Pip Logan

Background: HomeHealth is a home-based, voluntary sector service supporting older people with mild frailty to maintain independence through behaviour change. Support workers discuss the person’s priorities and enable setting/achieving goals around mobility, nutrition, socialising and/or psychological well-being. Aims: We tested clinical and cost-effectiveness of HomeHealth for maintaining independence in older people with mild frailty in a randomised controlled trial. Methods: Design: Single-blind, parallel randomised controlled trial open between 18 January 2021 and 4 July 2023, with mixed-methods process evaluation. Setting: Community-dwelling older people aged 65+ years with mild frailty from 27 general practices and community settings in London, Yorkshire and Hertfordshire. Randomisation: Participants were randomised 1 : 1 to receive HomeHealth or treatment as usual. Outcomes: Primary outcome was independence in activities of daily living (modified Barthel Index), analysed using linear mixed models. Secondary outcomes included frailty phenotype score, extended activities of daily living, well-being, psychological distress, loneliness, cognition, falls and mortality. Health economic outcomes included quality of life, capability and service use, including hospital admissions. Cost-effectiveness acceptability curves and cost-effectiveness planes were used to represent the probability of cost-effectiveness compared to treatment as usual. Process evaluation: We conducted semistructured interviews with participants receiving the intervention, HomeHealth workers and other stakeholders supporting service delivery. Interviews were thematically analysed. Fidelity of audio-recorded appointments was assessed by two independent raters. We evaluated potential mechanisms of impact using data from appointments attended, types of goals set and progress towards goals. Findings: We recruited 388 participants, mean age 81.4 years (standard deviation 6.5), 64% female and 94% White British/European. HomeHealth did not improve Barthel Index scores at 12 months (0.250, 95% confidence interval −0.932 to 1.432). At 6 months, we found small significant reductions in psychological distress (−1.237, 95% confidence interval −2.127 to −0.348), and frailty phenotype score (−0.252, 95% confidence interval −0.487 to −0.017). At 12 months, we found significant improvements in well-being (1.449, 95% confidence interval 0.124 to 2.775), reduced unplanned admissions (incidence rate ratio 0.65, 95% confidence interval 0.54 to 0.92) with lower associated costs (−£586/participant, 95% confidence interval −351 to −821). There were no differences in other outcomes. HomeHealth dominates treatment as usual with a negative point estimate for incremental costs (−796, 95% confidence interval −2016 to 424), positive point estimate for incremental quality-adjusted life-years (0.009, −0.021 to 0.039) and high probability of cost-effectiveness. Process evaluation: Sixty-four semistructured interviews were completed, including 49 participants and 15 HomeHealth workers/stakeholders. The service was acceptable and safe, with good fidelity of delivery. Participants made progress on personalised goals, most working on enhancing mobility. They found the service empowering, and received emotional/practical support. Engagement was more challenging when participants identified no need for change, had significant memory impairment or new/declining illness. Flexibility around varying symptoms and incorporating behaviour change into existing routines promoted engagement. Conclusion: HomeHealth did not improve independent functioning for older people with mild frailty. There were small significant improvements in frailty status, psychological distress and well-being and a 35% reduction in unplanned admissions, with high probability of cost-effectiveness. Limitations: We used a pragmatic design with intervention delivery in real-world settings during/after the COVID-19 pandemic, potentially with more variability in delivery. Our findings might not apply to other geographical settings/healthcare systems. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR128334.

