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Background Remote home monitoring services were developed and implemented for patients with COVID-19 during the pandemic. Patients monitored blood oxygen saturation and other readings (e.g. temperature) at home and were escalated as necessary. Objective To evaluate effectiveness, costs, implementation, and staff and patient experiences (including disparities and mode) of COVID-19 remote home monitoring services in England during the COVID-19 pandemic (waves 1 and 2). Methods A rapid mixed-methods evaluation, conducted in two phases. Phase 1 (July–August 2020) comprised a rapid systematic review, implementation and economic analysis study (in eight sites). Phase 2 (January–June 2021) comprised a large-scale, multisite, mixed-methods study of effectiveness, costs, implementation and patient/staff experience, using national data sets, surveys (28 sites) and interviews (17 sites). Results Phase 1 Findings from the review and empirical study indicated that these services have been implemented worldwide and vary substantially. Empirical findings highlighted that communication, appropriate information and multiple modes of monitoring facilitated implementation; barriers included unclear referral processes, workforce availability and lack of administrative support. Phase 2 We received surveys from 292 staff (39% response rate) and 1069 patients/carers (18% response rate). We conducted interviews with 58 staff, 62 patients/carers and 5 national leads. Despite national roll-out, enrolment to services was lower than expected (average enrolment across 37 clinical commissioning groups judged to have completed data was 8.7%). There was large variability in implementation of services, influenced by patient (e.g. local population needs), workforce (e.g. workload), organisational (e.g. collaboration) and resource (e.g. software) factors. We found that for every 10% increase in enrolment to the programme, mortality was reduced by 2% (95% confidence interval: 4% reduction to 1% increase), admissions increased by 3% (−1% to 7%), in-hospital mortality fell by 3% (−8% to 3%) and lengths of stay increased by 1.8% (−1.2% to 4.9%). None of these results are statistically significant. We found slightly longer hospital lengths of stay associated with virtual ward services (adjusted incidence rate ratio 1.05, 95% confidence interval 1.01 to 1.09), and no statistically significant impact on subsequent COVID-19 readmissions (adjusted odds ratio 0.95, 95% confidence interval 0.89 to 1.02). Low patient enrolment rates and incomplete data may have affected chances of detecting possible impact. The mean running cost per patient varied for different types of service and mode; and was driven by the number and grade of staff. Staff, patients and carers generally reported positive experiences of services. Services were easy to deliver but staff needed additional training. Staff knowledge/confidence, NHS resources/workload, dynamics between multidisciplinary team members and patients’ engagement with the service (e.g. using the oximeter to record and submit readings) influenced delivery. Patients and carers felt services and human contact received reassured them and were easy to engage with. Engagement was conditional on patient, support, resource and service factors. Many sites designed services to suit the needs of their local population. Despite adaptations, disparities were reported across some patient groups. For example, older adults and patients from ethnic minorities reported more difficulties engaging with the service. Tech-enabled models helped to manage large patient groups but did not completely replace phone calls. Limitations Limitations included data completeness, inability to link data on service use to outcomes at a patient level, low survey response rates and under-representation of some patient groups. Future work Further research should consider the long-term impact and cost-effectiveness of these services and the appropriateness of different models for different groups of patients. Conclusions We were not able to find quantitative evidence that COVID-19 remote home monitoring services have been effective. However, low enrolment rates, incomplete data and varied implementation reduced our chances of detecting any impact that may have existed. While services were viewed positively by staff and patients, barriers to implementation, delivery and engagement should be considered. Study registration This study is registered with the ISRCTN (14962466). Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (RSET: 16/138/17; BRACE: 16/138/31) and NHSEI and will be published in full in Health and Social Care Delivery Research; Vol. 11, No. 13. See the NIHR Journals Library website for further project information. The views expressed in this publication are those of the authors and not necessarily those of the National Institute for Health and Care Research or the Department of Health and Social Care. Plain language summary The problem COVID-19 patients can experience very low oxygen levels, without feeling breathless. Patients may not realise there is a problem until they become extremely unwell, risking being admitted to hospital too late. To address this, COVID-19 remote home monitoring services were developed and later rolled out across England. Patients monitored oxygen levels at home using an ‘oximeter’ (a small device which clips on to your finger) and sent these readings to providers via phone or technology (e.g. an app). Patients could access further care if needed. We did not know whether these services worked, or what people felt about them. We looked at •How services were set up and used in England. •Whether services work (e.g. by reducing deaths and length of hospital stay). •How much they cost. •What patients, carers and staff think about these services (including differences between groups and telephone vs. technology). What we did We looked at available existing evidence and collected data from eight services operating in the first wave of the pandemic. During the second wave of the pandemic, we used data available at a national level and conducted surveys (28 sites) and interviews (17 sites) with staff, patients and individuals involved in developing/leading services nationally. What we found These services have been used worldwide, but they vary considerably. We found many things that help these