Enabling health and maintaining independence for older people at home (HomeHealth trial): a multicentre randomised controlled trial.

BACKGROUND: NHS frailty services commonly target more severely frail older people, despite evidence suggesting frailty can be prevented or reversed when addressed at an earlier stage. HomeHealth is a new home-based, manualised voluntary sector service supporting older people with mild frailty to maintain their independence through behaviour change. Over six appointments, a trained HomeHealth worker discusses what matters to the older person and supports them to set and achieve goals around mobility, nutrition, socialising and/or psychological wellbeing. The service showed promising effects in a feasibility trial. We aimed to test the clinical and cost-effectiveness of HomeHealth for maintaining independence in older people with mild frailty compared with treatment as usual. METHODS: In this single-blind multicentre randomised controlled trial, we recruited community-dwelling older people aged 65 years or older with mild frailty from 27 general practices, community groups and sheltered housing in London, Yorkshire, and Hertfordshire. Participants were randomly assigned (1:1) to receive either HomeHealth monthly for 6 months or treatment as usual (usual GP and outpatient care, no specific frailty services). Our primary outcome was independence in activities of daily living, measured by blinded outcome assessors using the modified Barthel Index, and analysed using linear mixed models, including 6-month and 12-month data and controlling for baseline Barthel score and site. The study was approved by the Social Care Research Ethics Committee, and all participants provided written or orally recorded informed consent. This study is registered with the ISRCTN registry, ISRCTN54268283. FINDINGS: This trial took place between Jan 18, 2021, and July 4, 2023. We recruited 388 participants (mean age 81·4 years; 64% female [n=250], 94% White British/European [n=364], 2·5% Asian [n=10], 1·5% Black [n=6], 2·0% other [n=8]). We achieved high retention for 6-month follow-up (89%, 345/388), 12-month follow-up (86%, 334/388), and medical notes data (89%, 347/388). 182 (93%) of 195 participants in the intervention group completed the intervention, attending a mean of 5·6 appointments. HomeHealth had no effect on Barthel Index scores at 12 months (mean difference 0·250, 95% CI -0·932 to 1·432). At 6 months, there was a small reduction in psychological distress (-1·237, -2·127 to -0·348) and frailty (-0·124, -0·232 to -0·017), and at 12 months, we found small positive effects on wellbeing (1·449, 0·124 to 2·775) in those receiving HomeHealth. Other outcomes in analysis to date showed no significant difference. Health economic outcomes (including quality of life, capability, health services use and care needs or burden) are pending. INTERPRETATION: This high-quality trial showed that HomeHealth did not maintain independence in older people with mild frailty, and had limited effects upon secondary outcomes. Future studies need to explore different ways to promote health in this population. FUNDING: National Institute for Health and Care Research Health Technology Assessment (NIHR HTA).

The effect of early mobilisation (< 14 days) on pathophysiological and functional outcomes in animals with induced spinal cord injury: a systematic review with meta-analysis.

INTRODUCTION: The optimum time to mobilise (standing, walking) following spinal cord injury (SCI) is unknown but may have implications for patient outcomes. There are no high-quality experimental studies that examine this issue, with a paucity of guidance for clinicians. Pre-clinical studies lead research in this field and can contribute to knowledge and support future clinical practice. OBJECTIVE: to evaluate the effect of early compared to no mobilisation on pathophysiological and functional outcomes in animals with induced SCI. METHODS: A systematic review with meta-analysis was conducted by searching pre-clinical literature in MEDLINE (PubMed), Embase (Ovid), Web of Science, OpenGrey, and EThOS (June 2023). Studies were included of any research method giving numerical results comparing pathophysiological and functional outcomes in rats and mice mobilised within 14-days of induced SCI to those that did not mobilise. Data were synthesised using random-effects meta-analyses. The quality of the evidence was assessed using the CAMARADES checklist. The certainty of findings was reported using the GRADE approach. This study is registered on PROSPERO (CRD42023437494). RESULTS: Seventeen studies met the inclusion criteria. Outcomes found that Brain Derived Neurotrophic Factor levels were greater in those that initiated mobilisation within 14-days of SCI compared to the groups that did not. Mobilisation initiated within 14-days of SCI was also associated with statistically significant functional gains: (Basso, Beattie and Bresnahan locomotor rating score (BBB) = 2.13(0-21), CI 1.43, 2.84, Ladder Rung Walking Task = - 12.38(0-100), CI 20.01, - 4.76). Meta-analysis identified the greatest functional gains when mobilisation was initiated within 3 days of SCI (BBB = 3.00, CI 2.31-3.69, p < 0.001), or when delivered at low intensity (BBB = 2.88, CI 2.03-3.70, p < 0.001). Confidence in the findings from this review was low to moderate due to the risk of bias and mixed methodological quality. CONCLUSION: Mobilisation instigated within 14-days of injury, may be an effective way of improving functional outcomes in animal models following SCI, with delays potentially detrimental to recovery. Outcomes from this study support further research in this field to guide future clinical practice.