Background: Dementia represents a major public health challenge worldwide. Interventions are required to maintain functional ability and prevent crises. Exercise-based therapy may improve activities of daily living and prevent falls. Objective: We aimed to systematically develop an intervention, called Promoting Activity, Independence and Stability in Early Dementia and mild cognitive impairment (PrAISED), and evaluate its clinical and cost-effectiveness. Design: A mixed-methods study. Literature review, co-design, patient and public involvement and practical experience were used to develop and refine a therapy intervention. We applied principles of behaviour change to promote engagement and motivation. Three-arm feasibility randomised controlled trial to test research procedures, the practicality of intervention, and establish the need for prolonged supervision. Two-arm, multicentre randomised controlled trial, comparing intervention with control, with 15 months’ follow-up. Process and realist evaluations, including quantitative data, interviews and thematic analyses. Health economic evaluations, including a cost-effectiveness analysis using Markov modelling and social return on investment. Implementation study. Setting: Therapy and research were undertaken in participants’ homes and local communities across 5 sites in England. Participants: People with diagnosed mild dementia or mild cognitive impairment, Montreal Cognitive Assessment score 13–25, living at home and a family member or carer. In the main trial, there were five sites in England, participants were 98% White ethnicity and 20% had mild cognitive impairment. Interventions: A specially designed, dementia-specific, rehabilitation programme focusing on strength, balance, physical activity and performance of activities of daily living, which was tailored, progressive and addressed risk, providing up to 50 therapy sessions over 12 months. The control group received usual care plus a falls risk assessment. Main outcome measures: The primary trial outcome was the informant-reported Disability Assessment for Dementia 12 months after randomisation. Secondary outcomes were: self-reported activities of daily living, physical activity, quality of life, frailty, balance, functional mobility, cognition, fear of falling, mood, carer strain and service use (at 12 months) and falls (between months 4 and 15). Results: Three hundred and sixty-five people were randomised in the multicentre trial, 183 to intervention and 182 to control. Median age of participants was 80 years (range 65–95), median Montreal Cognitive Assessment score was 20/30 (range 13–26) and 58% were men. Participants received a median of 31 (interquartile range = 22–40) therapy sessions out of a possible maximum of 50. Participants reported completing a mean 121 minutes/week of PrAISED activity. Primary outcome data were available for 149 (intervention) and 141 (control) participants. There was no difference in Disability Assessment for Dementia scores between groups: adjusted mean difference −1.3/100, 95% confidence interval (−5.2 to 2.6); Cohen’s d effect size −0.06 (−0.26 to 0.15); p = 0.5. Upper 95% confidence intervals excluded small to moderate effects on any secondary outcome measures. Between months 4 and 15, there were 79 falls in the intervention group and 200 falls in the control group, and adjusted incidence rate ratio was 0.78 (0.5 to 1.3); p = 0.3. Participants and therapists liked the intervention and thought that it produced health benefits. Tailoring, perceiving benefits, professional supervision and family or carer support were important facilitators. Cognitive and physical impairment, risk aversion and tapering the level of support were barriers. Therapeutic relationship between participant and therapist was important. The cost per quality-adjusted life-year gained was £130,000 over a lifetime horizon. Social return on investment was positive before the onset of the COVID-19 pandemic but was negative after the first pandemic lockdown, largely due to unavailability of access to community facilities. Limitations: The multicentre randomised controlled trial was disrupted by the COVID-19 pandemic. The first lockdown occurred when 301 participants had been randomised and 64 participants had completed the trial. Recruitment was suspended, and some therapy and data collection were undertaken remotely. The intervention was diminished compared with in-person delivery, but reported fidelity remained reasonable. Our participant population lacked socioeconomic and ethnic diversity – over 30% lived in the least deprived decile of postcodes. The intervention was very popular with participants and therapists, and it is possible that our predominantly biomedical and functionally orientated outcome variables failed to capture intervention benefits. Conclusions: The intensive PrAISED programme of exercise and functional activity training did not improve activities of daily living, physical activity, quality of life, reduce falls or improve any other secondary health status outcomes. Due to the pandemic, the population recruited, and the outcomes chosen, some uncertainty remains about the effectiveness of the intervention. Future work: Consider: (1) repeating the trial outside of a pandemic; (2) more psychosocial outcomes, such as social participation, affirming personhood and valuing therapeutic relationships; (3) alternative approaches to risk reduction and ability maintenance in dementia; (4) other models of support to manage problems associated with inevitable progression and decline; (5) that conventional randomised controlled trials may not be the best way to evaluate complex intervention for complex and degenerative conditions; interpretative and realist methods should supplement evaluation; and (6) work to include a wider range of ethnicities and socioeconomic circumstances. Study registration: This study is registered as ISRCTN10550694, 15320670. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-0614-20007) and is published in full in Programme Grants for Applied Research ; Vol. 14, No. 1. See the NIHR Funding and Awards website for further award information.