services to be used (e.g. good communication) but also things that get in the way (e.g. unclear referrals). Our findings did not show that services reduce deaths or time in hospital. But these findings are limited by a lack of data. Staff and patients liked these services, but we found some barriers to delivering and using the service. Some groups found services harder to use (e.g. older patients, those with disabilities and ethnic minorities). Using technology helped with large patient groups, but it did not completely replace phone calls. Conclusion Better information is needed to know whether these services work. Staff and patients liked these services. However, improvements may make them easier to deliver and use (e.g. further staff training and giving additional support to patients who need it). Scientific summary Background and rationale Delays in the presentation of patients with COVID-19 has led to patients arriving at hospital with very low oxygen saturations often without breathlessness (‘silent hypoxia’). This has resulted in patients being admitted to hospital with advanced COVID-19, thus requiring invasive treatment, potential admission to intensive care and poorer outcomes. Remote home monitoring models that systematically record and communicate patients’ physiological parameters to clinicians are currently being used globally for a variety of conditions. These models offer a potential solution for reducing the delays in providing appropriate treatment for patients with COVID-19 by identifying at-risk patients earlier. As a result, services providing remote home monitoring using pulse oximetry for patients with COVID-19 were developed ad hoc in some areas in England during the first wave of the pandemic (March to July 2020). Learning from these earlier services, NHS England and NHS Improvement (in November 2020) launched a national roll-out of a model of care called ‘COVID Oximetry @home (CO@h)’, followed by early discharge models, referred to as ‘virtual wards’ (in January 2021). We refer to these services as COVID-19 remote home monitoring services. All of these services provide patients with an oximeter and ask them to regularly record and relay their oxygen levels (alongside other generic COVID-19 symptoms) to a supporting team of administrators and clinicians via a smartphone application (app), e-mail or online portal, or over the telephone. Patients being monitored are escalated to receive additional care if necessary. Previous research has explored remote home monitoring for other conditions, but there is a lack of research on the effectiveness, cost, implementation and staff/patient experiences of remote home monitoring models for COVID-19. This study explored the impact and implications of these COVID-19 remote home monitoring services during the first and second waves of the pandemic. Phase 1 Phase 1 of this evaluation (during the first wave of the pandemic) aimed to answer the following research questions: 1.How have remote home monitoring services been implemented for COVID-19 and what are their main components, processes of implementation, target patient populations, impact on outcomes, costs and lessons learned? 2.What were the characteristics of remote home monitoring models for COVID-19, experiences of staff implementing these models, data processes and lessons learned during wave 1 of the pandemic? Phase 2 Phase 2 of this evaluation (during wave 2 of the pandemic) aimed to answer the following research questions: 1.Are COVID-19 remote home monitoring services associated with changes in mortality and use of hospital services? Does the use of tech-enabled oximetry have a measurable effect on mortality and hospitalisations? 2.What were the costs of setting up and running COVID-19 remote home monitoring services and how do these costs vary between tech-enabled and analogue, and analogue-only data submission modes? 3.What are the factors influencing delivery and implementation of COVID-19 remote home monitoring services? Do these vary by type of model, geography, mode of remote monitoring approach (tech-enabled vs. analogue)? 4.What are the experiences and behaviours (i.e. engagement with services, use of other services) of patients receiving COVID-19 remote home monitoring services? Do these vary by type of model, patient characteristics, mode of remote monitoring (tech-enabled vs. analogue)? 5.Are there potential impacts on inequalities? 6.What are the experiences of staff delivering COVID-19 remote home monitoring services? Do these vary by mode of remote monitoring (tech-enabled vs. analogue)? Methods This study used mixed methods consisting of two phases. Phase 1 Phase 1 (data collected between July and August 2020) comprised a rapid systematic review (n = 27 articles) and an empirical mixed-methods implementation study of staff experiences, the use of data for monitoring progress against outcomes, variability in staffing and resource allocation, patient numbers and impact and lessons learnt (in eight sites). Phase 2 Phase 2 (data collected between January and June 2021) was a large-scale, multisite, mixed-methods study, including: effectiveness, cost analysis, implementation and patient/staff experience (in 28 sites). To explore impact and effectiveness of remote home monitoring services relating to hospitalisations and mortality, we used routinely available data, hospital administrative data and aggregated and other information produced by the programme. To explore costs of setting up and running COVID-19 remote home monitoring services, we collected aggregated data on patient numbers, staffing models, and allocation of resources from 26/28 sites. To explore implementation, staff experiences of delivering these services, patient experiences of receiving and engaging with these services (including a focus on inequalities and technology-enabled and analogue vs. analogue-only models), we conducted surveys and interviews with staff, patients and carers, and interviewed national leads. We involved patients, carers and the public throughout the project. Members of the study team met with members of the Birmingham, RAND and Cambridge Evaluation Centre and Rapid Service Evaluation Team patient and public involvement groups throughout the project (four meetings), to discuss various aspects of the project, including but not limited to the research questions, data collection tools and findings. Results A