Testing the feasibility of a co-designed intervention, comprising self-managed, home-based, exercise training with embedded behavioural support and compression therapy for people with venous leg ulcers receiving treatment at home (FISCU-II).

BACKGROUND: Venous leg ulcers (VLUs) heal slowly, are painful for patients and are costly for healthcare systems; they also affect patients' quality of life. Previous work suggests that supervised exercise training used in combination with compression therapy may offer clinical benefits. However, a large population of people with VLUs are unable to access such an intervention due to frailty and age. OBJECTIVES: To assess the feasibility of 'FISCU Home' (a co-designed, 12-week home-based self-managed lifestyle programme based on exercise and behaviour support) as an adjunct therapy to compression in people with VLUs. METHODS: Forty people with VLUs, receiving treatment at home, were recruited from community nursing and tissue viability teams, and via a newspaper advertisement. Participants were randomized 1 : 1 either to exercise with behaviour support (three times per week) plus compression therapy or compression only. The feasibility of the programme was assessed using progression criteria that included exercise attendance rate, loss to follow-up, patient preference(s) and adverse events (AEs). Baseline assessments were repeated at 12 weeks and 6 months. Secondary outcomes (i.e. ulcer recurrence, healing rate and healing time) were also documented at these intervals. Intervention and healthcare utilization costs were calculated. RESULTS: The study recruitment rate was 65%, while 75% of the exercise group participants attended all scheduled exercise sessions. All participants completed compression therapy. No serious AEs or exercise-related AEs were reported. Median (interquartile range) ulcer healing time was shorter in the exercise group [29 (7-108) vs. 42 (6-116) weeks]. CONCLUSIONS: The feasibility and acceptability of both a home- and exercise-based lifestyle intervention in conjunction with compression therapy and the study procedures are supported.

Evaluation of a COVID-19 fundamental nursing care guideline versus usual care: The COVID-NURSE cluster randomized controlled trial.

AIM: To evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID-19 on patient experience, care quality, functional ability, treatment outcomes, nurses' moral distress, patient health-related quality of life and cost-effectiveness. DESIGN: Parallel two-arm, cluster-level randomized controlled trial. METHODS: Between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient-reported co-primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention-to-treat analyses. RESULTS: We randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570-572 (98.1%-98.5%) patient participants in 14 clusters. We found no evidence of between-group differences on any patient, nurse or economic outcomes. We found between-group differences over time, in favour of the intervention, for three of our five co-primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the 'other' ethnicity subgroup. CONCLUSION: We did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non-white British patients' experience of care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: We cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required. IMPACT: Fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non-white British patients' experience of care. REPORTING METHOD: CONSORT and CONSERVE. PATIENT OR PUBLIC CONTRIBUTION: Patients with experience of hospitalization with COVID-19 were involved in guideline development and writing, trial management and interpretation of findings.

The facilitators and barriers to improving functional activity and wellbeing in people with dementia: a qualitative study from the process evaluation of Promoting Activity, Independence and Stability in Early Dementia (PrAISED).