Background: Coronavirus disease-2019 was associated with significant mortality and morbidity in care homes in 2020–1. Repurposed antiviral drugs might reduce morbidity and mortality through reducing viral transmission, infection, replication and inflammation. We aimed to compare the safety and efficacy of potential antiviral drugs in care home residents. Methods: We designed a cluster-randomised, open-label, blinded end-point platform trial to test drugs in a postexposure prophylaxis paradigm. Participants aged 65+ years from United Kingdom care homes, with or without nursing, were eligible for participation. Care homes were to be allocated at random by computer to administer 42 days of antiviral agent (ciclesonide or niclosamide) plus standard care versus standard care alone to residents. The primary outcome at 60 days after randomisation comprised the most serious outcome, which was defined as all-cause mortality, all-cause hospitalisation, severe acute respiratory syndrome coronavirus 2 infection or no infection. Analysis would be by intention to treat using ordinal logistic regression. Other outcomes included individual components of the primary outcome, transmission, plus health economic and process evaluation outcomes. The planned sample size was 300 care homes corresponding to 9600 residents. With ~40% of care homes predicted to develop an outbreak during the trial, we needed to recruit 750 homes/24,000 residents. Results: We initiated the trial including protocol, approvals, insurance, website, database, data algorithms, intervention selection and training materials. We built a network of principal investigators and staff (91) and care homes (299) to support the trial. However, we never contracted care homes or general practitioners since the trial was stopped in September 2021, as vaccination in care homes had significantly reduced infections. Multiple delays significantly delayed the start date, such as: (1) reduced prioritisation of pandemic trials in 2021; (2) cumbersome mechanisms for choosing the investigational medicinal products; (3) contracting between National Institute for Health and Care Research and the investigational medicinal product manufacturers; (4) publicising the investigational medicinal products; (5) identification of sufficient numbers of care homes; (6) identification and contracting with several thousand general practitioners; (7) limited research nurse availability and (8) identification of adequate insurance to cover care homes for research. Generic challenges included working across the four home nations with their different structures and regulations. Limitations: The feasibility of contracting between the sponsor and the principal investigators, general practitioners and care homes; screening, consent and treatment of care home residents; data acquisition and the potential benefit of postexposure prophylaxis were never tested. Conclusions: The success of vaccination meant that the role of postexposure prophylaxis of coronavirus disease-2019 in care home residents was not tested. Significant progress was made in developing the infrastructure and expertise necessary for a large-scale clinical trial of investigational medicinal products in United Kingdom care homes. Future work: The role of postexposure prophylaxis of coronavirus disease-2019 in care home residents remains undefined. Significant logistical barriers to conducting research in care homes need to be removed urgently before future studies are possible. Further work is required to develop the infrastructure for clinical trials of investigational medicinal products in care homes. Serious consideration should be given to building and then hibernating a pandemic-ready platform trial suitable for care home research. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR133443.

Background: Complications due to frailty and injury after falls are a significant problem for people living in residential aged care. This can lead to a range of negative outcomes including poor physical, social, and psychological well-being. The Australian Royal Commission into Aged Care Quality and Safety highlighted many aspects of care in residential aged care homes requiring improvement, leading to specific recommendations aimed at improving the outcomes in this area. This contributed to four recommendations calling for increased allied health interventions to meet the unmet needs in residential aged care. This intervention aims to implement and evaluate evidence-based allied health interventions for people living in residential aged care specifically relating to frailty, preventing falls, and maintaining engagement in everyday activities. Method: This is a pragmatic, non-randomised, pre–post design study where six groups of up to 10 residents of an aged care home will start the intervention at staggered times. The EAHOP intervention is an integrated application of a suite of allied health services (occupational therapy, physiotherapy, dietetics, speech pathology, pharmacy, and optometry), with general practitioner involvement, using allied health assistants in an integrated transdisciplinary model of care. The baseline period is 6 weeks, and intervention is a maximum of 36 weeks with follow-up at 12 and 24 weeks. Primary outcomes measure changes in falls, frailty, and quality of life. A qualitative program evaluation will be completed as well as an economic analysis. Conclusion: The results of the study will provide information about the clinical, implementation, and effectiveness outcomes of this integrated, transdisciplinary allied health service model for people living in residential aged care. The results will be used to develop evidence-informed guidelines for residential aged care providers on the delivery of allied health services.