summary of findings is provided in Figure A. FIGURE ASummary of key findings. Phase 1 Findings from the systematic review indicated that remote home monitoring services have been implemented internationally for COVID-19. Findings from the review and empirical study highlighted that models of remote home monitoring for COVID-19 varied internationally and within England. Many factors facilitated implementation, including good communication within clinical teams, culturally appropriate information for patients and carers, and the combination of multiple approaches for patient monitoring (app and paper based). Findings from phase 1 were disseminated widely and used to inform decisions in relation to the future roll-out of services and the design of phase 2. Phase 2 We received surveys from 292 staff (39% response rate) and 1069 patients/carers (18% response rate), and conducted interviews with 58 staff, 62 patients/carers and 5 national leads. The rapid development of national remote home monitoring services took place in three phases: local development (during wave 1 of the pandemic), national development and roll-out (between waves 1 and 2 of the pandemic) and local implementation (during wave 2 of the pandemic). Despite national roll-out, enrolment of people to COVID-19 remote home monitoring services was lower than expected and there was large variability in the models of remote home monitoring services that were implemented. This variation was influenced by patient, workforce, organisational and resource factors. The overall enrolment rate to the service across 37 clinical commissioning groups judged to have complete data was 8.7%. We found that for every 10% increase in enrolment to the programme, mortality was reduced by 2% (95% confidence interval [CI] 4% reduction to 1% increase), admissions increased by 3% (95% CI −1% to 7%), in-hospital mortality fell by 3% (95% CI −8% to 3%) and lengths of stay increased by 1.8% (95% CI −1.2% to 4.9%). None of these results are statistically significant. For COVID virtual wards (CVW), we found that the roll-out of virtual ward services for COVID-19 did not reduce rates of readmission (adjusted odds ratio 0.95, 95% CI 0.89 to 1.02) or lengths of stay in hospital. In fact, our analysis indicated longer lengths of stay (adjusted incidence rate ratio 1.05, 95% CI 1.01 to 1.09). The mean running cost per patient monitored under the CO@h services was slightly lower compared with CVW services (£527.5 vs. £599.1). For CO@h and CVW services the mean cost per patient monitored at home was lower in sites using both tech-enabled and analogue modes of data submission compared with the sites using analogue-only modes. The majority of staff involved in running COVID-19 remote home monitoring services were clinical staff. Over 50% of staff (clinical and non-clinical staff combined) were employed at band 5 or below in the CO@h service, whereas in CVW services there were slightly more staff on band 6 or above. Staff generally reported positive experiences of delivery (75% of staff reported a positive impact of their role on job satisfaction); they felt that services were easy to deliver and they valued the support provided. However, findings indicated that staff would have benefited from further training; 41% of service leads and 12% of delivery staff identified further training or support needs. Factors influencing delivery of remote home monitoring services for COVID-19 included: staff knowledge and confidence, NHS resources and capacity on staff workload, multidisciplinary team dynamics, and patient (dis)engagement. Patients and carers reported positive experiences (93% rated the service as good or excellent) and felt that services and human contact received as part of these services reassured them and were easy to engage with. Findings indicated that patients with COVID-19 can engage with remote monitoring services but may require support from staff and family/friends to do so. Engagement was conditional on a range of factors including patient factors, support and resources, and service characteristics. Findings indicate that burden of treatment may be experienced by patients and families with acute conditions. Many sites designed their service to be inclusive of the needs of local populations to ensure broad reach, and many sites adapted their service locally to suit specific patient needs to encourage engagement. Despite these local adaptations to services, disparities were reported across patient groups. Age (p

Background People with dementia find it increasingly difficult to carry out daily activities (activities of daily living), and may require increasing support from family carers. Researchers in the Netherlands developed the Community Occupational Therapy in Dementia intervention, which was delivered in 10 1-hour sessions over 5 weeks to people with dementia and their family carers at home. Community Occupational Therapy in Dementia was found to be clinically effective and cost-effective. Objectives Translate and adapt Community Occupational Therapy in Dementia to develop the Community Occupational Therapy in Dementia - the UK version intervention and training programme and to optimise its suitability for use within the UK. To estimate the clinical effectiveness and cost-effectiveness of Community Occupational Therapy in Dementia - the UK version for people with mild to moderate dementia and their family carers compared with treatment as usual. Design The development phase used mixed methods to develop Community Occupational Therapy in Dementia - the UK version: translation, expert review, and adaptation of the manual and training materials; training occupational therapists; focus groups and interviews, including occupational therapists, managers, people with dementia and family carers; consensus conference; and an online survey of occupational therapists to scope UK practice. A multicentre, two-arm, parallel-group, single-blind individually randomised pragmatic trial was preceded by an internal pilot. Pairs were randomly allocated between Community Occupational Therapy in Dementia - the UK version and treatment as usual. A cost–utility analysis, fidelity study and qualitative study were also completed. Setting Community services for people with dementia across England. Participants People with mild to moderate dementia recruited in pairs with a family carer/supporter. Interventions Community