BACKGROUND: The PRomoting Activity, Independence and Stability in Early Dementia (PrAISED) study delivered an exercise and functional activity programme to participants living with dementia. A Randomised Controlled Trial showed no measurable benefits in activities of daily living, physical activity or quality of life. OBJECTIVE: To explore participants' responses to PrAISED and explain why an intervention that might be expected to have produced measurable health gains did not do so. METHODS: A process evaluation using qualitative methods, comprising interviews and researcher notes. SETTING: Data were collected in participants' homes or remotely by telephone or videoconferencing. SAMPLE: A total of 88 interviews were conducted with 44 participants living with dementia (n = 32 intervention group; n = 12 control group) and 39 caregivers. A total of 69 interviews were conducted with 26 therapists. RESULTS: Participants valued the intervention as proactively addressing health issues that were of concern to them, and as a source of social contact, interaction, information and advice. Facilitators to achieving positive outcomes included perceiving progress towards desired goals, positive expectations, therapists' skills and rapport with participants, and caregiver support. Barriers included: cognitive impairment, which prevented independent engagement and carry-over between sessions; chronic physical health problems and intercurrent acute illness and injury; 'tapering' (progressively infrequent supervision intended to help develop habits and independent activity); and the COVID-19 pandemic. CONCLUSIONS: Self-directed interventions may not be appropriate in the context of dementia, even in the mild stages of the condition. Dementia-specific factors affected outcomes including caregiver support, rapport with therapists, availability of supervision, motivational factors and the limitations of remote delivery. The effects of cognitive impairment, multimorbidity and frailty overwhelmed any positive impact of the intervention. Maintenance of functional ability is valued, but in the face of inevitable progression of disease, other less tangible outcomes become important, challenging how we frame 'health gain' and trial outcomes.

Recognising and responding to acute deterioration in care home residents: a scoping review.

BACKGROUND: Acute deterioration describes a rapid change in physical and/or mental health resulting from an acute illness - e.g., heart attack or infection. Older people in care homes are some of the frailest and vulnerable in society. They have complex health needs, experience multiple long-term conditions (MLTC) and have weakened immune systems due to the ageing process. They are more susceptible to acute deterioration and delayed recognition and response, is linked to poorer health outcomes, adverse events and death. Over the past five years, the need to manage acute deterioration in care homes and prevent hospital admissions has led to development and implementation of improvement projects, including the use of hospital derived practices and tools to identify and manage this condition. This is potentially problematic as care homes are different from hospitals-options to escalate care vary throughout the UK. Further, hospital tools have not been validated for use in care homes and have shown to be less sensitive in older adults living with frailty. OBJECTIVES: To collate the available evidence on how care home workers recognise and respond to acute deterioration in residents using published primary research, non-indexed and grey literature, policies, guidelines and protocols. METHODS: A systematic scoping review was conducted following Joanna Briggs Institute (JBI) scoping review methodology. Searches were conducted using: CINAHL (EBSCOhost), EMCARE (OVID), MEDLINE (OVID) and HMIC (OVID). Snowball searches of included studies' reference lists were conducted. Studies that featured care homes with or without nursing and provided 24/7 care to residents were included. RESULTS: Three hundred and ninety-nine studies were identified. After reviewing all studies against inclusion criteria, n = 11 were included in the review. All studies used qualitative methods and were conducted in Australia, UK, South Korea, USA and Singapore. Four themes were generated from the review: identifying residents with acute deterioration; managing acute deterioration, care home policies and procedures, and factors affecting recognition and response to acute deterioration. FINDINGS: Recognition and response to acute deterioration in residents is determined by multiple factors and is context sensitive. There are several interrelated factors within and external to the care home that contribute to how acute deterioration is recognised and managed. CONCLUSIONS AND IMPLICATIONS: The available literature on how care home workers recognise and respond to acute deterioration is limited and often subtends other areas of interest. Recognising and responding to acute deterioration in care home residents is reliant on a complex and open system encompassing multiple interrelated components. The phenomenon of acute deterioration remains underexplored and further research is required to examine contextual factors that accompany identification and management of this condition in care home residents.

Pre- and post-operative voice therapy (PaPOV): Development of an intervention for patients with benign vocal fold lesions.

