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Background: The MEETINGDEM study aims to implement and evaluate an innovative, inclusive, approach to supporting community dwelling people with mild to moderate dementia and their family carers, called the Meeting Centers Support Program (MCSP), in three countries in the European Union (EU): Italy, Poland and United Kingdom. Demonstrated benefits of this person-centered approach, developed in The Netherlands, include high user satisfaction, reduced behavioral and mood problems, delayed admission to residential care, lower levels of caregiving-related stress, higher carer competence, and improved collaboration between care and welfare organizations.Methods: The project will be carried out over a 36 month period. Project partners in the three countries will utilize, and adapt, strategies and tools developed in the Netherlands. In Phase One (month 1-18) activities will focus on establishing an initiative group of relevant organizations and user representatives in each country, exploring pathways to care and potential facilitators and barriers to implementing the program, and developing country specific implementation plans and materials. In Phase Two (month 19‑36) training will be provided to organizations and staff, after which the meeting centers will be established and evaluated for impact on behavior, mood and quality of life of people with dementia and carers, cost-effectiveness, changes in service use, user satisfaction and implementation process.Discussion: An overall evaluation will draw together findings from the three countries to develop recommendations for successful implementation of MCSP across the EU. If the Meeting Centers approach can be widely implemented, this could lead to major improvements in dementia care across Europe and beyond.Trial Registration: The trial was retrospectively registered in May 2016: trial number: NTR5936 . [ABSTRACT FROM AUTHOR]

Background: Despite growing recognition of essential human rights, people with mental health conditions and psychosocial, intellectual, or cognitive disabilities' rights are known to be frequently violated in mental healthcare worldwide, with common use of coercive practices and limited recognition of people's right to exercise their legal capacity and make decisions for themselves on treatment and other issues affecting them. To tackle this issue, Ghana adopted the WHO QualityRights Initiative in 2019. This aims to introduce a right-based, person-centred recovery approach within the mental health care system, protecting and promoting the rights of people with mental health conditions, psychosocial, cognitive, and intellectual disabilities in the healthcare context and community., Methods: E-training (capacity-building) was provided in Ghana across a broad array of stakeholder groups including healthcare professionals, carers, and people with lived experience. The training covered legal capacity, coercion, community inclusion, recovery approach, service environment, and the negative attitudes commonly held by stakeholder groups; it was completed by 17,000 people in Ghana as of December 2021. We assessed the impact of the e-training on attitudes through comparing trainees' pre- and post-questionnaire responses on 17 items, each measured on a 5-point Likert scale (strongly disagree to strongly agree), such that higher scores indicated negative attitudes towards persons with mental health conditions and psychosocial disabilities as rights holders. Analyses were conducted on two main groups: matched pairs (417 pairs of baseline and follow-up questionnaire responses matched to a high degree of certainty), and the unmatched group (4299 individual completed questionnaire responses)., Results: We assessed the impact of the WHO QualityRights e-training on attitudes: training resulted in highly significant attitude changes towards alignment with human rights, with scores changing by approximately 40% between baseline and follow-up. In particular, attitude changes were seen in items representing treatment choice, legal capacity, and coercion. This change was not affected by age, gender, or background experience., Conclusions: The QualityRights e-training programme is effective in changing people's (especially healthcare professionals') attitudes towards people with mental health conditions and psychosocial, intellectual, or cognitive disabilities: this is a step towards mental healthcare being more with human rights-based worldwide., (© 2023. The Author(s).)

Background: There are currently major efforts underway in Ghana to address stigma and discrimination, and promote the human rights of those with mental health conditions, within mental health services and the community, working with the World Health Organization's QualityRights initiative. The present study aims to investigate attitudes towards people with lived experience of mental health conditions and psychosocial disabilities as rights holders., Methods: Stakeholders within the Ghanaian mental health system and community, including health professionals, policy makers, and persons with lived experience, completed the QualityRights pre-training questionnaire. The items examined attitudes towards coercion, legal capacity, service environment, and community inclusion. Additional analyses explored how far participant factors may link to attitudes., Results: Overall, attitudes towards the rights of persons with lived experience were not well aligned with a human rights approach to mental health. Most people supported the use of coercive practices and often thought that health practitioners and family members were in the best position to make treatment decisions. Health/mental health professionals were less likely to endorse coercive measures compared to other groups., Conclusion: This was the first in-depth study assessing attitudes towards persons with lived experience as rights holders in Ghana, and frequently attitudes did not comply with human rights standards, demonstrating a need for training initiatives to combat stigma and discrimination and promote human rights., (© 2023. The Author(s).)