Occupational Therapy in Dementia - the UK version is an activity-based, goal-setting approach for people with dementia and family carers, and is delivered at home by an occupational therapist for 10 hours over 10 weeks. Treatment as usual comprised the usual local service provision, which may or may not include standard occupational therapy. Main outcome measures Data were collected through interviews conducted in person with dyads at baseline and at 12 and 26 weeks post randomisation, and then over the telephone with a reduced sample of just carers at 52 and 78 weeks post randomisation. The primary outcome was the Bristol Activities of Daily Living Scale at 26 weeks. The secondary outcomes were as follows: person with dementia – cognition, activities of daily living, quality of life and mood; carer – sense of competence, quality of life and mood; all participants – social contacts, leisure activities and serious adverse events. Results The Community Occupational Therapy in Dementia manual and training materials were translated and reviewed. In total, 44 occupational therapists were trained and delivered Community Occupational Therapy in Dementia to 130 pairs. A total of 197 occupational therapists completed the survey, of whom 138 also provided qualitative data. In total, 31 people attended the consensus conference. Community Occupational Therapy in Dementia - the UK version has more flexibility than Community Occupational Therapy in Dementia in terms of content and delivery; for example, occupational therapists can use the wider range of assessment tools that are already in regular use within UK practice and the time span for delivery is 10 weeks to better meet the needs of pairs and be more feasible for services to deliver. In total, 31 occupational therapists provided Community Occupational Therapy in Dementia - the UK version within the randomised controlled trial. A total of 468 pairs were randomised (249 pairs to Community Occupational Therapy in Dementia - the UK version, 219 pairs to treatment as usual). People with dementia ranged in age from 55 to 97 years (mean 78.6 years), and family carers ranged in age from 29 to 94 years (mean 69.1 years). The majority of those with dementia (74.8%) were married; 19.2% lived alone. Most family carers (72.6%) were spouses but 22.2% were adult children. At 26 weeks, 406 (87%) pairs remained in the trial, and the Bristol Activities of Daily Living Scale total score did not differ at the 5% level when comparing groups (adjusted mean difference estimate 0.35, 95% confidence interval –0.81 to 1.51; p = 0.55). The adjusted (for baseline Bristol Activities of Daily Living Scale total score and randomised group) intracluster correlation coefficient estimate at week 26 was 0.043. There were no significant differences in secondary outcomes. At 52 and 78 weeks, there were no differences between the two groups in Bristol Activities of Daily Living Scale total score and secondary outcomes. The probability that Community Occupational Therapy in Dementia - the UK version is cost-effective at a threshold of willingness to pay per quality-adjusted life-year of £20,000 is 0.02%. In the qualitative interviews, participants reported positive benefits and outcomes. Of the 249 pairs allocated to Community Occupational Therapy in Dementia - the UK version, 227 reached the goal-setting phase, and 838 of the 920 goals set (90.8%) were fully or partially achieved. Limitations The development phase took longer than estimated because of translation time and organisational delays in delivering the intervention. Recruitment to the randomised controlled trial took longer than expected. Fidelity overall was moderate, with variation across sites and therapists. It is possible that Community Occupational Therapy in Dementia - the UK version did not work well in the UK service model in which usual care differs from that in the Netherlands. Conclusions This programme used a rigorous process to develop Community Occupational Therapy in Dementia - the UK version but found no statistical evidence of clinical effectiveness or cost-effectiveness compared with usual care. Qualitative findings provided positive examples of how Community Occupational Therapy in Dementia - the UK version had enabled people to live well with dementia. Future work Developing tools to measure more meaningful outcomes, such as goals achieved or the quantity and quality of activity participation, with less reliance on proxy data, to collect the views and experiences of people with dementia themselves. Trial registration This trial was registered as ISRCTN10748953 (WP3 and WP4). Funding This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 11, No. 5. See the NIHR Journals Library website for further project information. Plain language summary Maintaining everyday and meaningful activities can be difficult for a person with dementia. Their family carer/supporter can feel stressed from needing to give increasing support. Occupational therapists assist people to improve their health and well-being by helping them to do the activities that are important to them. Dutch researchers developed an occupational therapy programme for people with mild to moderate dementia and their supporters. Delivered at home, it improved the person’s ability to carry out daily activities, plus their mood and quality of life. Supporters’ sense of competence, mood and quality of life also improved, and it was also value for money. We built on this by translating and adapting the Dutch materials to develop a version better suited to the UK health and social care services context: Community Occupational Therapy in Dementia – UK version. The Community Occupational Therapy in Dementia – UK version comprises 10 hours of occupational therapy provided at home over 10 weeks. We tested whether or not it was more beneficial in terms of helping people with dementia to continue with activities and improving mood and quality of life than the usual service provided (treatment as usual), which may or may not include occupational therapy. In total, 468 pairs comprising a person with dementia and their supporter agreed to take part. Pairs were allocated at random to receive either The Community Occupational Therapy in Dementia – UK version or treatment as usual. We asked questions about daily activities performance, quality of life, mood, and the health and social care services used. We did this