BACKGROUND: Pre- and post-operative voice therapy may improve voice and quality-of-life outcomes for patients undergoing phonosurgery to remove benign vocal fold lesions (BVFLs). However, what constitutes voice therapy in this population is poorly described, resulting in a poor evidence base, lack of clinical guidelines and unwarranted variation in management. In order to develop the evidence base, a robust, iterative process of intervention development work should precede feasibility testing and effectiveness studies. METHODS & PROCEDURES: Guidance for developing complex interventions, drawing on evidence, theory and modelling, was used to inform the development of a pre- and post-operative voice therapy intervention entitled 'PaPOV'. Data from four sources of evidence were synthesized using a published triangulation protocol. Data from a systematic review, national survey of current practice, expert interview study, and patient and public involvement conversations were used to populate a triangulation matrix, outlining components of a PaPOV. Data were coded to reflect areas of agreement, dissonance and silence with each component of the intervention. Based on this evidence, an assessment of convergence for each intervention component could be made. OUTCOMES & RESULTS: In total, 61 components of the PaPOV intervention were explored. Of these, 27 were categorized as having stability of consensus according to a priori criteria. A total of 34 failed to meet the criteria. This was more frequently due to silence (27) rather than dissonance (seven) in the data. By evidencing areas of agreement and stability of consensus across data sources, the validity of individual findings has been enhanced. Furthermore, the study has exposed specific areas of the intervention that lack consensus and require exploration through further intervention development studies. CONCLUSIONS & IMPLICATIONS: This systematic triangulation process has contributed to the development of a PaPOV intervention for patients with BVFLs. Exploration of specific components relating to the intervention will allow outstanding questions to be answered in preparation for feasibility testing. WHAT THIS PAPER ADDS: What is already known on the subject BVFLs cause dysphonia by preventing vocal fold closure, impacting on vibratory characteristics and increasing compensatory muscle tension. Management for these patients is variable with them being offered phonosurgery, voice therapy, pharmacological management or a combined approach. Pre- and post-operative voice therapy may improve both voice and quality-of-life outcomes. This patient group has unique complexities when considering voice therapy, including surgical preparation, wound healing and epithelial mobilization. What this paper adds to existing knowledge This study uses a robust triangulation process to synthesize current evidence and patient experiences in order to inform the development of a PaPOV. It outlines some of the key components and considerations when delivering pre- and post-operative voice therapy to adults with BVFLs. Furthermore, it serves as a methodological example for intervention development in complex interventions, highlighting key guidance and recommended processes for developing and evaluating complex interventions. What are the potential or actual clinical implications of this work? The 61 components discussed as potential 'ingredients' for a PaPOV enable clinicians to reflect on key considerations when planning and delivering voice therapy to adults with BVFLs. This study highlights the pitfalls both clinically and in research of failing to describe interventions adequately and the benefits of using accurate, specific and agreed terminology in clinical practice, such as that outlined in the Rehabilitation Treatment Specification System (TRSS).

The co-design of an exercise-based, lifestyle intervention for people with venous leg ulcers; a self-care, expert-supported strategy for a chronic condition.

Exercise is recommended as an adjunct treatment, alongside compression therapy to increase venous leg ulcer (VLU) wound healing times, however, there are no published programmes available that support patients to exercise at home on their own. To develop an exercise-based lifestyle intervention that is feasible and acceptable to people with VLUs, a participatory approach was utilised. Clinicians, researchers, and people living with VLUs collaborated in the design of "FISCU Home". Two focus groups and nine interviews were conducted with people living with a VLU. Tissue viability nurses provided clinical expertise. Data was analysed through thematic analysis. Ten key themes were identified and incorporated into FISCU Home: (I) a condition-specific flexible programme, (II) personal assessment and tailored exercises, (III) tapered individualised support, (IV) short lower-intensity sessions, (V) chair-based options, (VI) falls prevention, (VII) accessible resources, (VIII) functional, compact, self-managed exercises, (IX) a behaviour change strategy, and (X) education. FISCU Home has integrated patients' needs and preferences with evidence-based principles and theory to create an exercise-based lifestyle intervention for people with VLUs. FISCU Home could provide a mainstream adjunct therapy in wound care and support the movement towards self-management.

Perceptions of Post-Stroke Fatigue among Health Care Practitioners: A Qualitative Interview 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.

'It is designed for everybody to find their own level and to improve themselves'; views of older people and instructors of the Falls Management Exercise (FaME) programme.

BACKGROUND: Older adults are at increased risk of falls due to ageing, decreased muscle strength and impaired balance. Clinical trials have demonstrated the efficacy and effectiveness of the Falls Management Exercise (FaME) programme in improving functioning and preventing falls. However, programme completion is often low, impacting the potential benefits of FaME. OBJECTIVE: To explore the barriers and facilitators for participation and completion of the FaME programme from an instructor and participant perspective. METHODS: Semi-structured interviews were conducted with 20 FaME users and seven Postural Stability Instructors from the East Midlands region of England, UK. Interviews were conducted using a topic guide and explored their views of the programme, intended benefits, reasons for participating, instructor's approach and venue facilities. Data were transcribed verbatim and analysed using thematic analysis. Written informed consent was obtained from all participants and instructors. RESULTS: Common themes identified by participants and instructors for adherence related to perceived health benefits, psychological well-being, intervention characteristics, cost, instructors' qualities, opportunity to socialise, venue accessibility and facilities. Further factors such as maintaining independence, discipline, relationship with peers and caring responsibilities influenced participants' engagement with the programme. Instructor factors such as progression were also reported as important predictors. CONCLUSIONS: Instructor and participant factors influence uptake, attendance and adherence of FaME. The findings from this study can inform the development and improvement of additional falls-prevention programmes. It can also guide marketing strategies to promote uptake of exercise-based falls-prevention programmes among older adults.