Background: With an increasingly ageing population worldwide, the predominant attitude towards ageing is still negative. Negative stereotypes have detrimental effects on individuals' physical and mental health. Evidence is required about factors that may predict and change these views. This study aimed to investigate if an older person's attitude towards dementia, their belief in a just world and sense of coherence is associated with their attitudes to ageing., Methods: A 25-min online survey was completed by 2,675 participants aged 50 or over who were current residents of the United Kingdom (UK). Questions included demographics, overall health, dementia carer, dementia relative status and retirement status. Standardised scales used were the Attitudes to Ageing Questionnaire (AAQ), Dementia Attitudes Scale (DAS), Just World Scale (JWS) and Sense of Coherence Scale-13 (SOC). Data was analysed with descriptive, two-tailed bivariate Pearson's correlations, simple, and hierarchical regression analyses., Results: Attitudes to dementia, just world beliefs, and sense of coherence were all significantly positively correlated with AAQ-Total, with SOC sub-scale "Meaningfulness" showing the strongest correlation. In a hierarchical regression model, higher scores on SOC-Meaningfulness, DAS-Total and belief in a just world for oneself all predicted more positive attitudes to ageing., Conclusions: The more positive an individual's attitude to dementia and the stronger they hold the belief that the world is just and coherent, the more likely they are to display positive attitudes to ageing. This initial evidence helps create a greater understanding of the factors that drive attitudes and stigma and may have implications for public health messaging., (© 2022. The Author(s).)

Background: In 2012, Ghana ratified the United Nations Convention on the Rights of Persons with Disabilities and enacted a Mental Health Act to improve the quality of mental health care and stop human rights violations against people with mental health conditions. In line with these objectives, Ghanaian stakeholders collected data on the quality of mental health services and respect for human rights in psychiatric facilities to identify challenges and gather useful information for the development of plans aimed to improve the quality of the services offered. This study aimed to assess psychiatric facilities from different Ghanaian regions and provide evidence on the quality of care and respect of human rights in mental health services., Methods: Assessments were conducted by independent visiting committees that collected data through observation, review of documentation, and interviews with service users, staff, and carers, and provided scores using the World Health Organization QualityRights Toolkit methodology., Results: This study revealed significant key challenges in the implementation of the United Nations Convention on the Rights of Persons with Disabilities principles in Ghanaian psychiatric services. The rights to an adequate standard of living and enjoyment of the highest attainable standard of health were not fully promoted. Only initial steps had been taken to guarantee the right to exercise legal capacity and the right to personal liberty and security. Significant gaps in the promotion of the right to live independently and be included in the community were identified., Conclusions: This study identifies shortcomings and critical areas that the Ghanaian government and facilities need to target for implementing a human rights-based approach in mental health and improve the quality of mental health care throughout the country., (© 2022. The Author(s).)

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., (© 2022. The Author(s).)

Background: As the number of people living with dementia grows, so does the need to provide them with adequate psychosocial support. Many people with dementia live at home with family carers, who also require social and emotional support to cope with their role. Community group singing has received attention for its potential to support people with dementia and their carers. It is postulated that singing can improve cognitive function, strengthen the bonds between care partners and help to establish social support networks. However, there is a lack of rigorous evidence of singing's benefits for this population. This study aims to test the feasibility of a randomised controlled trial of community singing in dementia, to pave the way for a larger, conclusive study., Methods: The PRESIDE study is designed as a two-arm, parallel-group randomised trial with a waiting list control. Dyads consisting of a person with dementia (n = 80) and their carer (n = 80) will be recruited. Each dyad will be randomised either to attend 10 weeks of community group singing sessions straight away or to wait for 3 months before attending the sessions. The singing sessions will be led by experienced professional musicians and will last about 90 min, including time for socialising. The primary outcome of this study is the attainment of feasibility criteria around recruitment, retention and the acceptability of the waiting list control. Secondary outcomes include the quality of life, mood, cognition, and musical engagement of the person with dementia, and quality of life, mood, and experiences/challenges of the carer. These data will be collected during home visits at baseline, and 3 and 6 months post-baseline., Discussion: Despite growing public interest in the positive effects of singing, and encouraging findings from qualitative and non-randomised quantitative studies, there is a lack of rigorous evidence. This is the first randomised controlled trial of community group singing for people with dementia in Europe, to our knowledge. If the results favour a full trial, conclusively demonstrating the effectiveness of group singing could positively affect the opportunities available to community-dwelling people with dementia and their carers., Trial Registration: Unique identification number in ISRCTN registry: ISRCTN10201482 . Date registered: 12 May 2020.

Background: Teams delivering crisis resolution services for people with dementia and their carers provide short-term interventions to prevent admission to acute care settings. There is great variation in these services across the UK. This article reports on a consensus process undertaken to devise a Best Practice Model and evaluation Tool for use with teams managing crisis in dementia., Methods: The Best Practice Model and Tool were developed over a three stage process: (i) Evidence gathering and generation of candidate standards (systematic review and scoping survey, interviews and focus groups); (ii) Prioritisation and selection of standards (consultation groups, a consensus conference and modified Delphi process); (iii) Refining and operationalising standards (consultation group and field-testing)., Results: One hundred sixty-five candidate standards arose from the evidence gathering stage; were refined and reduced to 90 through a consultation group exercise; and then reduced to 50 during the consensus conference and weighted using a modified Delphi process. Standards were then operationalised through a clinical consultation group and field-tested with 11 crisis teams and 5 non-crisis teams. Scores ranged from 48 to 92/100. The median score for the crisis teams was 74.5 (range 67-92), and the median score for non-crisis teams was 60 (range 48-72)., Conclusions: With further psychometric testing, this Best Practice Model and Tool will be ideal for the planning, improvement and national benchmarking of teams managing dementia crises in the future.