at the beginning of the programme and again at 12, 26, 52 and 78 weeks. The statistical analysis showed no evidence that Community Occupational Therapy in Dementia – UK version benefited the pairs on the outcomes selected or was value for money compared with the usual care already provided. We spoke in depth to some of the pairs and occupational therapists who participated in Community Occupational Therapy in Dementia – UK version, and they provided positive examples of meaningful activities that they had resumed or established as a result of the programme. Future research should develop ways of measuring the outcomes that really matter to people with dementia and their supporters, and to collect the views of people with dementia themselves. Scientific summary Background People with dementia find it increasingly difficult to carry out activities, and require increasing support from their family carers, who often experience stress. Occupational therapists support people to improve their health and well-being by enabling them to participate in activities that are meaningful to them. Researchers in the Netherlands developed the Community Occupational Therapy in Dementia (COTiD) intervention, in which occupational therapists delivered in 10 1-hour sessions over 5 weeks to people with mild to moderate dementia and their family carers at home. The Dutch researchers found that COTiD improved the person with dementia’s ability to perform daily living activities [activities of daily living (ADL)], quality of life and mood; improved their family carer’s sense of competence, quality of life and mood; and was cost-effective. Aims and objectives The aim of this applied research programme funded by the National Institute for Health and Care Research (NIHR) was to translate, adapt, evaluate and implement this community occupational therapy intervention designed to promote independence, meaningful activity and quality of life for people with mild to moderate dementia, and thus to benefit their family carers. Objectives •To translate and adapt COTiD into the Community Occupational Therapy in Dementia – UK version (COTiD-UK) intervention and training programme and optimise it for UK use. •To test the feasibility of implementing COTiD within UK health and social care services. •To field test the proposed outcome measures through an internal pilot trial of COTiD-UK compared with treatment as usual (TAU). •To estimate the effectiveness of COTiD-UK in improving the functional independence of people with mild to moderate dementia through a multicentre, pragmatic, single-blind, randomised controlled trial (RCT). •To evaluate cost-effectiveness of COTiD-UK compared with TAU. •To assess the implementation of COTiD-UK through monitoring and budget impact analysis. •To widely disseminate the findings of the Valuing Active Life in Dementia (VALID) research programme. The programme consisted of three phases, including five work packages (WPs): development (WP1 and WP2), piloting and evaluation (WP3 and WP4), and implementation (WP5). Development phase (work packages 1 and 2) Aim To translate and adapt the COTiD guideline and training package to optimise its suitability for use within the UK and, therefore, develop the COTiD-UK intervention ready for evaluation in WP3 and WP4. Method We used a mixed-methods approach, including the following activities. Work package 1: translation and adaptation This WP included the translation, expert review and adaptation of the manual and training materials used to train occupational therapists to deliver COTiD sessions to ‘pairs’ or dyads, comprising a person with mild to moderate dementia and their family carer; focus groups with occupational therapists who delivered COTiD, people with dementia and family carers who had not received COTiD; and semistructured interviews with pairs who had taken part in COTiD, managers of occupational therapists who delivered COTiD, and professionals who had referred pairs to receive COTiD. Finally, a consensus conference was held to finalise the content of the UK version of the intervention, COTiD-UK, with people with dementia and family carers, some of whom had participated in COTiD; occupational therapists who had received the training and delivered COTiD; and managers and other team members. Work package 2: survey of current practice This WP comprised an online survey collecting both quantitative and qualitative data from occupational therapists to scope current UK occupational therapy practice for people with dementia and their carers. Results Work package 1: translation and adaption We established a reference group of UK occupational therapists with experience of working with people with dementia and their family carers in practice. They provided expert opinion and guidance throughout the programme independent of the research team. This Occupational Therapy Reference Group reviewed the translated intervention and training materials, which were then adapted in consultation with the original author. We trained 44 occupational therapists from 10 organisations to deliver COTiD, of whom 28 took part in one of five focus groups. A total of 130 pairs took part in the COTiD sessions. We conducted semistructured interviews with nine pairs: four managers and five referrers. Thirty-nine people who had not received COTiD took part in one of six focus groups. Thirty-one people attended the consensus conference. Work package 2: survey of current practice A total of 230 occupational therapists consented to take part, of whom 197 (86%) provided quantitative data and 138 (60%) provided qualitative data also. Over half of the respondents undertook primarily profession-specific work. Occupational therapy-specific assessments were the most common profession-specific task, and the median time spent per person with dementia was 2.5 hours. Conclusion This phase took twice as long to complete as planned, partly because we underestimated the time needed to complete translation and partly because several organisational and governance issues delayed the occupational therapists delivering the intervention in practice, which in turn delayed the remainder of the data collection activities. We developed the COTiD-UK intervention ready for evaluation in WP3 and WP4. COTiD-UK retains the same aim and principles as COTiD, in that it aims to enable the person with dementia and family carer to carry out meaningful