BackgroundVisually impaired older people (VIOP) have a higher risk of falling than their sighted peers, and are likely to avoid physical activity. The aim was to adapt the existing Falls Management Exercise (FaME) programme for VIOP, delivered in the community, and to investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of this adapted intervention.MethodsTwo-centre randomised mixed methods pilot trial and economic evaluation of the adapted group-based FaME programme for VIOP versus usual care. A one hour exercise programme ran weekly over 12 weeks at the study sites (Newcastle and Glasgow), delivered by third sector (voluntary and community) organisations. Participants were advised to exercise at home for an additional two hours over the week. Those randomised to the usual activities group received no intervention.Outcome measures were completed at baseline, 12 and 24 weeks. The potential primary outcome was the Short Form Falls Efficacy Scale – International (SFES-I).Participants’ adherence was assessed by reviewing attendance records and self-reported compliance to the home exercises. Adherence with the course content (fidelity) by instructors was assessed by a researcher. Adverse events were collected in a weekly phone call.ResultsEighteen participants, drawn from community-living VIOP were screened; 68 met the inclusion criteria; 64 participants were randomised with 33 allocated to the intervention and 31 to the usual activities arm.94% of participants provided data at the 12 week visit and 92% at 24 weeks. Adherence was high. The intervention was found to be safe with 76% attending nine or more classes. Median time for home exercise was 50 min per week.There was little or no evidence that fear of falling, balance and falls risk, physical activity, emotional, attitudinal or quality of life outcomes differed between trial arms at follow-up.ConclusionsThe intervention, FaME, was implemented successfully for VIOP and all progression criteria for a main trial were met. The lack of difference between groups on fear of falling was unsurprising given it was a pilot study but there may have been other contributory factors including suboptimal exercise dose and apparent low risk of falls in participants. These issues need addressing for a future trial.Trial registrationCurrent Controlled Trials ISRCTN ID: 16949845 Registered: 21 May 2015.

Background In the UK, most people with dementia die in the community and they often receive poorer end-of-life care than people with cancer. Objective The overall aim of this programme was to support professionals to deliver good-quality, community-based care towards, and at, the end of life for people living with dementia and their families. Design The Supporting Excellence in End-of-life care in Dementia (SEED) programme comprised six interlinked workstreams. Workstream 1 examined existing guidance and outcome measures using systematic reviews, identified good practice through a national e-survey and explored outcomes of end-of-life care valued by people with dementia and family carers (n = 57) using a Q-sort study. Workstream 2 explored good-quality end-of-life care in dementia from the perspectives of a range of stakeholders using qualitative methods (119 interviews, 12 focus groups and 256 observation hours). Using data from workstreams 1 and 2, workstream 3 used co-design methods with key stakeholders to develop the SEED intervention. Worksteam 4 was a pilot study of the SEED intervention with an embedded process evaluation. Using a cluster design, we assessed the feasibility and acceptability of recruitment and retention, outcome measures and our intervention. Four general practices were recruited in North East England: two were allocated to the intervention and two provided usual care. Patient recruitment was via general practitioner dementia registers. Outcome data were collected at baseline, 4, 8 and 12 months. Workstream 5 involved economic modelling studies that assessed the potential value of the SEED intervention using a contingent valuation survey of the general public (n = 1002). These data informed an economic decision model to explore how the SEED intervention might influence care. Results of the model were presented in terms of the costs and consequences (e.g. hospitalisations) and, using the contingent valuation data, a cost–benefit analysis. Workstream 6 examined commissioning of end-of-life care in dementia through a narrative review of policy and practice literature, combined with indepth interviews with a national sample of service commissioners (n = 20). Setting The workstream 1 survey and workstream 2 included services throughout England. The workstream 1 Q-sort study and workstream 4 pilot trial took place in North East England. For workstream 4, four general practices were recruited; two received the intervention and two provided usual care. Results Currently, dementia care and end-of-life care are commissioned separately, with commissioners receiving little formal guidance and training. Examples of good practice rely on non-recurrent funding and leadership from an interested clinician. Seven key components are required for good end-of-life care in dementia: timely planning discussions, recognising end of life and providing supportive care, co-ordinating care, effective working with primary care, managing hospitalisation, continuing care after death, and valuing staff and ongoing learning. Using co-design methods and the theory of change, the seven components were operationalised as a primary care-based, dementia nurse specialist intervention, with a care resource kit to help the dementia nurse specialist improve the knowledge of family and professional carers. The SEED intervention proved feasible and acceptable to all stakeholders, and being located in the general practice was considered beneficial. None of the outcome measures was suitable as the primary outcome for a future trial. The contingent valuation showed that the SEED intervention was valued, with a wider package of care valued more than selected features in isolation. The SEED intervention is unlikely to reduce costs, but this may be offset by the value placed on the SEED intervention by the general public. Limitations The biggest challenge to the successful delivery and completion of this research programme was translating the ‘theoretical’ complex intervention into practice in an ever-changing policy and service landscape at national and local levels. A major limitation for a future trial is the lack of a valid and relevant primary outcome measure to evaluate the effectiveness of a complex intervention that influences outcomes for both individuals and systems. Conclusions Although the dementia nurse specialist intervention was acceptable, feasible and integrated well with existing care, it is unlikely to reduce costs of care; however, it was highly valued by all stakeholders (professionals, people with dementia and their families) and has the potential to influence outcomes at both an individual and a systems level. Future work There is no plan to progress to a full randomised controlled trial of the SEED intervention in its current form. In view of new National Institute for Health and Care Excellence dementia guidance, which now recommends a care co-ordinator for all people with dementia, the feasibility of providing the SEED intervention throughout the illness trajectory should be explored. Appropriate outcome measures to evaluate the effectiveness of such a complex intervention are needed urgently. Trial registration Current Controlled Trials ISRCTN21390601. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research, Vol. 8, No. 8. See the NIHR Journals Library website for further project information.

