The memory clinic and psychosocial intervention: Translating past promise into current practices.

Disproportionate negative effects since the pandemic have amplified the already limited post-diagnostic support for older people with dementia. This paper summarizes an exploratory randomized controlled study of a proactive family-based intervention compared with "usual" post-diagnostic dementia care. Memory clinic practitioners collaborated with the family doctor (GP) to coordinate this. At 12-month follow-up, positive effects on mood, behavior, carer coping and maintenance of care at home were found. Current approaches to deliver post-diagnostic support in primary care may require rethinking since (i) GP workloads have increased with low numbers of GPs per head of population in parts of England; and (ii) unlike many other long-term conditions, ongoing stigma, fear and uncertainty associated with dementia adds to the huge complexity of timely care provision. There is a case for return to a "one-stop facility", with a single pathway of continuing multidisciplinary coordinated care for older people with dementia and families. Future longitudinal research could compare structured post-diagnostic psychosocial intervention coordinated by skilled practitioners in a single locality memory service "hub", against other approaches such support organized mostly within primary care. Dementia-specific instruments for outcome measurement are available for use in routine practice, and should be included in such comparative studies.

What is intended by the term "participation" and what does it mean to people living with dementia? A conceptual overview and directions for future research.

Policy continues to emphasise the importance of wellbeing in dementia. However, there is a vital need for psychosocial interventions that can promote positive outcomes to enhance "living well with dementia". Our developing understanding of what people living with dementia report as being important to them, has resulted in new interpretations of what constitutes wellbeing including constructs such as "growth", "purpose" and "participation". These exciting and important constructs are not currently captured by outcome measures within dementia research. This limits our understanding of the value of psychosocial interventions. This paper explores the concept of participation and how continued participation in social life can make a difference to the rights of people living with dementia as citizens. We will firstly consider why participation is important for how we might measure outcomes in dementia research and care. Secondly, we will explore how we might measure participation. Finally, we will consider the value of participation as a psychosocial outcome in future research.

The Journeying through Dementia psychosocial intervention versus usual care study: a single-blind, parallel group, phase 3 trial.

BACKGROUND: There is an urgent clinical need for evidence-based psychosocial interventions for people with mild dementia. We aimed to determine the clinical benefits and cost-effectiveness of Journeying through Dementia (JtD), an intervention designed to promote wellbeing and independence in people with mild dementia. METHODS: We did a single-blind, parallel group, individually randomised, phase 3 trial at 13 National Health Service sites across England. People with mild dementia (Mini-Mental State Examination score of ≥18) who lived in the community were eligible for inclusion. Patients were centrally randomly assigned (1:1) to receive the JtD intervention plus standard care (JtD group) or standard care only (standard care group). Randomisation was stratified by study site. The JtD intervention included 12 group and four one-to-one sessions, delivered in the community at each site. The primary endpoint was Dementia Related Quality of Life (DEMQOL) 8 months after randomisation, assessed according to the intention-to-treat principle. Only outcome assessors were masked to group assignment. A cost-effectiveness analysis reported cost per quality-adjusted life-year (QALY) from a UK NHS and social care perspective. The study is registered with ISRCTN, ISRCTN17993825. FINDINGS: Between Nov 30, 2016, and Aug 31, 2018, 1183 patients were screened for inclusion, of whom 480 (41%) participants were randomly assigned: 241 (50%) to the JtD group and 239 (50%) to the standard care group. Intervention adherence was very good: 165 (68%) of 241 participants in the JtD group attended at least ten of the 16 sessions. Mean DEMQOL scores at 8 months were 93·3 (SD 13·0) for the JtD group and 91·9 (SD 14·6) for the control group. Difference in means was 0·9 (95% CI -1·2 to 3·0; p=0·38) after adjustment for covariates, lower than that identified as clinically meaningful. Incremental cost per QALY ranged from £88 000 to -£205 000, suggesting that JtD was not cost-effective. Unrelated serious adverse events were reported by 40 (17%) patients in the JtD group and 35 (15%) patients in the standard care group. INTERPRETATION: In common with other studies, the JtD intervention was not proven effective. However, this complex trial successfully recruited and retained people with dementia without necessarily involving carers. Additionally, people with dementia were actively involved as participants and study advisers throughout. More research into methods of measuring small, meaningful changes in this population is needed. Questions remain regarding how services can match the complex, diverse, and individual needs of people with mild dementia, and how interventions to meet such needs can be delivered at scale. FUNDING: UK National Institute of Health Research Health Technology Assessment Programme.

Person-centered assessment of apathy and resistance to care in people living with dementia: Review of existing measures.

