0.36 to 1.94), the person with dementia's QoL-AD (0.17, 95% CI -1.37 to 1.70) or costs (£ 336, 95% CI -£ 223 to £ 895) for intervention group. The probability that the intervention would be seen as cost-effective at £ 30,000/QALY threshold and cost-effectiveness on the HADS-T remained high. CONCLUSIONS: The START intervention was clinically effective and cost-effective in the short and longer term. The results are robust to the sensitivity analyses performed. Future work is needed to consider mechanism of action; the effects on people with dementia in clinical terms (cognition, neuropsychiatric symptoms, longer-term care home admission); and on health and social care costs. In addition, we will explore the effects of carer abusive behaviour on the care recipient's care home admission and if this then reduces abusive behaviour. We would also like to implement START and evaluate this implementation in clinical practice. TRIAL REGISTRATION: Current Controlled Trials ISCTRN70017938.

Long-term clinical and cost-effectiveness of psychological intervention for family carers of people with dementia: a single-blind, randomised, controlled trial.

BACKGROUND: Two-thirds of people with dementia live at home supported mainly by family carers. These carers frequently develop clinical depression or anxiety, which predicts care breakdown. We aimed to assess the clinical effectiveness (long-term reduction of depression and anxiety symptoms in family carers) and cost-effectiveness of a psychological intervention called START (STrAtegies for RelaTives). METHODS: We did a randomised, parallel-group trial with masked outcome assessments in three UK mental-health services and one neurological-outpatient dementia service. We included self-identified family carers of people with dementia who had been referred in the previous year and gave support at least once per week to the person with dementia. We randomly assigned these carers, via an online computer-generated randomisation system from an independent clinical trials unit, to either START, an 8-session, manual-based coping intervention delivered by supervised psychology graduates, or treatment as usual (TAU). The primary long-term outcomes were affective symptoms (Hospital Anxiety and Depression Scale total score [HADS-T]) 2 years after randomisation and cost-effectiveness (health and social care perspectives) over 24 months. Analysis was by intention to treat, excluding carers with data missing at both 12 and 24 months. This trial is registered ISCTRN70017938. FINDINGS: From November 4, 2009, to June 8, 2011, we recruited 260 carers. 173 carers were randomly assigned to START and 87 to TAU. Of these 260 participants, 209 (80%) were included in the clinical efficacy analysis (140 START, 69 TAU). At 24 months, compared with TAU the START group was significantly better for HADS-T (mean difference -2·58 points, 95% CI -4·26 to -0·90; p=0·003). The intervention is cost effective for both carers and patients (67% probability of cost-effectiveness at the £20 000 per QALY willingness-to-pay threshold, and 70% at the £30 000 threshold). INTERPRETATION: START is clinically effective, improving carer mood and anxiety levels for 2 years. Carers in the control TAU group were seven times more likely to have clinically significant depression than those receiving START. START is cost effective with respect to carer and patient outcomes, and National Institute for Health and Care Excellence (NICE) thresholds. The number of people with dementia is rapidly growing, and policy frameworks assume that their families will remain the frontline providers of (unpaid) support. This cost-neutral intervention, which substantially improves family-carers' mental health and quality of life, should therefore be widely available. FUNDING: National Institute for Health Research Health Technology Assessment programme 08/14/06.

Cost effectiveness of a manual based coping strategy programme in promoting the mental health of family carers of people with dementia (the START (STrAtegies for RelaTives) study): a pragmatic randomised controlled trial.

OBJECTIVE: To assess whether the START (STrAtegies for RelatTives) intervention added to treatment as usual is cost effective compared with usual treatment alone. DESIGN: Cost effectiveness analysis nested within a pragmatic randomised controlled trial. SETTING: Three mental health and one neurological outpatient dementia service in London and Essex, UK. PARTICIPANTS: Family carers of people with dementia. INTERVENTION: Eight session, manual based, coping intervention delivered by supervised psychology graduates to family carers of people with dementia added to usual treatment, compared with usual treatment alone. PRIMARY OUTCOME MEASURES: Costs measured from a health and social care perspective were analysed alongside the Hospital Anxiety and Depression Scale total score (HADS-T) of affective symptoms and quality adjusted life years (QALYs) in cost effectiveness analyses over eight months from baseline. RESULTS: Of the 260 participants recruited to the study, 173 were randomised to the START intervention, and 87 to usual treatment alone. Mean HADS-T scores were lower in the intervention group than the usual treatment group over the 8 month evaluation period (mean difference -1.79 (95% CI -3.32 to -0.33)), indicating better outcomes associated with the START intervention. There was a small improvement in health related quality of life as measured by QALYs (0.03 (-0.01 to 0.08)). Costs were no different between the intervention and usual treatment groups (£252 (-28 to 565) higher for START group). The cost effectiveness calculations suggested that START had a greater than 99% chance of being cost effective compared with usual treatment alone at a willingness to pay threshold of £30,000 per QALY gained, and a high probability of cost effectiveness on the HADS-T measure. CONCLUSIONS: The manual based coping intervention START, when added to treatment as usual, was cost effective compared with treatment as usual alone by reference to both outcome measures (affective symptoms for family carers, and carer based QALYs). TRIAL REGISTRATION: ISCTRN 70017938.

An overview of the LASER-AD study: a longitudinal epidemiological study of people with Alzheimer's disease.