A realist evaluation of a multifactorial falls prevention programme in care homes.

BACKGROUND: falls in care homes are common, costly and hard to prevent.Multifactorial falls programmes demonstrate clinical and cost-effectiveness, but the heterogeneity of the care home sector is a barrier to their implementation. A fuller appreciation of the relationship between care home context and falls programme delivery will guide development and support implementation. METHODS: this is a multi-method process evaluation informed by a realist approach.Data include fidelity observations, stakeholder interviews, focus groups, documentary review and falls-rate data. Thematic analysis of qualitative data and descriptive statistics are synthesised to generate care home case studies. RESULTS: data were collected in six care homes where a falls programme was trialled. Forty-four interviews and 11 focus groups complemented observations and document review.The impact of the programme varied. Five factors were identified: (i) prior practice and (ii) training may inhibit new ways of working; (iii) some staff may be reluctant to take responsibility for falls; (iv) some may feel that residents living with dementia cannot be prevented from falling; and, (v) changes to management may disturb local innovation.In some care homes, training and improved awareness generated a reduction in falls without formal assessments being carried out. CONCLUSIONS: different aspects of the falls programme sparked different mechanisms in different settings, with differing impact upon falls.The evaluation has shown that elements of a multifactorial falls programme can work independently of each other and that it is the local context (and local challenges faced), which should shape how a falls programme is implemented.

World guidelines for falls prevention and management for older adults: a global initiative.

BACKGROUND: falls and fall-related injuries are common in older adults, have negative effects on functional independence and quality of life and are associated with increased morbidity, mortality and health related costs. Current guidelines are inconsistent, with no up-to-date, globally applicable ones present. OBJECTIVES: to create a set of evidence- and expert consensus-based falls prevention and management recommendations applicable to older adults for use by healthcare and other professionals that consider: (i) a person-centred approach that includes the perspectives of older adults with lived experience, caregivers and other stakeholders; (ii) gaps in previous guidelines; (iii) recent developments in e-health and (iv) implementation across locations with limited access to resources such as low- and middle-income countries. METHODS: a steering committee and a worldwide multidisciplinary group of experts and stakeholders, including older adults, were assembled. Geriatrics and gerontological societies were represented. Using a modified Delphi process, recommendations from 11 topic-specific working groups (WGs), 10 ad-hoc WGs and a WG dealing with the perspectives of older adults were reviewed and refined. The final recommendations were determined by voting. RECOMMENDATIONS: all older adults should be advised on falls prevention and physical activity. Opportunistic case finding for falls risk is recommended for community-dwelling older adults. Those considered at high risk should be offered a comprehensive multifactorial falls risk assessment with a view to co-design and implement personalised multidomain interventions. Other recommendations cover details of assessment and intervention components and combinations, and recommendations for specific settings and populations. CONCLUSIONS: the core set of recommendations provided will require flexible implementation strategies that consider both local context and resources.

A non-randomised feasibility study of the Rehabilitation Potential Assessment Tool (RePAT) in frail older people in the acute healthcare setting.