Background: People living in care homes often have problems with pain, anxiety and depression. Whether being on analgesia, anxiolytics or antidepressants has any bearing on pain severity and quality of life (QoL) in this population, requires further investigation.Objectives: (i) to examine the relationship between pain, anxiety and depression and medication use in care home residents and (ii) to compare those on medications to treat pain, anxiety and depression, and those who were not, and associations with pain severity and overall QoL.Methods: This was a secondary analysis of a randomised controlled trial testing a falls prevention intervention in care homes. We recorded pain, anxiety and depression, QoL measurements and prescribed medication use.Results: In 1589 participants, the mean age was 84.7 years (±9.3 SD), 32.2% were male and 67.3% had a diagnosis of dementia. 54.3% and 53.2% of participants had some level of pain and anxiety or depression respectively, regardless of prescribed medication use. There was a direct association between pain severity and being on any analgesia, opioid analgesia, and antidepressants, but no associations between pain severity and use of paracetamol and anxiolytics. QoL was best for residents with no pain and not on any analgesia, anxiolytics or antidepressants and worst for those with moderate-extreme pain and taking at least two of these classes of medications.Conclusion: Many care home residents live with pain, anxiety and depression. Addressing residents’ pain may also increase their quality of life, but using medication alone to reach this goal may be inadequate.

Introduction. Dementia‐friendly communities coordinate activities and events which offer social inclusion and participation of people with dementia. Initiatives can include memory cafés, sports, and tourist and heritage visits. This study explored how dementia‐friendly initiatives are developed and sustained in England, drawing comparisons with an equivalent case study in the Netherlands. Methods. We present a case study of dementia‐friendly initiatives, in one city in England. Selection of this case study was done on the basis of being a leading dementia‐friendly community. We interviewed a variety of stakeholders, including people with dementia and their care partners, volunteers, and staff. Semistructured interviews were recorded, and transcripts were analysed using qualitative analysis software using a realist evaluation interpretation. Realist theories described within this English case study were compared with those described within the Dutch case studies. Findings. Five context mechanism outcome configurations were described. The Dementia Action Alliance for the city was a coordinator of initiatives and provided funding and resources. The alliance facilitated advocates to partner with organisations with a shared commitment to plan activities. On the level of individual interactions, staff or volunteers were involved in communicating with local community members, which may lead to improvement in awareness. Initiatives had various ways to listen and incorporate the views of people with dementia. The five mechanisms identified within the English case study resonated with the mechanisms identified within the larger Dutch case study, with differences in contexts due to local policies and practices. Conclusion. Strategic coordination is an important factor for development and sustainability. The national policy in England has set the pattern for local structures, while the Dutch approach is “bottom‐up” with local leadership. Community advocates and public support were important factors in the development of dementia‐friendly initiatives in both countries.