Research into the epidemiological, clinical characteristics and economic impact of dementia is critical to increase understanding and better inform care and policy, and empower people with Alzheimer's disease (AD) and their families to make preparations and timely decisions about accommodation, care and treatment. The LASER-AD longitudinal study of people with AD and their carers has contributed to our understanding of the progression, characteristics and costs of the disease, and to developing tools that help detect dementia earlier, and screen and identify problems experienced by carers. Our work on quality of life shows that even those with severe dementia can report this meaningfully, although family proxy ratings of quality of life do not necessarily mirror the views of the individual. Despite the impact of the disease process, people with AD experience well-being in adversity and still live fulfilling lives. The study highlights the high prevalence and severity of neuropsychiatric symptoms, carer anxiety, depression and abusive behaviour. It informs future directions for possible interventions, in particular the central role of carer coping strategies in predicting carer mental illness. Current research is building on our findings, which have also been used to inform national and international plans for managing people with dementia and their carers.

Cognitive behavioural therapy (CBT) for anxiety in people with dementia: study protocol for a randomised controlled trial.

BACKGROUND: Many people with dementia experience anxiety, which can lead to decreased independence, relationship difficulties and increased admittance to care homes. Anxiety is often treated with antipsychotic medication, which has limited efficacy and serious side effects. Cognitive behavioural therapy (CBT) is widely used to treat anxiety in a range of populations, yet no RCTs on CBT for anxiety in dementia exist. This study aims to develop a CBT for anxiety in dementia manual and to determine its feasibility in a pilot RCT. METHODS/DESIGN: Phase I involves the development of a CBT for anxiety in dementia manual, through a process of (1) focus groups, (2) comprehensive literature reviews, (3) expert consultation, (4) a consensus conference and (5) field testing. Phase II involves the evaluation of the manual with 50 participants with mild to moderate dementia and anxiety (and their carers) in a pilot, two-armed RCT. Participants will receive either ten sessions of CBT or treatment as usual. Primary outcome measures are anxiety and costs. Secondary outcome measures are participant quality of life, behavioural disturbance, cognition, depression, mood and perceived relationship with the carer, and carer mood and perceived relationship with the person with dementia. Measures will be administered at baseline, 15 weeks and 6 months. Approximately 12 qualitative interviews will be used to gather service-users' perspectives on the intervention. DISCUSSION: This study aims to determine the feasibility of CBT for people with anxiety and dementia and provide data on the effect size of the intervention in order to conduct a power analysis for a definitive RCT. The manual will be revised according to qualitative and quantitative findings. Its publication will enable its availability throughout the NHS and beyond. TRIAL REGISTRATION: ISRCTN64806852.

Maintenance Cognitive Stimulation Therapy (CST) for dementia: a single-blind, multi-centre, randomized controlled trial of Maintenance CST vs. CST for dementia.

BACKGROUND: Psychological treatments for dementia are widely used in the UK and internationally, but only rarely have they been standardised, adequately evaluated or systematically implemented. There is increasing recognition that psychosocial interventions may have similar levels of effectiveness to medication, and both can be used in combination. Cognitive Stimulation Therapy (CST) is a 7-week cognitive-based approach for dementia that has been shown to be beneficial for cognition and quality of life and is cost-effective, but there is less conclusive evidence for the effects of CST over an extended period. METHODS/DESIGN: This multi-centre, pragmatic randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of Maintenance CST groups for dementia compares a intervention group who receive CST for 7 weeks followed by the Maintenance CST programme once a week for 24 weeks with the control group who receive CST for 7 weeks, followed by treatment as usual for 24 weeks.The primary outcome measures are quality of life of people with dementia assessed by the QoL-AD and cognition assessed by the ADAS-Cog. Secondary outcomes include the person with dementia's mood, behaviour, activities of daily living, ability to communicate and costs; as well as caregiver health-related quality of life. Using a 5% significance level, comparison of 230 participants will yield 80% power to detect a standardised difference of 0.39 on the ADAS-Cog between the groups. The trial includes a cost-effectiveness analysis from a public sector perspective. DISCUSSION: A pilot study of longer-term Maintenance CST, offering 16 weekly sessions of maintenance following the initial CST programme, previously found a significant improvement in cognitive function (MMSE) for those on the intervention group. The study identified the need for a large-scale, multi-centre RCT to define the potential longer-term benefits of continuing the therapy. This study aims to provide definitive evidence of the potential efficacy of maintenance CST and establish how far the long-term benefits can be compared with antidementia drugs such as cholinesterase inhibitors.

A cluster randomised controlled trial to reduce the unmet needs of people with dementia living in residential care.

BACKGROUND: Older people with dementia living in residential care have complex unmet needs and decreased quality of life. AIM: To reduce unmet needs in older people with dementia in residential care compared to a 'care as usual' control group. METHOD: A single blind, multicentre, cluster randomised controlled trial recruited 238 people aged 60+ with dementia living in 24 residential homes from three areas. Unmet needs were measured using the Camberwell Assessment of Needs for the Elderly (CANE) and quality of life using the Quality of Life in Alzheimer's Disease (QoL-AD). Homes were randomised to the control (care as usual) or the intervention group 1 hour per week liaison input per home to deliver a personalised intervention package over a 20 weeks to meet the unmet needs. RESULTS: A single blind follow-up included 192 (81%) available participants. At follow-up the total number of unmet needs was reduced in both the intervention and control groups, but analysing the groups by clusters there were no significant differences in either unmet needs or quality of life. CONCLUSIONS: The unmet needs of people with dementia can be identified using the CANE. The CANE assessment may have led to unmet needs being reduced at follow up, but the liaison intervention did not significantly reduce total unmet needs relative to the control group. Unmet needs such as sensory problems, mobility, drugs, and psychological distress were especially reduced in the intervention group at follow up.