BACKGROUND: Rehabilitation potential involves predicting who will benefit from rehabilitation. Decisions about rehabilitation potential must take into account personal, clinical and contextual factors, a process which is complicated in the presence of acute ill-health and frailty. This study aimed to evaluate the feasibility and acceptability of the Rehabilitation Potential Assessment Tool (RePAT) - a 15 item holistic, person-centred assessment tool and training package - in the acute hospital setting. METHODS: A non-randomised feasibility study with nested semi-structured interviews explored whether RePAT was feasible and acceptable. Feasibility was tested by recruiting physiotherapy and occupational therapy participants delivering the RePAT intervention to patients alongside usual clinical care. Acceptability was tested by conducting semi-structured interviews with staff, patient and carer participants. Staff and patient characteristics were analysed using descriptive statistics. Interview data were analysed thematically. Fidelity of completed RePAT items was assessed against a priori criteria on how closely they matched tool guidance by two researchers. Mean values of the two scores were calculated. RePAT content was analysed and supported with verbatim quotes. RESULTS: Six staff participants were recruited and trained. They assessed 26 patient participants using RePAT. Mean (SD) patient age was 86.16 (±6.39) years. 32% were vulnerable or mildly frail, 42% moderately frail and 26% severely or very severely frail using the Clinical Frailty Scale. Mean (SD) time to complete RePAT was 32.7 (±9.6) minutes. RePAT fidelity was good where 13 out of 15 items achieved a priori fidelity. RePAT was acceptable and tolerated by staff and patients. Staff participants reported RePAT enabled them to consider rehabilitation decisions in a more structured and consistent way. Patients and carer participants, although unable to comment directly on RePAT, reported being satisfied with their rehabilitation assessments which were found to embrace a person-centred approach. CONCLUSIONS: RePAT was found to be acceptable and feasible by staff, carers and patients. It allowed clinicians to make explicit their reasoning behind rehabilitation assessments and encouraged them to become more cognisant of factors which affected their clinical decision-making. TRIAL REGISTRATION: ID ISRCTN31938453 . Registered 05/10/2021.

Clinical and cost-effectiveness of a personalised health promotion intervention enabling independence in older people with mild frailty ('HomeHealth') compared to treatment as usual: study protocol for a randomised controlled trial.

BACKGROUND: Frailty is clinically associated with multiple adverse outcomes, including reduced quality of life and functioning, falls, hospitalisations, moves to long-term care and mortality. Health services commonly focus on the frailest, with highest levels of need. However, evidence suggests that frailty is likely to be more reversible in people who are less frail. Evidence is emerging on what interventions may help prevent or reduce frailty, such as resistance exercises and multi-component interventions, but few interventions are based on behaviour change theory. There is little evidence of cost-effectiveness. Previously, we co-designed a new behaviour change health promotion intervention ("HomeHealth") to support people with mild frailty. HomeHealth is delivered by trained voluntary sector support workers over six months who support older people to work on self-identified goals to maintain their independence, such as strength and balance exercises, nutrition, mood and enhancing social engagement. The service was well received in our feasibility randomised controlled trial and showed promising effects upon outcomes. AIM: To test the clinical and cost-effectiveness of the HomeHealth intervention on maintaining independence in older people with mild frailty in comparison to treatment as usual (TAU). METHODS: Single-blind individually randomised controlled trial comparing the HomeHealth intervention to TAU. We will recruit 386 participants from general practices and the community across three English regions. Participants are included if they are community-dwelling, aged 65 + , with mild frailty according to the Clinical Frailty Scale. Participants will be randomised 1:1 to receive HomeHealth or TAU for 6 months. The primary outcome is independence in activities of daily living (modified Barthel Index) at 12 months. Secondary outcomes include instrumental activities of daily living, quality of life, frailty, wellbeing, psychological distress, loneliness, cognition, capability, falls, carer burden, service use, costs and mortality. Outcomes will be analysed using linear mixed models, controlling for baseline Barthel score and site. A health economic analysis and embedded mixed-methods process evaluation will be conducted. DISCUSSION: This trial will provide definitive evidence on the effectiveness and cost-effectiveness of a home-based, individualised intervention to maintain independence in older people with mild frailty in comparison to TAU, that could be implemented at scale if effective. TRIAL REGISTRATION: ISRCTN, ISRCTN54268283 . Registered 06/04/2020.

Impact of COVID-19 and other infectious conditions requiring isolation on the provision of and adaptations to fundamental nursing care in hospital in terms of overall patient experience, care quality, functional ability, and treatment outcomes: systematic review.