Introduction: The review described in this paper builds upon the Dementia Care Practice Recommendations (DCPR) published by the Alzheimer's Association in 2018 and addresses behavior change and the need for targeted outcome measures that evolve from person-centered frameworks and help evaluate interventions. Apathy and resistance to care (RTC) are two specific behavioral expressions of unmet need or distress exhibited by people living with dementia, which are upsetting to formal and family caregivers and compromise quality of life for people living with dementia. Methods: We conducted literature searches of major databases (PsycInfo, PubMed, EBSCO, CINAHL) for papers examining apathy and RTC constructs in samples of people living with dementia. Reliability and validity coefficients were reviewed and reported, along with examination of whether each measure facilitates contextual understanding of behavior. Results: Three stand-alone measures of RTC and ten measures of apathy were identified and reviewed. The RTC measures demonstrated good psychometric properties but do not include the perspective of the person living with dementia or contextual aspects of the behavior. The identified apathy measures demonstrated fair to good psychometric properties, and although there is greater consideration of context, none adequately include the perspective of the person living with dementia. Discussion: Although reliable and valid measures have been developed to measure apathy and RTC in people living with dementia, there is greater need for conceptually driven measurement of behavior context and for tools that elicit and include the perspective of the person living with dementia.

Embedding patient and public involvement in dementia research: Reflections from experiences during the 'Journeying through Dementia' randomised controlled trial.

BACKGROUND: The involvement of people with a diagnosis of dementia in patient and public involvement and engagement (PPIE) in research is an emerging field in the delivery of studies. Researchers need to understand and use the learning derived from various projects so that this growing body of knowledge can be applied in future research. OBJECTIVE: To embed PPIE throughout a randomised controlled trial of a psychosocial intervention called Journeying through Dementia. We identify and discuss the approaches to involvement that worked well and those where improvements were indicated. DESIGN: The Guidance for Reporting Involvement of Patients and the Public Short Form (GRIPP2-SF) is used to describe and critically appraise the approaches taken and the impact of PPIE involvement upon study processes, the study team and those people with dementia and their supporters who acted as advisors. FINDINGS: The involvement of people with a diagnosis of dementia and supporters as study advisors improved the accessibility and relevance of the research for people living with dementia. It also highlighted issues that researchers may have otherwise overlooked. Successful engagement of people with dementia and their supporters in the study was associated with staff skills and particularly use of techniques to scaffold meaningful involvement, as well as participants' memory and cognitive capacity. However, embedding robust and meaningful involvement processes required significant time and resources. DISCUSSION: We propose that certain research processes need to be adapted to be accessible and appropriate for people living with dementia. Recruitment of PPIE advisors needs to reflect population diversity. There also needs to be greater parity of voice between people with lived experience of dementia and researchers. These steps will increase the impact of PPIE in research and improve the experience for those who volunteer to be PPIE advisors.

An intervention to promote self-management, independence and self-efficacy in people with early-stage dementia: the Journeying through Dementia RCT.

BACKGROUND: There are few effective interventions for dementia. AIM: To determine the clinical effectiveness and cost-effectiveness of an intervention to promote self-management, independence and self-efficacy in people with early-stage dementia. OBJECTIVES: To undertake a randomised controlled trial of the Journeying through Dementia intervention compared with usual care, conduct an internal pilot testing feasibility, assess intervention delivery fidelity and undertake a qualitative exploration of participants' experiences. DESIGN: A pragmatic two-arm individually randomised trial analysed by intention to treat. PARTICIPANTS: A total of 480 people diagnosed with mild dementia, with capacity to make informed decisions, living in the community and not participating in other studies, and 350 supporters whom they identified, from 13 locations in England, took part. INTERVENTION: Those randomised to the Journeying through Dementia intervention (n = 241) were invited to take part in 12 weekly facilitated groups and four one-to-one sessions delivered in the community by secondary care staff, in addition to their usual care. The control group (n = 239) received usual care. Usual care included drug treatment, needs assessment and referral to appropriate services. Usual care at each site was recorded. MAIN OUTCOME MEASURES: The primary outcome was Dementia-Related Quality of Life score at 8 months post randomisation, with higher scores representing higher quality of life. Secondary outcomes included resource use, psychological well-being, self-management, instrumental activities of daily living and health-related quality of life. RANDOMISATION AND BLINDING: Participants were randomised in a 1 : 1 ratio. Staff conducting outcome assessments were blinded. DATA SOURCES: Outcome measures were administered in participants' homes at baseline and at 8 and 12 months post randomisation. Interviews were conducted with participants, participating carers and interventionalists. RESULTS: The mean Dementia-Related Quality of Life score at 8 months was 93.3 (standard deviation 13.0) in the intervention arm (n = 191) and 91.9 (standard deviation 14.6) in the control arm (n = 197), with a difference in means of 0.9 (95% confidence interval -1.2 to 3.0; p = 0.380) after adjustment for covariates. This effect size (0.9) was less than the 4 points defined as clinically meaningful. For other outcomes, a difference was found only for Diener's Flourishing Scale (adjusted mean difference 1.2, 95% confidence interval 0.1 to 2.3), in favour of the intervention (i.e. in a positive direction). The Journeying through Dementia intervention cost £608 more than usual care (95% confidence interval £105 to £1179) and had negligible difference in quality-adjusted life-years (-0.003, 95% confidence interval -0.044 to 0.038). Therefore, the Journeying through Dementia intervention had a mean incremental cost per quality-adjusted life-year of -£202,857 (95% confidence interval -£534,733 to £483,739); however, there is considerable uncertainty around this. Assessed fidelity was good. Interviewed participants described receiving some benefit and a minority benefited greatly. However, negative aspects were also raised by a minority. Seventeen per cent of participants in the intervention arm and 15% of participants in the control arm experienced at least one serious adverse event. None of the serious adverse events were classified as related to the intervention. LIMITATIONS: Study limitations include recruitment of an active population, delivery challenges and limitations of existing outcome measures. CONCLUSIONS: The Journeying through Dementia programme is not clinically effective, is unlikely to be cost-effective and cannot be recommended in its existing format. FUTURE WORK: Research should focus on the creation of new outcome measures to assess well-being in dementia and on using elements of the intervention, such as enabling enactment in the community. TRIAL REGISTRATION: This trial is registered as ISRCTN17993825. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 24. See the NIHR Journals Library website for further project information.