Background: Interpreting data about intervention effectiveness requires an understanding of which intervention components were delivered and whether they were delivered as planned (fidelity of delivery). These studies aimed to develop a reliable measure for assessing fidelity of delivery of the Community Occupational Therapy in Dementia-UK intervention (COTiD-UK) (Study 1) and measure fidelity of delivery of COTiD-UK across sessions, sites and occupational therapists (Study 2)., Methods: The studies used a longitudinal observational design nested within a multi-site randomised controlled trial. Where practicable, all intervention sessions were audio-recorded. Fidelity checklists and coding guidelines were developed, piloted and refined until good agreement was achieved between two coders. Ten percent of sessions were purposively sampled from 12 sites and 31 occupational therapists. Transcripts were coded using checklists developed in Study 1; 10% of sets of intervention session transcripts were double coded to ensure that agreement was maintained. Percentages of components that were delivered were calculated for each session, site and occupational therapist., Results: A reliable measure of fidelity of delivery for COTiD-UK was developed after several rounds of piloting and amendments. COTiD-UK was delivered with moderate fidelity across all six sessions (range: 52.4-75.5%). The mean range of fidelity varied across sites (26.7-91.2%) and occupational therapists (26.7-94.1%)., Conclusions: A reliable, systematic method for measuring fidelity of delivery of COTiD-UK was developed and applied, and can be adapted for use in similar interventions. As COTiD-UK was delivered with moderate fidelity, there is a reasonable degree of confidence that intervention effects were attributable to COTiD-UK.

Background: Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone., Methods/design: PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month's post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined., Discussion: This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial., Trial Registration: ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

Background: Modifying lifestyle risk factors for dementia is a public health priority. Motivation for change is integral to the modification of health-related risk behaviours. This study investigates the psychometric properties of the previously validated tool entitled 'Motivation to Change Lifestyle and Health Behaviours for Dementia Risk Reduction Scale' (MCLHB-DRR) for use in the UK., Methods: A sample of 3,948 individuals aged 50 and over completed the 27-item MCLHB-DRR online. The psychometric properties of the scale were explored via Exploratory Principal Axis Factoring (PAF) with Oblimin rotation. Confirmatory Factor Analysis (CFA) was used to confirm the factor structure using chi-square (χ2), the goodness-of-fit index (GFI), the comparative fit index (CFI), the root mean square error of approximation (RMSEA) and Root Mean Square Residual (RMR) as fit indices to evaluate the model fit. Internal consistency (Cronbach α) was measured for the final scale version., Results: Exploratory Factor Analysis (EFA) resulted in a parsimonious 10-item, two-factor structure (5 items each, factor loadings > 0.3) that explained 52.83% of total variance. Based on the Pattern Matrix, Factor 1 was labelled "Positive Cues to Action" and Factor 2 was labelled "Negative Cues to Action". After addressing some errors in covariances, CFA showed a good fit where all fit indices were larger than 0.90 (GFI = 0.968, CFI = 0.938) and smaller than 0.08 (RMSEA = 0.072, RMR = 0.041). The standardized coefficients of Factor 1 and Factor 2 ranged from 0.30 to 0.73 and were all statistically significant (p < 0.001). The final scale showed moderate to high reliability scores (Factor 1 α = 0.809; Factor 2 α = 0.701; Overall α = 0.785)., Conclusions: The new MOCHAD-10 (Motivation to Change Behaviour for Dementia Risk Reduction Scale) is a short, reliable and robust two-factor, 10-item clinical tool for use in preventative health care and research to evaluate motivation to change lifestyle for dementia risk reduction.

Background: Family caregivers of people living with dementia can experience feelings of burden and stress but the concept of sense of coherence has been identified as an important protective trait against the negative impact of caregiving. Despite this, there has been no psychometric evaluation of the Sense of Coherence scale-13 with this population. Therefore, a psychometric evaluation was conducted using a mixed-methods approach., Method: Five hundred and eighty-three caregivers of people living with dementia participated in the study. We examined the feasibility, internal consistency, construct validity, floor and ceiling effects, concurrent validity and face validity of the Sense of Coherence scale-13., Results: The Sense of Coherence scale-13 demonstrated adequate internal consistency. Sense of coherence was positively related to resilience, sense of competence and health related quality of life, demonstrating good concurrent validity. However, the face validity of the scale was assessed as poor., Conclusion: The sense of coherence scale performed well under psychometric evaluation however guidance for caregivers should be examined and revised to reflect feedback from caregivers who completed this study, which could lead to improved face validity for this scale., Trial Registration Number: ISRCTN10748953 . Registered 18th September 2014.