Background The visually impaired have a higher risk of falling and are likely to avoid activity. Objectives To adapt the existing Falls Management Exercise (FaME) programme, which is delivered in the community, for visually impaired older people (VIOP) and to investigate the feasibility of conducting a definitive randomised controlled trial of this adapted intervention. Design Phase I – consultation with stakeholders to adapt the existing programme. Two focus groups were conducted, each with 10 VIOP across the study sites. Phase II – two-centre randomised pilot trial and economic evaluation of the adapted programme for VIOP versus usual care. Phases III and IV – qualitative interviews with VIOP and Postural Stability Instructors regarding their views and experiences of the research process, undertaking the intervention and its acceptability. Intervention This was adapted from the group-based FaME programme. A 1-hour exercise programme ran weekly over 12 weeks at the study sites (Newcastle upon Tyne and Glasgow) and was delivered by third-sector organisations. Participants were advised to also exercise at home for 2 hours per week. Those randomised to the usual activities group received no intervention. Outcome measures These were completed at baseline, week 12 and week 24. The primary potential outcome measure used was the Short Form Falls Efficacy Scale – International. Secondary outcome assessment measures were activity avoidance, current activity, balance/falls risk, physical activity, loneliness, anxiety and depression, work and social adjustment, quality of life and economic costs. Participants’ compliance was assessed by reviewing attendance records and self-reported compliance with the home exercises. Instructors’ compliance with the course content (fidelity) was assessed by a researcher attending a sample of exercise sessions. Adverse events were collected in a weekly telephone call for all participants in both the intervention and control arm. Findings An adapted exercise programme was devised with stakeholders. In the pilot trial, 82 participants drawn from community-living VIOP were screened, 68 met the inclusion criteria and 64 were randomised, with 33 allocated to the intervention and 31 to the usual activities arm. A total of 94% of participants provided data at week 12 and 92% at week 24. Adherence to the study was high. The intervention was found to be both safe and acceptable to participants, with 76% attending nine or more classes. Median time for home exercise was 50 minutes per week. There was little or no evidence that fear of falling, exercise, attitudinal or quality-of-life outcomes differed between trial arms at follow-up. Thematic analysis of the interviews with VIOP participants identified facilitators of and barriers to exercise, including perceived relevance to health, well-being and lifestyle, social interaction, self-perception and practical assistance. Instructors identified issues regarding level of challenge and assistance from a second person. Limitations The small sample size and low falls risk of the study sample are study limitations. Conclusion Although adaptation, recruitment and delivery were successful, the findings (particularly from qualitative research with instructors and participants) indicated that VIOP with low to moderate falls risk could be integrated into mainstream programmes with some adaptations. A future definitive trial should consider graduated exercises appropriate to ability and falls risk within mainstream provision. Other outcome measures may additionally be considered. Trial registration Current Controlled Trials ISRCTN16949845. Funding This project was funded by the NIHR Public Health Research programme and will be published in full in Public Health Research; Vol. 7, No. 4. See the NIHR Journals Library website for further project information.

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DA 2019, 'Views and experiences of visually impaired older people and exercise instructors about the Falls Management Exercise programme: a qualitative study', Disability and Rehabilitation.