There are few services proven effective for people with mild dementia. We therefore explored the potential benefit of a programme called Journeying through Dementia. The content, devised in partnership with people living with dementia, aims to help affected individuals to live well and participate in life. The programme involves meeting in groups of about eight every week for 12 weeks. Each person also has four face-to-face meetings with a staff member. Carers are invited to 3 of the 12 group meetings to all individual meetings if the participant wanted this involvement. A total of 480 people with dementia and 350 carers from 13 locations in England took part. Just over half of the participants were randomly allocated to the new programme, whereas the others were not. This allowed us to compare the groups. We were interested in whether or not attending the Journeying through Dementia programme improved participants' quality of life. The results showed that it did not. We also measured participants' mood, self-management skills, positive attitudes and ability with daily living skills. Only one measure of positive psychology suggested even a small benefit. There was no difference between groups in the remaining measures. Although some individual participants described being more confident, enjoying social contact, trying new activities, feeling valued and having increased independence, overall, the programme is unlikely to be worth implementing. Certain aspects of the programme are worth implementing.

A multidomain decision support tool to prevent falls in older people: the FinCH cluster RCT.

BACKGROUND: Falls in care home residents are common, unpleasant, costly and difficult to prevent. OBJECTIVES: The objectives were to evaluate the clinical effectiveness and cost-effectiveness of the Guide to Action for falls prevention in Care Homes (GtACH) programme. DESIGN: A multicentre, cluster, parallel, 1 : 1 randomised controlled trial with embedded process evaluation and economic evaluation. Care homes were randomised on a 1 : 1 basis to the GtACH programme or usual care using a secure web-based randomisation service. Research assistants, participating residents and staff informants were blind to allocation at recruitment; research assistants were blind to allocation at follow-up. NHS Digital data were extracted blindly. SETTING: Older people's care homes from 10 UK sites. PARTICIPANTS: Older care home residents. INTERVENTION: The GtACH programme, which includes care home staff training, systematic use of a multidomain decision support tool and implementation of falls prevention actions, compared to usual falls prevention care. OUTCOMES: The primary trial outcome was the rate of falls per participating resident occurring during the 90-day period between 91 and 180 days post randomisation. The primary outcome for the cost-effectiveness analysis was the cost per fall averted, and the primary outcome for the cost-utility analysis was the incremental cost per quality adjusted life-year. Secondary outcomes included the rate of falls over days 0-90 and 181-360 post randomisation, activity levels, dependency and fractures. The number of falls per resident was compared between arms using a negative binomial regression model (generalised estimating equation). RESULTS: A total of 84 care homes were randomised: 39 to the GtACH arm and 45 to the control arm. A total of 1657 residents consented and provided baseline measures (mean age 85 years, 32% men). GtACH programme training was delivered to 1051 staff (71% of eligible staff) over 146 group sessions. Primary outcome data were available for 630 GtACH participants and 712 control participants. The primary outcome result showed an unadjusted incidence rate ratio of 0.57 (95% CI 0.45 to 0.71; p < 0.01) in favour of the GtACH programme. Falls rates were lower in the GtACH arm in the period 0-90 days. There were no other differences between arms in the secondary outcomes. Care home staff valued the training, systematic strategies and specialist peer support, but the incorporation of the GtACH programme documentation into routine care home practice was limited. No adverse events were recorded. The incremental cost was £20,889.42 per Dementia Specific Quality of Life-based quality-adjusted life-year and £4543.69 per quality-adjusted life-year based on the EuroQol-5 dimensions, five-level version. The mean number of falls was 1.889 (standard deviation 3.662) in the GtACH arm and 2.747 (standard deviation 7.414) in the control arm. Therefore, 0.858 falls were averted. The base-case incremental cost per fall averted was £190.62. CONCLUSION: The GtACH programme significantly reduced the falls rate in the study care homes without restricting residents' activity levels or increasing their dependency, and was cost-effective at current thresholds in the NHS. FUTURE WORK: Future work should include a broad implementation programme, focusing on scale and sustainability of the GtACH programme. LIMITATIONS: A key limitation was the fact that care home staff were not blinded, although risk was small because of the UK statutory requirement to record falls in care homes. TRIAL REGISTRATION: This trial is registered as ISRCTN34353836. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 9. See the NIHR Journals Library website for further project information.