Background: There is a growing need for an evidence-based approach to home support for people with dementia and their carers following diagnosis but research on the effectiveness and cost-effectiveness of different approaches is sparse. The Dementia Early Stage Cognitive Aids New Trial (DESCANT) will evaluate the clinical and cost-effectiveness of a range of memory aids, training and support to people with mild to moderate dementia and their carers at home and compares that intervention with treatment as usual., Methods/design: This is a multi-site, pragmatic randomised trial preceded by a feasibility study and internal pilot. We aim to allocate at random 360 pairs comprising a person with mild to moderate dementia and an identified carer between the DESCANT intervention and treatment as usual. We assess participants at baseline, 13 and 26 weeks. The primary outcome measure is the Bristol Activities of Daily Living Scale; other participant outcomes include cognition, quality of life, activities of daily living and social networking; carer outcomes include quality of life, sense of competence and mental health. To enhance this quantitative evaluation we are conducting a qualitative component and a process evaluation to assess the implementation process and identify contextual factors associated with variation., Discussion: The DESCANT intervention reflects current policy to enhance the capabilities of people with dementia after diagnosis and their carers. If it is clinically and cost-effective, its modest nature and cost will enhance the likelihood of it being incorporated into mainstream practice., Trial Registration: Current Controlled Trials, ISRCTN12591717 . Registered on 29 July 2016. Protocol number: 31288: North West - Haydock Research Ethics Committee, 20/06/2016, ref.: 16/NW/0389.

Background: People with dementia progressively lose abilities and are prone to falling. Exercise- and activity-based interventions hold the prospect of increasing abilities, reducing falls, and slowing decline in cognition. Current falls prevention approaches are poorly suited to people with dementia, however, and are of uncertain effectiveness. We used multiple sources, and a co-production approach, to develop a new intervention, which we will evaluate in a feasibility randomised controlled trial (RCT), with embedded adherence, process and economic analyses., Methods: We will recruit people with mild cognitive impairment or mild dementia from memory assessment clinics, and a family member or carer. We will randomise participants between a therapy programme with high intensity supervision over 12 months, a therapy programme with moderate intensity supervision over 3 months, and brief falls assessment and advice as a control intervention. The therapy programmes will be delivered at home by mental health specialist therapists and therapy assistants. We will measure activities of daily living, falls and a battery of intermediate and distal health status outcomes, including activity, balance, cognition, mood and quality of life. The main aim is to test recruitment and retention, intervention delivery, data collection and other trial processes in advance of a planned definitive RCT. We will also study motivation and adherence, and conduct a process evaluation to help understand why results occurred using mixed methods, including a qualitative interview study and scales measuring psychological, motivation and communication variables. We will undertake an economic study, including modelling of future impact and cost to end-of-life, and a social return on investment analysis., Discussion: In this study, we aim to better understand the practicalities of both intervention and research delivery, and to generate substantial new knowledge on motivation, adherence and the approach to economic analysis. This will enable us to refine a novel intervention to promote activity and safety after a diagnosis of dementia, which will be evaluated in a definitive randomised controlled trial., Trial Registration: ClinicalTrials.gov: NCT02874300; ISRCTN 10550694., Competing Interests: This protocol was approved by the Bradford Leeds Research Ethics Committee (reference 16/YH/0040). All participants give written informed consent.Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Background: As part of the ActifCare (ACcess to Timely Formal Care) project, we conducted expert interviews in eight European countries with policy and political decision makers, or representatives of relevant institutions, to determine their perspectives on access to formal care for people with dementia and their carers., Methods: Each ActifCare country (Germany, Ireland, Italy, The Netherlands, Norway, Portugal, Sweden, United Kingdom) conducted semi-structured interviews with 4-7 experts (total N = 38). The interview guide addressed the topics "Complexity and Continuity of Care", "Formal Services", and "Public Awareness". Country-specific analysis of interview transcripts used an inductive qualitative content analysis. Cross-national synthesis focused on similarities in themes across the ActifCare countries., Results: The analysis revealed ten common themes and two additional sub-themes across countries. Among others, the experts highlighted the need for a coordinating role and the necessity of information to address issues of complexity and continuity of care, demanded person-centred, tailored, and multidisciplinary formal services, and referred to education, mass media and campaigns as means to raise public awareness., Conclusions: Policy and political decision makers appear well acquainted with current discussions among both researchers and practitioners of possible approaches to improve access to dementia care. Experts described pragmatic, realistic strategies to influence dementia care. Suggested innovations concerned how to achieve improved dementia care, rather than transforming the nature of the services provided. Knowledge gained in these expert interviews may be useful to national decision makers when they consider reshaping the organisation of dementia care, and may thus help to develop best-practice strategies and recommendations.