AIM: This systematic review identifies, appraises and synthesizes the evidence on the provision of fundamental nursing care to hospitalized patients with a highly infectious virus and the effectiveness of adaptations to overcome barriers to care. DESIGN: Systematic review. DATA SOURCES: In July 2020, we searched Medline, PsycINFO (OvidSP), CINAHL (EBSCOhost), BNI (ProQuest), WHO COVID-19 Database (https://search.bvsalud.org/) MedRxiv (https://www.medrxiv.org/), bioRxiv (https://www.biorxiv.org/) and also Google Scholar, TRIP database and NICE Evidence, forwards citation searching and reference checking of included papers, from 2016 onwards. REVIEW METHODS: We included quantitative and qualitative research reporting (i) the views, perceptions and experiences of patients who have received fundamental nursing care whilst in hospital with COVID-19, MERS, SARS, H1N1 or EVD or (ii) the views, perceptions and experiences of professional nurses and non-professionally registered care workers who have provided that care. We included review articles, commentaries, protocols and guidance documents. One reviewer performed data extraction and quality appraisal and was checked by another person. RESULTS: Of 3086 references, we included 64 articles; 19 empirical research and 45 review articles, commentaries, protocols and guidance documents spanning five pandemics. Four main themes (and 11 sub-themes) were identified. Barriers to delivering fundamental care were wearing personal protective equipment, adequate staffing, infection control procedures and emotional challenges of care. These barriers were addressed by multiple adaptations to communication, organization of care, staff support and leadership. CONCLUSION: To prepare for continuation of the COVID-19 pandemic and future pandemics, evaluative studies of adaptations to fundamental healthcare delivery must be prioritized to enable evidence-based care to be provided in future. IMPACT: Our review identifies the barriers nurses experience in providing fundamental care during a pandemic, highlights potential adaptations that address barriers and ensure positive healthcare experiences and draws attention to the need for evaluative research on fundamental care practices during pandemics.

Learning from a successful process evaluation in care homes.

INTRODUCTION: process evaluations (PE) are increasingly used in parallel with randomised controlled trials (RCT) to inform the implementation of complex health interventions. This paper explores the learning accrued from conducting a PE within the Falls in Care Homes Study (FinCH), a large UK RCT. METHODS: in the FinCH study, six purposively sampled care homes provided data for the PE, which followed a realist approach. In this study researchers kept written diaries of their experiences in completing the interviews, focus groups and observations. We have reflected on these and present the main themes for discussion. FINDINGS: care home staff were enthusiastic to participate in the PE but researchers found it difficult to collect data due to staff not having time to take part, environmental factors such as no space for focus groups and low levels of research understanding. Researchers found that the expectations of the PE protocol were often unrealistic due to these limitations. Flexible and pragmatic approaches such as interviews in place of focus groups enabled data collection but required a reduced sample size and length of data collection to be accepted by researchers. CONCLUSION: to enable care home staff to participate in successful PEs, researchers should build flexibility into research schedules, spend time building trust, collaborate with all levels of care home staff prior to data collection, increase research capacity in care home staff and co-design research projects.

New horizons in falls prevention and management for older adults: a global initiative.

BACKGROUND: falls and fall-related injuries are common in older adults, have negative effects both on quality of life and functional independence and are associated with increased morbidity, mortality and health care costs. Current clinical approaches and advice from falls guidelines vary substantially between countries and settings, warranting a standardised approach. At the first World Congress on Falls and Postural Instability in Kuala Lumpur, Malaysia, in December 2019, a worldwide task force of experts in falls in older adults, committed to achieving a global consensus on updating clinical practice guidelines for falls prevention and management by incorporating current and emerging evidence in falls research. Moreover, the importance of taking a person-centred approach and including perspectives from patients, caregivers and other stakeholders was recognised as important components of this endeavour. Finally, the need to specifically include recent developments in e-health was acknowledged, as well as the importance of addressing differences between settings and including developing countries. METHODS: a steering committee was assembled and 10 working Groups were created to provide preliminary evidence-based recommendations. A cross-cutting theme on patient's perspective was also created. In addition, a worldwide multidisciplinary group of experts and stakeholders, to review the proposed recommendations and to participate in a Delphi process to achieve consensus for the final recommendations, was brought together. CONCLUSION: in this New Horizons article, the global challenges in falls prevention are depicted, the goals of the worldwide task force are summarised and the conceptual framework for development of a global falls prevention and management guideline is presented.

Rehabilitation potential in older people living with frailty: a systematic mapping review.