Falls in care home residents are common, unpleasant, costly and hard to prevent. We tested whether or not the Guide to Action for falls prevention in Care Homes (GtACH) programme was effective in preventing falls. In this programme, care home staff were systematically trained and supported in the assessment of residents' risk of falling and the generation of a falls reduction care plan. We undertook a randomised controlled trial comparing the GtACH programme with usual care, which does not involve this systematic attention to falls prevention. We also undertook a process evaluation, observing organisational and care processes, and an economic study to evaluate value for money. A total of 39 care homes were randomly allocated to the GtACH programme and 45 care homes were randomly allocated to usual care, involving a total of 1657 residents. The main comparison between the two arms was the rate of falls during months 4­6 after randomisation, when we expected any effect to be at its peak. We also assessed the falls rates before and 6 months after this period. We measured activity and dependency levels, as it was important to be sure that any reduction in the rate of falls was not achieved through restrictive care practices. We saw a 43% reduction in the falls rates of the GtACH programme participants during months 4­6, without observing any reduction in residents' activity or dependency. Care home staff and relatives were positive about the GtACH programme. The GtACH programme was good value for money, as it was likely to be cost-effective. The effect of the programme waned over months 6­12, which may be because some staff did not embed the GtACH programme in their usual practice routines, and awareness levels may have dropped.

Psychological and Social Factors Associated with Coexisting Frailty and Cognitive Impairment: A Systematic Review.

Those living with coexistent frailty and cognitive impairment are at risk of poorer health outcomes. Research often focuses on identifying biological factors. This review sought to identify the association psychological and social factors have with coexisting physical and cognitive decline. Six databases were systematically searched in July 2020. Studies included individuals aged 60 years or older identified as being both frail and cognitively impaired. A narrative synthesis examined patterns within the data. Nine studies were included, most employed a cross-sectional design. Depression was investigated by all nine studies, those with coexistent frailty and cognitive impairment had higher levels of depressive symptoms than peers. Findings were mixed on social factors, although broadly indicate lower education, living alone and lower material wealth were more frequent in those living with coexistent decline. Further research is needed to explore potentially modifiable psychological and social factors which could lead to the development of supportive interventions.

Multifactorial falls prevention programme compared with usual care in UK care homes for older people: multicentre cluster randomised controlled trial with economic evaluation.

OBJECTIVES: To determine the clinical and cost effectiveness of a multifactorial fall prevention programme compared with usual care in long term care homes. DESIGN: Multicentre, parallel, cluster randomised controlled trial. SETTING: Long term care homes in the UK, registered to care for older people or those with dementia. PARTICIPANTS: 1657 consenting residents and 84 care homes. 39 were randomised to the intervention group and 45 were randomised to usual care. INTERVENTIONS: Guide to Action for Care Homes (GtACH): a multifactorial fall prevention programme or usual care. MAIN OUTCOME MEASURES: Primary outcome measure was fall rate at 91-180 days after randomisation. The economic evaluation measured health related quality of life using quality adjusted life years (QALYs) derived from the five domain five level version of the EuroQoL index (EQ-5D-5L) or proxy version (EQ-5D-5L-P) and the Dementia Quality of Life utility measure (DEMQOL-U), which were self-completed by competent residents and by a care home staff member proxy (DEMQOL-P-U) for all residents (in case the ability to complete changed during the study) until 12 months after randomisation. Secondary outcome measures were falls at 1-90, 181-270, and 271-360 days after randomisation, Barthel index score, and the Physical Activity Measure-Residential Care Homes (PAM-RC) score at 91, 180, 270, and 360 days after randomisation. RESULTS: Mean age of residents was 85 years. 32% were men. GtACH training was delivered to 1051/1480 staff (71%). Primary outcome data were available for 630 participants in the GtACH group and 712 in the usual care group. The unadjusted incidence rate ratio for falls between 91 and 180 days was 0.57 (95% confidence interval 0.45 to 0.71, P<0.001) in favour of the GtACH programme (GtACH: six falls/1000 residents v usual care: 10 falls/1000). Barthel activities of daily living indices and PAM-RC scores were similar between groups at all time points. The incremental cost was £108 (95% confidence interval -£271.06 to 487.58), incremental QALYs gained for EQ-5D-5L-P was 0.024 (95% confidence interval 0.004 to 0.044) and for DEMQOL-P-U was 0.005 (-0.019 to 0.03). The incremental costs per EQ-5D-5L-P and DEMQOL-P-U based QALY were £4544 and £20 889, respectively. CONCLUSIONS: The GtACH programme was associated with a reduction in fall rate and cost effectiveness, without a decrease in activity or increase in dependency. TRIAL REGISTRATION: ISRCTN34353836.