Background: Positive psychology research in dementia care has largely been confined to the qualitative literature because of the lack of robust outcome measures. The aim of this study was to develop positive psychology outcome measures for people with dementia., Methods: Two measures were each developed in four stages. Firstly, literature reviews were conducted to identify and operationalise salient positive psychology themes in the qualitative literature and to examine existing measures of positive psychology. Secondly, themes were discussed within a qualitative study to add content validity for identified concepts (n = 17). Thirdly, draft measures were submitted to a panel of experts for feedback (n = 6). Finally, measures were used in a small-scale pilot study (n = 33) to establish psychometric properties., Results: Salient positive psychology themes were identified as hope, resilience, a sense of independence and social engagement. Existing measures of hope and resilience were adapted to form the Positive Psychology Outcome Measure (PPOM). Due to the inter-relatedness of independence and engagement for people with dementia, 28 items were developed for a new scale of Engagement and Independence in Dementia Questionnaire (EID-Q) following extensive qualitative work. Both measures demonstrated acceptable internal consistency (α = .849 and α = .907 respectively) and convergent validity., Conclusions: Two new positive psychology outcome measures were developed using a robust four-stage procedure. Preliminary psychometric data was adequate and the measures were easy to use, and acceptable for people with dementia.

Background: Research reporting results of clinical trials, psychosocial or technological interventions frequently omit critical details needed to inform implementation in practice. The aim of this article is to develop an Implementation Readiness (ImpRess) checklist, that includes criteria deemed useful in measuring readiness for implementation and apply it to trials of cognitive stimulation in dementia, providing a systematic review of their readiness for widespread implementation., Methods: Five electronic databases were searched. After initial screening of papers, two reviewers assessed quality and scored the included studies based on the ImpRess checklist specifically developed for this review., Results: Twenty studies met the inclusion criteria. As determined by the ImpRess checklist, scores ranged from 11 to 29 out of 52. According to the checklist the most comprehensive and ready to implement version of cognitive stimulation was Cognitive Stimulation Therapy., Conclusions: Reports of interventions rarely include consideration of implementation in practice. Contrary to the growing number of reporting guidelines, crucial items within the ImpRess checklist have been frequently overlooked. This study was able to show that the ImpRess checklist was feasible in practice and reliable. The checklist may be useful in evaluating readiness for implementation for other manualised interventions.

Background: Previous findings indicate that people with dementia and their informal carers experience difficulties accessing and using formal care services due to a mismatch between needs and service use. This mismatch causes overall dissatisfaction and is a waste of the scarce financial care resources. This article presents the background and methods of the Actifcare (ACcess to Timely Formal Care) project. This is a European study aiming at best-practice development in finding timely access to formal care for community-dwelling people with dementia and their informal carers. There are five main objectives: 1) Explore predisposing and enabling factors associated with the use of formal care, 2) Explore the association between the use of formal care, needs and quality of life and 3) Compare these across European countries, 4) Understand the costs and consequences of formal care services utilization in people with unmet needs, 5) Determine the major costs and quality of life drivers and their relationship with formal care services across European countries., Methods: In a longitudinal cohort study conducted in eight European countries approximately 450 people with dementia and informal carers will be assessed three times in 1 year (baseline, 6 and 12 months). In this year we will closely monitor the process of finding access to formal care. Data on service use, quality of life and needs will be collected., Discussion: The results of Actifcare are expected to reveal best-practices in organizing formal care. Knowledge about enabling and predisposing factors regarding access to care services, as well as its costs and consequences, can advance the state of the art in health systems research into pathways to dementia care, in order to benefit people with dementia and their informal carers.

Background: Cognitive Stimulation Therapy (CST) groups for people with dementia are available nationally, and internationally through voluntary organisations, memory services, and in residential care settings. However, groups may not be accessible or best suited for all. Individual Cognitive Stimulation Therapy (iCST) has been developed to provide another means of accessing CST., Methods: The programme was field tested by 22 dyads (carers and people with dementia). Dyads were trained in the iCST approach and provided with a manual and accompanying resources. Researchers contacted dyads weekly to provide support and gather adherence data. Quantitative feedback about each session was also collected using 'Monitoring Progress' forms. Upon completion of their allocation sessions, researchers interviewed dyads about their experience. In total, nine dyads were followed up. Inductive thematic analysis was performed on the qualitative data. The aims of field testing were to assess the feasibility of the programme, and the appropriateness of the iCST materials., Results: Sixty-two percent of the themes received an overall 'high' rating, and the majority of activities were classed as 'low' difficulty. Common barriers to completing sessions were; lack of time, illness, and motivation. Carers felt the manual and resources were 'good' and easy to use. Benefits of the programme for the person included; improvements in communication, mood, and alertness. The programme also gave carers insight into the person's abilities and interests, and provided a new channel of communication. Little support was needed to deliver the programme., Conclusions: Implementation of the iCST intervention was feasible. However, the majority of dyads completed fewer than three sessions per week. The training and support package appeared to be suitable as carers were able to deliver the intervention without intensive support. Barriers occurred largely as a result of life commitments, rather than problems with the intervention itself. This study was limited by a high loss to follow up rate. The effectiveness and cost effectiveness of iCST were investigated in a large scale randomised controlled trial (RCT)., Trial Registration: ISRCTN65945963 Date of trial registration: 05/05/2010.