BACKGROUND: Following periods of acute ill-health and injury, older people are frequently assessed and provided with rehabilitation services. Healthcare practitioners are required to make nuanced decisions about which patients are likely to benefit from and respond to rehabilitation. The clinical currency in which these decisions are transacted is through the term "rehabilitation potential". The aim of this study was to explore information about rehabilitation potential in older people to inform the development of an evidence-based assessment tool. METHODS: A systematic mapping review was completed to describe the extent of research and the concepts underpinning rehabilitation potential. We searched Medline, CINHAL, EMBASE, AMED, PsycINFO, PEDro, Cochrane Library, Web of Science, ProQuest, Trip and EThOS from inception to December 2020. We included studies which focused on rehabilitation potential and/or assessing for rehabilitation interventions for older people with comorbidities in the hospital and community setting. Reviewer pairs independently screened articles and extracted data against the inclusion criteria. A descriptive narrative approach to analysis was taken. RESULTS: 13,484 papers were identified and 49 included in the review. Rehabilitation potential was found to encompass two different but interrelated concepts of prognostication and outcome measurement. 1. Rehabilitation potential for prognostication involved the prediction of what could be achieved in programmes of rehabilitation. 2. Rehabilitation potential as an outcome measure retrospectively considered what had been achieved as a result of rehabilitation interventions. Assessments of rehabilitation potential included key domains which were largely assessed by members of the multi-disciplinary team at single time points. Limited evidence was identified which specifically considered rehabilitation potential amongst older people living with frailty. CONCLUSIONS: Current approaches to rehabilitation potential provide a snapshot of an individual's abilities and conditions which fail to capture the dynamic nature and fluctuations associated with frailty and rehabilitation. New approaches to measures and abilities over time are required which allow for the prognostication of outcomes and potential benefits of rehabilitation interventions for older people living with frailty.

Physical activity engagement strategies in people with mild cognitive impairment or dementia - a focus group study.

Objective: This focus group study aimed to explore how to motivate people with mild cognitive impairment (MCI) or dementia and their carers to engage in exercise and physical activity.Methods: Four focus groups were conducted with six people with MCI or dementia, three carers and four clinicians (nurse, occupational therapist, physiotherapists). A thematic analysis of the data was undertaken.Results: Five main themes were identified: 'memory problems', 'self-motivation', 'external motivation', 'design of activities' and 'barriers'. Participants viewed exercise positively but emphasised that it needed to fit into their daily routine. Goal-setting was seen as helpful by some participants but others saw this as a source of potential failure. Enjoyment was seen as key to engagement.Conclusion: Exercise and physical activity interventions need an individualised approach to engage people with MCI or dementia, with a positive emphasis on enjoyment. Goal-setting should be used with caution in this group of people.

Promoting activity, Independence and stability in early dementia (PrAISED): a, multisite, randomised controlled, feasibility trial.

BACKGROUND: We tested the feasibility of delivering and evaluating a complex therapy intervention which aimed to promote activity and independence for people with early dementia (PrAISED). Feasibility questions were on: recruitment, randomisation, intervention delivery, adherence and withdrawals, level of supervision required, adverse events, data collection and sample size assumptions. METHODS: We conducted a three-arm, multi-site, single-blind, randomised controlled feasibility trial. Eligibility criteria were aged 65 years or older, diagnosed mild dementia or mild cognitive impairment, able to walk without human help, and communicate in English, no co-morbidities that prevented participation in cognitive assessment and capacity to give consent. Participants were recruited from Memory Assessment Service clinics and the 'Join Dementia Research' register. Patient participants were randomised 1:1:1 to a high intensity supervision PrAISED intervention, moderate intensity supervision PrAISED intervention or brief falls prevention assessment and advice (control). The PrAISED intervention aimed for participants to complete three hours of PrAISED exercises a week for 12 months. It included individualised activity and exercise plans and supervised exercises with regular re-assessment and progression, and was delivered by occupational therapists, physiotherapists and rehabilitation support workers. Primary efficacy outcome was the Disability Assessment for Dementia (DAD), measured after 12 months. Secondary outcomes included physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain. Falls and activity were ascertained by monthly diary. RESULTS: Between September 2016 and March 2017 we recruited 60 patient participants and 54 carer participants from two sites. Forty-nine patient participants completed a follow-up interview. Feasibility outcomes were mostly satisfactory, including recruitment and retention, intervention delivery and data completeness for most scales used. We could not maintain blinding of researchers at follow-up and experienced difficulties collecting data using some questionnaires and devices. Participants only completed a mean 77 (moderate supervision) and 71 (high supervision) minutes per week of PrAISED exercises over 12 months. We recorded 19 adverse events, none serious and related to the intervention. CONCLUSION: We conclude that with some adjustments to the trial protocol, it is feasible to deliver the PrAISED intervention and conduct a trial. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02874300 (first posted 22nd August 2016), ISRCTN: 10550694 (date assigned 31st August 2016).