The implementation of Journeying through Dementia: Strategies to run a successful pragmatic multicenter trial of a complex intervention.

OBJECTIVE: A key challenge in delivering pragmatic trials of complex interventions is effective implementation within the study period and beyond. We describe a trial of an intervention to improve quality of life in mild dementia (Journeying through Dementia), describe some of the challenges raised in terms of implementation, and illustrate the methods used to ensure effective implementation. METHOD: The intervention was delivered by staff within local services and supervised by more experienced clinicians within those services in order to test the intervention in real-world settings and establish the potential for future embedding into practice. Researchers delivered training sessions for all facilitators and supervisors, met at regular intervals with intervention supervisors, and provided feedback on summaries of intervention sessions created by facilitators. We conducted a thematic analysis of the content of meetings and written correspondence between the researchers and intervention supervisors regarding implementation issues. RESULTS: Key themes relating to difficulties with implementation were: staff absences and staff leaving posts; participant lack of engagement with intervention; difficulties with delivery of supervision; difficult group dynamics; lack of time to deliver the intervention; and lack of adherence to the intervention and its ethos. CONCLUSION: We provide guidance for researchers involved in the trialing of other complex interventions in how these challenges might be overcome. These include: recruiting additional staff to deliver the intervention; having clear protocols in place for managing staff absences; using supervision to problem solve participant attendance at intervention sessions and difficult group dynamics; monitoring staff engagement in supervision and addressing problems with engagement with staff and managers when this occurs; giving staff ring-fenced time to deliver the intervention and engage in supervision; and regular monitoring and feedback in relation to the content of the intervention to ensure that it is consistent with ethos and content of the intervention manual.

Estimating the minimum important difference in the DEMQOL instrument in people with dementia.

PURPOSE: The Dementia-Related Quality of Life (DEMQOL) measure and the DEMQOL-Utility Score (DEMQOL-U) are validated tools for measuring quality of life (QOL) in people with dementia. What score changes translate to a clinically significant impact on patients' lives was unknown. This study establishes the minimal important differences (MID) for these two instruments. METHODS: Anchor-based and distribution-based methods were used to estimate the MID scores from patients enrolled in a randomised controlled trial. For the anchor-based method, the global QOL (Q29) item from the DEMQOL was chosen as the anchor for DEMQOL and both Q29 and EQ-5D for DEMQOL-U. A one category difference in Q29, and a 0.07 point difference in EQ-5D score, were used to classify improvement and deterioration, and the MID scores were calculated for each category. These results were compared with scores obtained by the distribution-based methods. RESULTS: A total of 490 people with dementia had baseline DEMQOL data, of these 386 had 8-month data, and 344 had 12-month DEMQOL data. The absolute change in DEMQOL for a combined 1-point increase or decrease in the Q29 anchor was 5.2 at 8 months and 6.0 at 12 months. For the DEMQOL-U, the average absolute change at 8 and 12 months was 0.032 and 0.046 for the Q29 anchor and 0.020 and 0.024 for EQ-5D anchor. CONCLUSION: We present MID scores for the DEMQOL and DEMQOL-U instruments obtained from a large cohort of patients with dementia. An anchored-based estimate of the MID for the DEMQOL is around 5 to 6 points; and 0.02 to 0.05 points for the DEMQOL-U. The results of this study can guide clinicians and researchers in the interpretation of these instruments comparisons between groups or within groups of people with dementia. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: ISRCTN17993825 on 11th October 2016.

What influences uptake of psychosocial interventions by people living with early dementia? A qualitative study.