Background: A community-based occupational therapy intervention for people with mild to moderate dementia and their family carers (Community Occupational Therapy in Dementia (COTiD)) was found clinically and cost effective in the Netherlands but not in Germany. This highlights the need to adapt and implement complex interventions to specific national contexts. The current trial aims to evaluate the United Kingdom-adapted occupational therapy intervention for people with mild to moderate dementia and their family carers living in the community (COTiD-UK) compared with treatment as usual., Methods/design: This study is a multi-centre, parallel-group, pragmatic randomised trial with internal pilot. We aim to allocate 480 pairs, with each pair comprising a person with mild to moderate dementia and a family carer, who provides at least 4 hours of practical support per week, at random between COTiD-UK and treatment as usual. We shall assess participants at baseline, 12 and 26 weeks, and by telephone at 52 and 78 weeks (first 40% of recruits only) after randomisation. The primary outcome measure is the Bristol Activities of Daily Living Scale (BADLS) at 26 weeks. Secondary outcome measures will include quality of life, mood, and resource use. To assess intervention delivery, and client experience, we shall collect qualitative data via audio recordings of COTiD-UK sessions and conduct semi-structured interviews with pairs and occupational therapists., Discussion: COTiD-UK is an evidence-based person-centred intervention that reflects the current priority to enable people with dementia to remain in their own homes by improving their capabilities whilst reducing carer burden. If COTiD-UK is clinically and cost effective, this has major implications for the future delivery of dementia services across the UK., Trial Registration: Current Controlled Trials ISRCTN10748953 Date of registration: 18 September 2014.

Background: Individual Cognitive Stimulation Therapy (iCST) is a one to one, carer led psychosocial intervention for people with dementia, adapted from group Cognitive Stimulation Therapy (CST). It is increasingly recognised that involving service users in research is key to developing interventions and treatments that successfully address their needs. This study describes the contribution of people with dementia and carers during the development phase of the intervention and materials., Methods: Twenty-eight people with dementia and 24 carers were consulted in a series of six focus groups and 10 interviews. The purpose of this study was to gain insight into perceptions of mental stimulation from the point of view of carers and people with dementia, to ensure the materials are easy to use, clear, and appropriately tailored to the needs of people with dementia and their carers, and to assess the feasibility of the intervention., Results: The importance of mental stimulation was emphasized by carers and people with dementia. People with dementia saw activities as a way of 'keeping up to date' and spending time in a meaningful way. Carers reported benefits such as improved quality of life, mood and memory. The concept of iCST was well received, and both carers and people with dementia responded positively to the first drafts of materials. Feasibility issues, such as finding time to do sessions, were identified., Conclusion: The feedback from the focus groups and interviews will be used to further develop and refine the iCST programme materials in preparation for a field testing phase prior to a large scale randomized controlled trial (RCT)., Trial Registration: ISRCTN65945963. Date of registration: 05/05/2010.

Background: People with dementia living in care homes often have complex mental health problems, disabilities and social needs. Providing more comprehensive training for staff working in care home environments is a high national priority. It is important that this training is evidence based and delivers improvement for people with dementia residing in these environments. Well-being and Health for People with Dementia (WHELD) combines the most effective elements of existing approaches to develop a comprehensive but practical staff training intervention. This optimised intervention is based on a factorial study and qualitative evaluation, to combine: training on person-centred care, promoting person-centred activities and interactions, and providing care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes., Design: The trial will be a randomised controlled two-arm cluster single blind trial that will take place for nine months across 80 care homes in the United Kingdom., Discussion: The overarching goal of this trial is to determine whether this optimised WHELD intervention is more effective in improving the quality of life and mental health than the usual care provided to people with dementia living in nursing homes. This study will be the largest and best powered randomised controlled trial (RCT) evaluating the benefits of an augmented person-centred care training intervention in care homes worldwide., Trial Registration: Current controlled trials ISRCTN62237498 Date registered: 5 September 2013.

Background: There is growing evidence that Cognitive Simulation Therapy (CST) benefits cognition and quality of life of people with dementia, but little is known about the indirect effects of this intervention on family caregivers. This study sought to investigate the effect of CST on family caregivers general health status of people with dementia living in the community attending the CST intervention., Method: Eighty-five family caregivers of people with dementia took part in the study. All the people with dementia received the standard twice weekly seven weeks of the CST intervention plus either 24 weeks of a maintenance CST (MCST) intervention or 24 weeks of treatment as usual. Family caregivers were assessed before and after their relatives the CST programme, and after 3 and 6 months of the MCST programme. A pre and post CST groups comparison was undertaken to evaluate the open trial first phase and an ANCOVA model used to analyse the maintenance phase with its controlled comparison., Results: We found no evidence for a benefit on the family caregiver outcome measures of the intervention before and after CST groups by using a t-test analysis or any significant differences between intervention and control groups for any of the variables considered at any time point (3 and 6 month follow up)., Conclusion: CST seems to have a relatively specific benefit fpr people with dementia that may not carry over to family carers. Future studies need to further explore and compare the effects that CST might bring to family caregivers of people with dementia attending the intervention., Trial Registration: Current Controlled Trials ISRCTN26286067.