activities. This is achieved through adapting the environment and activity and coaching the family carer in problem-solving and supervision skills. It is similar to COTiD in that it comprises 10 hours of face-to-face intervention provided at home but is more flexible in content and delivery. For example, occupational therapists can use a wider range of assessment and intervention tools that are already in regular use within UK practice, and the time span for delivery is extended from 5 to 10 weeks to better meet the needs of pairs and be more feasible for service delivery. We restructured the training programme into 2 consecutive days followed by a third day once the therapists had delivered COTiD-UK in practice. We also used audio-recording rather than video-recording for the competence assessment process to better meet the needs of UK occupational therapists, many of whom had extensive experience of working with people living with dementia and their family carers or in the community. Piloting and evaluation phase (work packages 3 and 4) Aims Work package 3: internal pilot trial The aim of WP3 was to field test the outcome measures and trial procedures, and finalise the COTiD-UK intervention training, mode of delivery and supervision. Work package 4: full randomised controlled trial To estimate the clinical effectiveness and cost-effectiveness of COTiD-UK compared with TAU. Method We designed WP3 as an internal pilot trial with the intention of progressing to WP4, the full RCT, if it met predefined success criteria. The study design was a multicentre, two-arm, parallel-group, single-blind individually randomised pragmatic trial with an internal pilot. We allocated pairs at random between COTiD-UK and TAU, which 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 outcome measures were as follows: •for person with dementia – cognition (Mini Mental State Examination), ADL performance (Interview of Deterioration in Daily activities of Dementia), quality of life [Dementia Quality of Life (DEMQOL) scale] and mood (Cornell Scale for Depression in Dementia) •for the family carer – sense of competence (Sense of Competence Questionnaire), quality of life (DEMQOL scale) and mood (Hospital Anxiety and Depressions Scale) •for all participants – social contacts, leisure activities and serious adverse events. These outcomes were selected to reflect those measured in the previous trials of COTiD. We undertook a cost–utility analysis of the COTiD-UK intervention relative to TAU using costs and outcome data from the trial. Our analysis adopted the perspective of the NHS and Personal Social Services, as well as a societal perspective. The time horizon was 26 weeks, reflecting the trial’s primary end point. We assessed the effectiveness of the intervention in quality-adjusted life-years (QALYs) estimated from mortality and health-related quality-of-life data collected using the DEMQOL scale for carers, DEMQOL-Proxy for people with dementia and EuroQol-5 Dimensions, five-level version, and health and social care services used for both. We embedded two qualitative studies within the trial: •We explored the experience of undertaking the COTiD-UK intervention from the perspective of people with dementia, family carers and occupational therapists. We conducted semistructured interviews over the telephone with occupational therapists and face to face with pairs. We audio recorded and transcribed all interviews, checked them for accuracy, anonymised them and used inductive thematic analysis. •We explored why pairs declined to take part in the trial. We interviewed a convenience sample of carers identified during the screening process as being eligible but who subsequently declined to take part. We approached them only if we judged that it was unlikely to cause distress. We audio recorded and transcribed the telephone interviews, checked them for accuracy, anonymised them and used inductive thematic analysis. Results The independent Programme Steering Committee reviewed the internal pilot trial and agreed that we should carry the data collected to date forward to the main trial data set. We recruited 15 NHS trusts; however, one trust did not proceed to recruiting pairs owing to unforeseen service reorganisation that resulted in the occupational therapists whom we had trained no longer being available to take part. We trained 44 occupational therapists to deliver COTiD-UK, of whom 32 proceeded to the RCT and were allocated at least one pair each, although one was subsequently unavailable to provide the intervention as planned owing to ill health. We randomised 468 pairs: 249 to COTiD-UK and 219 to TAU. As we expected, the demographic and clinical characteristics of both groups were very similar at baseline. People with dementia ranged in age from 55 to 97 years, with a mean age of 78.6 years, and family carers ranged in age from 29 to 94 years, with a mean age of 69.1 years. The majority of people with dementia (74.8%) were married; 19.2% lived alone. Most family carers (72.6%) were spouses but 22.2% were adult children. At 26 weeks, 406 (87%) pairs remained in the trial. We collected and analysed outcome data from 368 (79%) pairs: 207 (83%) allocated to COTiD-UK and 161 (74%) allocated to TAU. At 26 weeks, there was no evidence to suggest a difference between the COTiD-UK and TAU groups in the primary outcome (BADLS score) or in any secondary outcome. Further analysis of BADLS scores and secondary outcomes at 52 and 78 weeks also showed no difference between the COTiD-UK and TAU groups. The non-adherence rate was 4.64%, compared with the target of 5%. The number of goals set per pair ranged from one to thirteen, with a mean of 4.09 goals. The total number of goals set was 920, of which 729 (79.24%) were achieved, 107 (11.63%) were partially achieved and 84 (9.13%) were not achieved. A total of 239 serious adverse events were recorded over the course of the trial, but none was assessed as being related to the COTiD intervention or trial participation. If decision-makers were willing to pay £20,000 (or £30,000) for a QALY, the probability that COTiD-UK is cost-effective would be 0.02% (or 0.04%). None of these statistical or economic findings changed when we re-ran analyses without adjustment or restricted to complete cases. Qualitative study 1 We interviewed seven occupational therapists and 22 pairs. We identified six themes from the occupational therapist interviews: (1) valuing the occupational focus of COTiD-UK, (2) timing and relationships, (3) achieving goals, (4) developing COTiD-UK knowledge and skills, (5) delivering COTiD-UK within current organisational models, and (6) delivering COTiD-UK in the future. We identified four themes from the interviews with people with dementia and their family carers: (1) achieving goals, (2) working together, (3) effect of dementia and (4) COTiD-UK outcomes. Qualitative study 2 We interviewed 10 family carers and identified two themes: (1) protectiveness and (2) ‘It’s not for us’. Conclusion This trial recruited 97.5% of the target sample, and attrition and non-adherence rates were low. Sites had fewer available occupational therapists than expected, and drop-out rates were higher than expected; therefore, we recruited more sites than originally planned, which took longer than expected. Our design required sites to access researchers, often from the local Clinical Research Network, to recruit participants and collect data, and occupational therapists to deliver the COTiD-UK intervention. Only 2 of the 15 trial sites acquired ‘excess treatment costs’, namely the additional funding that is required within the UK to deliver the clinical intervention being evaluated, as the research grant funding does not cover this. This inevitably reduced capacity to deliver the intervention in some sites because the occupational therapists’ availability was dependent on the goodwill of their managers, who had to balance their support for the study with the need to continue providing the usual service being commissioned. Hence, recruitment rates varied across sites, with some sites exceeding their recruitment target and more not achieving it. The trial statistical results showed no evidence that COTiD-UK was better than the usual care being provided, nor did the economic evaluation provide support for COTiD-UK. By contrast, many people with dementia and family carers described the intervention and its impact in very positive terms, providing examples of how they had resumed old activities and felt empowered to continue participation in future. Implementation phase (work package 5) This phase was amended in response to the cumulative delays outlined above, and the number of data already collected, taking into account the lack of statistically significant results and the growing body of implementation science knowledge. Aim The aims of this WP were to assess the intervention fidelity and to explore why the intervention was, or was not, delivered as planned. Methods We used a longitudinal observational design nested within the trial to assess fidelity to the COTiD-UK intervention. We audio-recorded as many COTiD-UK sessions as was feasible. We developed, piloted and refined fidelity checklists and coding until we achieved good agreement between coders. We purposively sampled 10% of sessions, and estimated percentages of components delivered for each session, occupational therapist and site. We reviewed data collected during the earlier development, piloting and evaluation phases using the theoretical domains framework to identify factors that enabled or hindered intervention delivery. Results A reliable measure of intervention fidelity was developed. Application of this measure found that COTiD-UK was delivered with moderate fidelity overall, although the mean range varied across sites and occupational therapists. The key domains affecting COTiD-UK implementation in practice were knowledge, skills (capability), environmental context and resources (opportunity) and beliefs about capabilities (motivation). Recommendations for future research Traditionally, psychosocial intervention research has focused on assessing outcomes such as cognition, daily living abilities and quality of life as core domains potentially impacted by dementia, using measures of deterioration and impairment. We noted that, in the main, pairs set goals relating to a wider range of activities than those covered within the BADLS, for example leisure, creative, social and community based. Given that over 90% of goals set by the dyads taking part in COTiD-UK were fully or partially achieved, further analysis of the goals set and met could inform the future selection and development of more meaningful occupational outcome measures, tools and processes. It is important to develop ways of measuring the outcomes of complex interventions, such as COTiD-UK, and to measure what is meaningful and prioritised by people with dementia and their family carers. There is also a need to develop such patient-related outcome measures in formats that make them suitable for self-report, to enable data to be collected directly from people with dementia themselves, in turn meaning researchers do not have to rely on proxy data. Implications for practice The trial statistical results did not indicate any benefit of the COTiD-UK intervention as delivered in this trial compared with usual care in the outcomes measured. However, the qualitative findings provided positive examples of dyads resuming or establishing meaningful activities. There is no evidence to suggest that occupational therapy input in general does not continue to be a highly valued and important part of multiprofessional teamworking and service provision. We therefore suggest that occupational therapists do not change their practice, but continue to contribute to community teamwork and memory service provision for people with cognitive problems and their families. Conclusion This applied research programme used a rigorous and thorough process to translate and adapt the original Dutch intervention to the UK version. We found no statistical evidence for clinical effectiveness or cost-effectiveness of COTiD-UK compared with the usual care provided. By contrast, people with dementia, family carers and occupational therapists provided positive examples of meaningful activities being resumed or established. We have shown that it is possible to conduct and effectively deliver a well-designed, high-quality, highly complex clinical trial of occupational therapy across 15 sites and requiring intervention delivery by experienced occupational therapists. Trial registration This trial was registered as ISRCTN10748953 (WP3 and WP4). Funding This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 11, No. 5. See the NIHR Journals Library website for further project information.