BACKGROUND: Health policy promotes post-diagnostic support for people affected by dementia. Evidence suggests psychosocial interventions can effectively support people living with dementia after diagnosis. Yet, what influences uptake of psychosocial interventions by people with early dementia is poorly understood. This research aimed to identify influences on uptake of psychosocial interventions by people with early dementia. METHODS: Sixteen face-to-face semi-structured interviews with people with early dementia, either alone or with a family member(s), were completed. Twelve staff participated in semi-structured interviews or a focus group. Thematic analysis and triangulation enabled identification of overall themes across different participant groups and interview types. MAIN FINDINGS: Four overarching themes influencing uptake were identified: (1) adjusting to a diagnosis, (2) appeal of activities and perception of benefit, (3) service and societal context, and (4) relationships and communication. Individual responses to diagnosis, experiences of dementia and dementia services influenced uptake. Group interventions were discussed the most by all participants. Group interventions offering social contact, peer support, information, enjoyable activities and mental stimulation were valued. However, group interventions specifically aimed at people with dementia did not appeal to all. Ability to travel and convenience of locations were important. Continuing with community activities not focused on dementia was valued. Stigma around dementia appeared to discourage uptake. Emotional and practical support from family was key to facilitating uptake as were the relationships between people with dementia and staff. CONCLUSION: A complex interplay of individual, service and societal influences affect uptake of psychosocial interventions by people with early dementia. How interventions and which services can enable people with early dementia remain engaged in their everyday lives needs consideration. Further research examining uptake of specific interventions commonly offered to people living with early dementia is needed. Involving people with early dementia in designing interventions aiming to support them is paramount.

Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial.

BACKGROUND: Understanding intervention delivery as intended, particularly in complex interventions, should be underpinned by good quality fidelity assessment. We present the findings from a fidelity assessment embedded as part of a trial of a complex community-based psychosocial intervention, Journeying through Dementia (JtD). The intervention was designed to equip individuals with the knowledge and skills to successfully self-manage, maintain independence, and live well with dementia and involves both group and individual sessions. The methodological challenges of developing a conceptual framework for fidelity assessment and creating and applying purposely designed measures derived from this framework are discussed to inform future studies. METHODS: A conceptual fidelity framework was created out of core components of the intervention (including the intervention manual and training for delivery), associated trial protocols and pre-defined fidelity standards and criteria against which intervention delivery and receipt could be measured. Fidelity data collection tools were designed and piloted for reliability and usability. Data collection in four selected sites (fidelity sites) was via non-participatory observations of the group aspect of the intervention, attendance registers and interventionist (facilitator and supervisor) self-report. RESULTS: Interventionists from all four fidelity sites attended intervention training. The majority of group participants at the four sites (71%) received the therapeutic dose of 10 out of 16 sessions. Weekly group meeting attendance (including at 'out of venue' sessions) was excellent at 80%. Additionally, all but one individual session was attended by the participants who completed the intervention. It proved feasible to create tools derived from the fidelity framework to assess in-venue group aspects of this complex intervention. Results of fidelity assessment of the observed groups were good with substantial inter-rater reliability between researchers KAPPA 0.68 95% CI (0.58-0.78). Self-report by interventionists concurred with researcher assessments. CONCLUSIONS: There was good fidelity to training and delivery of the group aspect of the intervention at four sites. However, the methodological challenges of assessing all aspects of this complex intervention could not be overcome due to practicalities, assessment methods and ethical considerations. Questions remain regarding how we can assess fidelity in community-based complex interventions without impacting upon intervention or trial delivery. TRIAL REGISTRATION: ISRCTN17993825 .

Journeying through Dementia Randomised Controlled Trial of a Psychosocial Intervention for People Living with Early Dementia: Embedded Qualitative Study with Participants, Carers and Interventionists.

OBJECTIVE: To identify the barriers and facilitators to the implementation of a complex psychosocial intervention though a study exploring the experiences of participants, carers and interventionists during a trial. METHODS: Individual semi-structured interviews were conducted with participants, their carers, and interventionists from a sample of recruiting sites that took part in the Journeying through Dementia randomized controlled trial (RCT). Interview data were transcribed and analysed using framework analysis. Co-researcher data analysis workshops were also conducted to explore researcher interpretations of the data through the lens of those with lived experience of dementia. Triangulation enabled comparison of findings from the interviews with findings from the co-researcher workshops. RESULTS: Three main themes emerged from the interview data: being prepared; intervention engagement; and participation and outcomes from engagement. From these themes, a number of factors that can moderate delivery and receipt of the intervention as intended were identified. These were context and environment; readiness, training, skills and competencies of the workforce; identifying meaningful participation and relationships. CONCLUSION: This study highlighted that the observed benefit of the intervention was nuanced for each individual. Mechanisms of change were influenced by a range of individual, social and contextual factors. Future research should therefore consider how best to identify and measure the multifaceted interplay of mechanisms of change in complex interventions. TRIAL REGISTRATION: ISRCTN17993825.

Hearing and vision care provided to older people residing in care homes: a cross-sectional survey of care home staff.