Conducting a pilot trial is important in preparing for, and justifying investment in, the ensuing larger trial. Pilot trials using the same design and methods as the subsequent main trial are ethically and financially advantageous especially when pilot and main trial data can be pooled. For explanatory trials in which internal validity is paramount, there is little room for variation of methods between the pilot and main trial. For pragmatic trials, where generalisability or external validity is key, greater flexibility is written into trial protocols to allow for 'real life' variation in procedures. We describe the development of a checklist for use in decision-making on whether pilot data can be carried forward to the main trial dataset without compromising trial integrity. We illustrate the use of the checklist using a pragmatic trial of psychosocial interventions for family carers of people with dementia as a case study.

Background: Few reports have been published about differences in perspectives on perceived needs among community-residing people with dementia, their family caregivers, and professionals. The aim of this study was to compare these perspectives., Method: During 2006 and 2007, one-hundred and fifty two interviews of people with dementia and their caregivers about the needs of the person with dementia were performed by four professionals using The Camberwell Assessment of Need for the Elderly (CANE). Professionals' views on met and unmet needs of people with dementia were obtained for the total sample, family caregivers' perspectives were gained for 125 people with dementia, and people with dementia's views on their own needs were obtained for 125 persons with dementia., Results: People with dementia reported fewer needs compared with the reports of their caregivers and the professionals. The most frequent unmet needs reported by people with dementia, caregivers and professionals were in the areas of daytime activities, company, and psychological distress; however, people with dementia rated psychological distress as the commonest unmet need., Conclusions: Since the priorities of people with dementia can be different from those of caregivers and professionals, it is important to consider all perspectives when making care plans. Thus, compliance with treatment of people with dementia and also their quality of life could be potentially improved by a more collaborative partnership with them.

Background: People living in care homes often have complex mental and physical health problems, disabilities and social needs which are compounded by the use of psychiatric and other drugs. In the UK dementia care is a national priority with a vast impact on services. WHELD combines the most effective elements of existing approaches to develop a comprehensive but practical intervention. This will be achieved by training care staff to provide care that is focused on an understanding of the individual and their needs; and by using additional components such as exercise, activities and social interaction to improve mental health and quality of life (QoL) and reduce the use of sedative drugs., Design: Work Package 3 (WP3) is the pilot randomised trial and qualitative evaluation to help develop a future definitive randomised controlled clinical trial. The study design is a cluster randomised 2x2x2 factorial design with two replications in 16 care homes. Each care home is randomized to receive one of the eight possible permutations of the four key interventions, with each possible combination delivered in two of the 16 homes. Each cluster includes a minimum of 12 participants (depending upon size of the care home, the number of people with dementia and the number consenting)., Discussion: The overarching goal of the programme is to provide an effective, simple and practical intervention which improves the mental health of, and reduces sedative drug use in, people with dementia in care homes and which can be implemented nationally in all UK care homes as an NHS intervention., Trial Registration: Current controlled trials ISRCTN40313497.

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.

Background: Improving the quality of care for people with dementia and their carers has become a national priority in many countries. Cognitive Stimulation Therapy (CST) groups can be beneficial in improving cognition and quality of life for people with dementia. The aim of the current study is to develop and evaluate a home-based individual Cognitive Stimulation Therapy (iCST) programme for people with dementia which can be delivered by their family carer., Methods: This multi-centre, pragmatic randomised controlled trial (RCT) will compare the effectiveness and cost-effectiveness of iCST for people with dementia with a treatment as usual control group. The intervention consists of iCST sessions delivered by a carer for 30 minutes, 3 times a week over 25 weeks.For people with dementia the primary outcome measures are cognition assessed by the ADAS-Cog, and quality of life assessed by QoL-AD. For carers, quality of life using the SF-12 is the primary outcome measure. Using a 5% significance level, comparison of 306 participants will yield 80% power to detect an effect size of 0.35 for cognition as measured by the ADAS-Cog, and quality of life as measured by the QoL-AD. Quality of life for the carer will be measured using the SF-12. The trial will include a cost-effectiveness analysis from a public sector perspective., Discussion: The UK Department of Health has recently stressed that improving access to psychological therapies is a national priority, but many people with dementia are unable to access psychological interventions. The development of a home-based individual version of CST will provide an easy to use, widely available therapy package that will be evaluated for effectiveness and cost-effectiveness in a multi centre RCT.