Background: Therapeutic exercise is commonly used by healthcare professionals to support people recovering from injury or illness. There is little guidance on how to personalise these standardised programmes for people living with dementia (PLWD). The Movement with Dementia resource was co‐designed by PLWD, exercise instructors and healthcare professionals to address this knowledge gap. The aim of this study was to explore the feasibility and usability of implementing the Movement with Dementia shared decision‐making resource to assist prescribers and deliverers of therapeutic exercise interventions for PLWD.Method: A single site, non‐blinded feasibility study was conducted with an NHS community therapy team and their patients living with dementia. Eligibility criteria were people with a diagnosis of dementia, prescribed and undertaking an exercise programme as part of their care by the therapy team, able to provide consent and participate in the shared decision‐making process.Therapist participants undertook training (2‐hr session) on the Movement with Dementia resource and asked to use it during prescription and delivery of exercise with the patient participants, as part of their care episode. Questionnaires recorded demographic and usability information from all participants.Result: Between January and March 2023 we recruited 9 therapist and 6 patient participants. Four physiotherapists (100% female; mean age = 39yrs) and six patient participants (50% female; mean age = 81yrs) completed the questionnaires. Patient participants had various dementia diagnoses (n = 1 AD, n = 3 VD, n = 1 LBD, n = 1 unsure), all were white‐British, and most lived with others (n = 4).None of the patient participants could recall using the resource, but 83% (n = 5) were still undergoing active care. All therapist participants were ‘likely’ or ‘very likely’ to recommend it but found the current material too ‘wordy’, both for themselves and PWLD. Whilst it reinforced knowledge and provided supportive ‘prompts’ for their approach, it was recommended for those with less experience treating PLWD.Conclusion: The co‐designed Movement with Dementia resource was successfully implemented into a clinical setting to support therapists prescribing and delivering exercise programmes for PLWD. Further refinement is required before wider evaluation and implementation. A focus on supporting therapists with less experience treating PLWD will direct future study.

Background and Objectives: Post-Stroke Fatigue (PSF) is a complex, multidimensional, debilitating condition that affects almost half of all stroke survivors. This study explored the perceptions of physiatrists, physiotherapists, and occupational therapists about PSF and their experiences in managing patients with PSF in Saudi Arabia. Materials and Methods: Qualitative semi-structured interviews were conducted with participants from three different groups: eight physiotherapists (PTs), eight occupational therapists (OTs), and eight physiatrists (DRs). Using purposive sampling, participants with at least one year of experience in the field of PSF management were invited to take part. The data were analysed using inductive thematic analysis. Results: Twenty-four health care participants (eight PTs, eight OTs, eight DRs) were recruited. Five overarching themes encompassing various subthemes and sub-subthemes were generated: ‘knowledge about post-stroke fatigue’, ‘diagnosing post-stroke fatigue’, ‘treatment approach’, ‘lack of awareness about post-stroke fatigue’, and ‘domains to improve’. The data indicated that participants used various strategies to manage PSF, including dietary changes, sleep hygiene, exercise, and energy conservation. Conclusions: Participants acknowledged that they lacked PSF-related management skills, despite possessing adequate knowledge about the management of stroke. Their openness to participating in activities that would improve their ability to diagnose and manage PSF was particularly striking.

Objectives This study aims to illuminate the perspectives of informal caregivers who support people following hip fracture surgery. Design A qualitative study embedded within a now completed multicentre, feasibility randomised controlled trial (HIP HELPER). Setting Five English National Health Service hospitals. Participants We interviewed 20 participants (10 informal caregivers and 10 people with hip fracture), following hip fracture surgery. This included one male and nine females who experienced a hip fracture; and seven male and three female informal caregivers. The median age was 72.5 years (range: 65–96 years), 71.0 years (range: 43–81 years) for people with hip fracture and informal caregivers, respectively. Methods Semistructured, virtual interviews were undertaken between November 2021 and March 2022, with caregiver dyads (person with hip fracture and their informal caregiver). Data were analysed thematically. Findings We identified two main themes: expectations of the informal caregiver role and reality of being an informal caregiver; and subthemes: expectations of care and services; responsibility and advocacy; profile of people with hip fracture; decision to be a caregiver; transition from hospital to home. Conclusion Findings suggest informal caregivers do not feel empowered to advocate for a person’s recovery or navigate the care system, leading to increased and unnecessary stress, anxiety and frustration when supporting the person with hip fracture. We suggest that a tailored information giving on the recovery pathway, which is responsive to the caregiving population (ie, considering the needs of male, younger and more active informal caregivers and people with hip fracture) would smooth the transition from hospital to home. Trial registration number ISRCTN13270387.Cite Now