BACKGROUND: Hearing and vision loss in older people has been proven to affect physical and mental health and increase the speed of cognitive decline. Studies have demonstrated that certain practices and improved staff knowledge increase the effective care of residents' ears and eyes, yet it is not known which practices are being implemented in care homes. This study aimed to identify the gaps in staff knowledge regarding hearing and vision difficulties in older residents, and which practices known to improve ear and eye care in older care home residents are not commonly implemented in care homes in England. METHODS: This study used a cross-sectional survey design. Survey questions were informed by the existing literature and were focused on practices, staff knowledge, and other aspects that have shown to affect residents' hearing and vision care. A convenience sample of care home staff were recruited from care homes across England between November 2018 and February 2019 via email and in paper format. Descriptive statistics and Chi-Square analysis were applied to identify the factors influencing the care being provided to care home residents. RESULTS: A total of 400 care home staff responded from 74 care homes. The results revealed that less than half of staff respondents reported to use screening tools to identify hearing (46%) and vision impairments (43.8%); that care homes rarely have access to other assistive devices for hearing (16%) and vision loss (23.8%), and that audiology services do not regularly assess care home residents (46.8%). A majority of staff who responded were not confident in ear and eye care. Responses were found to be influenced by the respondents' job role, length of time working in care homes and also the care home type. Findings confirmed a lack of standardised practice and the importance of shared communication for promulgation of best practice. CONCLUSION: This study has identified that some practices known to facilitate ear and eye care are not commonly applied in a sample of English care homes. It has also shown that care home staff knowledge of ear and eye care is inconsistent. The information derived from this survey can be used to inform guidelines for best practice and inform needs for future research.

Community Occupational Therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID]) study: A single-blind, randomised controlled trial.

BACKGROUND: We aimed to estimate the clinical effectiveness of Community Occupational Therapy for people with dementia and family carers-UK version (Community Occupational Therapy in Dementia-UK version [COTiD-UK]) relative to treatment as usual (TAU). We hypothesised that COTiD-UK would improve the ability of people with dementia to perform activities of daily living (ADL), and family carers' sense of competence, compared with TAU. METHODS AND FINDINGS: The study design was a multicentre, 2-arm, parallel-group, assessor-masked, individually randomised controlled trial (RCT) with internal pilot. It was conducted in 15 sites across England from September 2014 to January 2018. People with a diagnosis of mild to moderate dementia living in their own home were recruited in pairs with a family carer who provided domestic or personal support for at least 4 hours per week. Pairs were randomised to either receive COTiD-UK, which comprised 10 hours of occupational therapy delivered over 10 weeks in the person with dementia's home or TAU, which comprised the usual local service provision that may or may not include standard occupational therapy. The primary outcome was the Bristol Activities of Daily Living Scale (BADLS) score at 26 weeks. Secondary outcomes for the person with dementia included the following: the BADLS scores at 52 and 78 weeks, cognition, quality of life, and mood; and for the family carer: sense of competence and mood; plus the number of social contacts and leisure activities for both partners. Participants were analysed by treatment allocated. A total of 468 pairs were recruited: people with dementia ranged from 55 to 97 years with a mean age of 78.6 and family carers ranged from 29 to 94 with a mean of 69.1 years. Of the people with dementia, 74.8% were married and 19.2% lived alone. Of the family carers, 72.6% were spouses, and 22.2% were adult children. On randomisation, 249 pairs were assigned to COTiD-UK (62% people with dementia and 23% carers were male) and 219 to TAU (52% people with dementia and 32% carers were male). At the 26 weeks follow-up, data were available for 364 pairs (77.8%). The BADLS score at 26 weeks did not differ significantly between groups (adjusted mean difference estimate 0.35, 95% CI -0.81 to 1.51; p = 0.55). Secondary outcomes did not differ between the groups. In total, 91% of the activity-based goals set by the pairs taking part in the COTiD-UK intervention were fully or partially achieved by the final COTiD-UK session. Study limitations include the following: Intervention fidelity was moderate but varied across and within sites, and the reliance on primarily proxy data focused on measuring the level of functional or cognitive impairment which may not truly reflect the actual performance and views of the person living with dementia. CONCLUSIONS: Providing community occupational therapy as delivered in this study did not improve ADL performance, cognition, quality of life, or mood in people with dementia nor sense of competence or mood in family carers. Future research should consider measuring person-centred outcomes that are more meaningful and closely aligned to participants' priorities, such as goal achievement or the quantity and quality of activity engagement and participation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10748953.

Exploring factors that affect the uptake and sustainability of videoconferencing for healthcare provision for older adults in care homes: a realist evaluation.