Background: Cognitive Stimulation Therapy (CST) is a psychosocial evidence-based group intervention for people with dementia recommended by the UK NICE guidelines. In clinical trials, CST has been shown to improve cognition and quality of life, but little is known about the best way of ensuring implementation of CST in practice settings. A recent pilot study found that a third of people who attend CST training go on to run CST in practice, but staff identified a lack of support as a key reason for the lack of implementation., Methods/design: There are three projects in this study: The first is a pragmatic multi-centre, randomised controlled trial (RCT) of staff training, comparing CST training and outreach support with CST training only; the second, the monitoring and outreach trial, is a phase IV trial that evaluates implementation of CST in practice by staff members who have previously had the CST manual or attended training. Centres will be randomised to receive outreach support. The primary outcome measure for both of these trials is the number of CST sessions run for people with dementia. Secondary outcomes include the number of attenders at sessions, job satisfaction, dementia knowledge and attitudes, competency, barriers to change, approach to learning and a controllability of beliefs and the level of adherence. Focus groups will assess staff members' perceptions of running CST groups and receiving outreach support. The third study involves monitoring centres running groups in their usual practice and looking at basic outcomes of cognition and quality of life for the person with dementia., Discussion: These studies assess the effects of outreach support on putting CST into practice and running groups effectively in a variety of care settings with people with dementia; evaluate the effectiveness of CST in standard clinical practice; and identify key factors promoting or impeding the successful running of groups., Trial Registration: Clinical trial ISRCTN28793457.

Background: Peer support interventions can improve carer wellbeing and interventions that engage both the carer and person with dementia can have significant mutual benefits. Existing research has been criticised for inadequate rigour of design or reporting. This paper describes the protocol for a complex trial that evaluates one-to-one peer support and a group reminiscence programme, both separately and together, in a factorial design., Design: A 2 × 2 factorial multi-site randomised controlled trial of individual peer support and group reminiscence interventions for family carers and people with dementia in community settings in England, addressing both effectiveness and cost-effectiveness., Discussion: The methods described in this protocol have implications for research into psychosocial interventions, particularly complex interventions seeking to test both individual and group approaches.

Background: There is lack of evidence about the unmet needs of people with dementia (PWD) living at home and the predictors of high levels of unmet needs. The main aim of this study was to identify the relationship between unmet needs, social networks and quality of life of PWD living at home., Methods: One hundred and fifty two community dwelling PWD and 128 carers were interviewed about PWD's needs, social networks, quality of life and other functional and psychological factors. All the interviews with PWD were carried out at their homes. Interviews with carers were undertaken either at PWD's home, their own home or at the health centre. Whenever possible, PWD and carers were interviewed separately. The data collection took place between November 2005 and July 2007. The majority of participants (129, 84.9%) were recruited from National Health Services (NHS) and the rest (23, 15.1%) were recruited from other organisations such as social services and voluntary organizations in the UK., Results: The most frequent unmet needs for PWD were daytime activities (77, 50.7%), company (60, 39.5%), and help with psychological distress (47, 30.9%). Higher number of behavioural and psychological symptoms, low-community involvement social networks, having a younger carer and higher carer's anxiety were found to be predictors of higher unmet needs in PWD. Social networks and behavioural and psychological symptoms had an indirect effect on PWD's self-rated quality of life through unmet needs., Conclusions: Interventions aiming to reduce unmet needs, through the treatment of behavioural and psychological symptoms and the involvement of PWD in the community, would potentially improve PWD's quality of life.

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.

Background: The growing number of people with dementia, and the increasing cost of care, provides a major incentive to develop and test methods of supporting them in the community for longer. Most attention has been given to pharmacological interventions, but there is increasing recognition that psychosocial interventions may be equally effective, even preferable where medication has negative side-effects. Reminiscence groups, run by professionals and volunteers, which use photographs, recordings and other objects to trigger personal memories are probably the most popular therapeutic approach to working with people with dementia, but there is little evidence for their effectiveness and cost-effectiveness. The recent inclusion of family carers in groups with people with dementia, notably in our own pilot studies, has generated informal evidence that this joint approach improves relationships between people with dementia and their carers, and benefits both., Design and Methods: This multi-centre, pragmatic randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of joint reminiscence groups for people with dementia and their family care-givers has two parallel arms--an intervention group and a control group who receive care as usual. The intervention consists of joint reminiscence groups held weekly for twelve consecutive weeks, followed by monthly maintenance sessions for a further seven months.The primary outcome measures are the quality of life of people with dementia, as assessed by QoL-AD, and their care-givers' mental health as assessed by the GHQ-28. Secondary outcomes include: the autobiographical memories of people with dementia; the quality of the relationship between them and their care-givers; and the levels of depression and anxiety felt by them and their care-giver. Using a 5% significance level, comparison of 200 pairs attending joint reminiscence groups with 200 pairs receiving usual treatment will yield 80% power to detect a standardised difference of 0.38 in the QoL-AD rated by the person with dementia and 0.28 in the GHQ-28 or carer-rated QoL-AD. The trial will include a cost-effectiveness analysis from a public sector perspective., Discussion: Our Cochrane review (2005) on reminiscence therapy for people with dementia did not identify any rigorous trials or economic analyses in this field., Trial Registration: ISRCTN42430123.