Antipsychotics are routinely prescribed to people diagnosed with schizophrenia or psychosis on a long-term basis. Considerable literature explores service users' opinions and experiences of antipsychotics, but studies investigating family members' views are lacking. To explore family members' perspectives on antipsychotics, particularly their views on long-term use, reduction and discontinuation of antipsychotics. Semi-structured interviews were conducted with 11 family members of people experiencing psychosis. Participants were recruited through community support groups and mental health teams. Interviews were analysed thematically. The majority of family members valued antipsychotic medication primarily in supporting what they saw as a fragile stability in the person they cared for. Their views of medication were ambivalent, combining concerns about adverse effects with a belief in the importance of medication due to fears of relapse. They described a need for constant vigilance in relation to medication to ensure it was taken consistently, and often found changes, particularly reduction in medication difficult to contemplate. Findings highlight that family members' attitudes to medication sometimes conflict with those of the people they care for, impacting on their health and the caring relationship. Family members may need more support and could be usefully involved in medication decision-making. [ABSTRACT FROM AUTHOR]

Background:Caregiver efficacy for managing the behavioral and psychological symptoms of dementia (BPSD) is an important determinant of family caregiver stress and burden. This study aims to develop a measure of caregiver efficacy for responding to BPSD and to evaluate its psychometric properties.Methods:The Caregiver Efficacy Scale adds an item for caregiver confidence in managing BPSD to each domain of the Neuropsychiatric Inventory (NPI). The validity, internal consistency, and factor structure of the scale were evaluated in 245 family caregivers.Results:The results provide adequate support for the validity and reliability of the Caregiver Efficacy Scale. The internal consistency was found to be adequate (Cronbach's α = 0.79) and the scale demonstrated good concurrent, construct, and criterion validity. As expected, performance on the Caregiver Efficacy Scale was associated with all dimensions of the NPI, including BPSD frequency (r = 0.869, p < 0.01) and severity (r = 0.883, p < 0.01), and negative outcomes, including negative affect (r = 0.411, p < 0.01), depression (r = 0.362, p < 0.01), anxiety (r = 0.376, p < 0.01), and distress (r = 0.865, p < 0.01).Conclusions:The Caregiver Efficacy Scale might have clinical implications in facilitating the development of improved caregiver interventions for dealing with BPSD, allowing interventions to be tailored according to individual caregiver needs, and also in evaluating the effectiveness of interventions aimed at improving caregiver self-efficacy for managing BPSD. [ABSTRACT FROM AUTHOR]

Objective Recent reviews on music therapy for people with dementia have been limited to attempting to evaluate whether it is effective, but there is a need for a critical assessment of the literature to provide insight into the possible mechanisms of actions of music therapy. This systematic review uses a narrative synthesis format to determine evidence for effectiveness and provide insight into a model of action. Method The narrative synthesis framework consists of four elements: (i) theory development; (ii) preliminary synthesis of findings; (iii) exploration of relationships between studies; and (iv) assessment of the robustness of the synthesis. Results Electronic and hand searches identified 263 potentially relevant studies. Eighteen studies met the full inclusion criteria. Three distinctive strands of investigations emerged: eight studies explored behavioural and psychological aspects, five studies investigated hormonal and physiological changes, and five studies focused on social and relational aspects of music therapy. The musical interventions in the studies were diverse, but singing featured as an important medium for change. Conclusions Evidence for short-term improvement in mood and reduction in behavioural disturbance was consistent, but there were no high-quality longitudinal studies that demonstrated long-term benefits of music therapy. Future music therapy studies need to define a theoretical model, include better-focused outcome measures, and discuss how the findings may improve the well-being of people with dementia. Copyright © 2012 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: Many people with a psychosis diagnosis have significant impairments in their social functioning. Despite this, long standing lack of consensus exists in the definition of social functioning in psychosis. Efforts to evaluate interventions for social functioning are hampered by measurement difficulties, and comparing interventions is difficult. Popular measures of social functioning vary widely, both conceptually and methodologically, and it is unclear how meaningful they are for service users. With the increasing development and evaluation of social interventions for psychosis and the boom in the development of measures, this paper reviews the recently developed measures of social functioning. It aggregates how often and in which studies measures have been used, the concepts and theories that underlie them, as well as assessing their quality across a number of indicators, with a particular focus on how patient-centred they are. Methods: Systematic review and narrative synthesis. Results: 21 new measures of social functioning were identified, of low to moderate quality. The content, definitions, theories and domains will be discussed, as well as a discussion of changes in the construct over time. Discussion will include the development of measures for use in first episode psychosis, measures with a focus on negative symptoms and the increasing use of technology in the assessment of social functioning. Discussion: Many measures exist for assessing social functioning in psychosis, of variable quality. Further attention should be directed to psychometric evaluation and ensuring service user involvement in development [ABSTRACT FROM AUTHOR]