BACKGROUND: Videoconferencing has been proposed as a way of improving access to healthcare for older adults in care homes. Despite this, effective uptake of videoconferencing remains varied. This study evaluates a videoconferencing service for care home staff seeking support from healthcare professionals for the care of residents. The aim was to explore factors affecting the uptake and sustainability of videoconferencing in care homes, to establish what works for whom, in which circumstances and respects. The findings informed recommendations for commissioners and strategic managers on how best to implement videoconferencing for remote healthcare provision in care homes for older adults. METHODS: Realist evaluation was used to develop, refine and test theories around the uptake and maintenance of videoconferencing in three care homes across Yorkshire and the Humber, England. The care homes were selected using maximum variation sampling regarding the extent to which they used videoconferencing. A developmental inquiry framework and realist interviews were used to identify Context, Mechanism and Outcome Configurations (CMOCs) regarding uptake and sustainability of the service. Participants included care home residents (aged > 65) and staff, relatives and strategic managers of care home chains. The interviews were an iterative process conducted alongside data analysis. Transcripts of audio recordings were entered into NVIVO 12, initially coded into themes, then hypotheses developed, refined and tested. RESULTS: Outcomes were generated in relation to two main contextual factors, these were: (1) communication culture in the home and (2) the prior knowledge and experience that staff have of videoconferencing. The key facilitators identified were aspects of leadership, social links within the home and psychological safety which promoted shared learning and confidence in using the technology. CONCLUSIONS: Videoconferencing is a valuable tool, but successful implementation and sustainability are dependent on care home culture and staff training to promote confidence through positive and supported experiences.

Feasibility and acceptability evaluation of the Promoting Independence in Dementia (PRIDE) intervention for living well with dementia.

OBJECTIVES: Post-diagnostic psychosocial interventions could play an important role in supporting people with mild dementia remain independent. The Promoting Independence in Dementia (PRIDE) intervention was developed to address this. METHOD: The mixed methods non-randomized, pre-post feasibility study occurred across England. Facilitators were recruited from the voluntary sector and memory services. Participants and their supporters took part in the three-session intervention. Outcome measures were collected at baseline and follow-up. To evaluate acceptability, focus groups and interviews were conducted with a subsample of participants and facilitators. RESULTS: Contextual challenges to delivery including national research governance changes, affected recruitment of study sites. Thirty-four dyads consented, with 14 facilitators providing the intervention. Dyads took part in at least two sessions (79%), and 73% in all three. Outcome measures were completed by 79% without difficulty, with minimal missing data. No significant changes were found on pre and post assessments. Post hoc analysis found moderate effect size improvements for self-management (SMAS instrument) in people with dementia (d = 0.41) and quality of life (EQ5D measure) in carers (d = 0.40). Qualitative data indicated that dyads found PRIDE acceptable, as did intervention facilitators. CONCLUSIONS: The three-session intervention was well accepted by participant-dyads and intervention facilitators. A randomized controlled trial of PRIDE would need to carefully consider recruitment potential across geographically varied settings and site stratification according to knowledge of contextual factors, such as the diversity of post-diagnostic services across the country. Letting sites themselves be responsible for identifying suitable intervention facilitators was successful. The self-report measures showed potential to be included in the main trial.

Ensuring that COVID-19 research is inclusive: guidance from the NIHR INCLUDE project.

OBJECTIVE: To provide guidance to researchers, funders, regulators and study delivery teams to ensure that research on COVID-19 is inclusive, particularly of groups disproportionately affected by COVID-19 and who may have been historically under-served by research. SUMMARY OF KEY POINTS: Groups who are disproportionately affected by COVID-19 include (but are not limited to) older people, people with multiple long-term conditions, people with disabilities, people from Black, Asian and Ethnic minority groups, people living with obesity, people who are socioeconomically deprived and people living in care homes. All these groups are under-served by clinical research, and there is an urgent need to rectify this if COVID-19 research is to deliver relevant evidence for these groups who are most in need. We provide a framework and checklists for addressing key issues when designing and delivering inclusive COVID-19 research, based on the National Institute for Health Research INnovations in CLinical trial design and delivery for the UnDEr-served project roadmap. Strong community engagement, codevelopment and prioritisation of research questions and interventions are essential. Under-served groups should be represented on funding panels and ethics committees, who should insist on the removal of barriers to participation. Exclusion criteria should be kept to a minimum; intervention delivery and outcome measurement should be simple, flexible and tailored to the needs of different groups, and local advice on the best way to reach and engage with under-served communities should be taken by study delivery teams. Data on characteristics that allow identification of under-served groups must be collected, analyses should include these data to enable subgroup comparisons and results should be shared with under-served groups at an early stage. CONCLUSION: Inclusive COVID-19 research is a necessity, not a luxury, if research is to benefit all the communities it seeks to serve. It requires close engagement with under-served groups and attention to aspects of study topic, design, delivery, analysis and dissemination across the research life cycle.