Vicky Booth

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.

To implement a job retention vocational rehabilitation (VR) intervention (MSVR) for people with multiple sclerosis (MS) and their employers in the UK National Health Service (NHS). Multicentre, single-arm feasibility study with post-intervention interviews. MSVR was delivered by an occupational therapist (OT). Feasibility was assessed by recruitment rates, compliance, and practicality of delivery. Acceptability was assessed with post-intervention interviews. A survey assessed change in eight vocational outcomes (e.g., vocational goals, work instability) immediately post-intervention and at 3-month follow-up. Recruitment and training an OT was challenging. Twenty participants with MS, three employers, and three healthcare professionals were recruited. All participants but one completed the intervention. Factors affecting intervention adherence included annual leave and family responsibilities.MSVR was associated with improved vocational goal attainment post-intervention (t(18) = 7.41, p = <0.001) and at follow-up (t(17) = 6.01, p = <0.001). There was no change to the remaining outcomes. Interviews identified six themes: intervention impact, accessibility of support, the OT's role, readiness for support, workplace supportiveness, and barriers to NHS delivery. Challenges with recruitment, identifying newly diagnosed MS participants, and understanding the OT's training needs to deliver the intervention were identified. The intervention demonstrated acceptability, but participants wanted it to continue for longer to address further needs.

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.

Approximately 20% of acquired brain injury (ABI) survivors experience reduced psychological wellbeing (PWB). Neuropsychological rehabilitation (NPR) is one approach supporting people with ABI to participate meaningfully in activities despite challenges. Although literature supports NPR effectiveness, little is known about change mechanisms. This systematic realist review identifies what NPR programmes have been designed, delivered, and evaluated for people with ABI to improve PWB and/or quality of life (QOL), as well as providing a context-relevant understanding of what NPR includes and how NPR might lead to positive outcomes. A rapid realist review was conducted in three phases: (1) structured retrieval and evidence extraction; (2) stakeholder consultation; (3) analysis and synthesis. Searches were completed, and findings from 35 publications and one stakeholder consultation were synthesized into a refined logic model. Six context-mechanism-outcome chains (CMOCs) were identified. Participants' relationships to internal experiences, and feelings of self-worth, mastery, and connection appeared to be mechanisms that led to improved PWB and QOL. Adaptation and individualized programmes were also key mechanisms to explain successful NPR. Embedding CMOCs into NPR could improve PWB and/or QOL for people with ABI. The logic model will inform ongoing development of a new online, group-based, NPR programme.

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. 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. A process evaluation using qualitative methods, comprising interviews and researcher notes. Data were collected in participants’ homes or remotely by telephone or videoconferencing. 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. 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. 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.

Purpose: To investigate the longitudinal associations between pain and depressive symptoms in adults. Methods: Prospective cohort study on data from 28,515 community-dwelling adults ≥ 50 years, free from depression at baseline (Wave 5), with follow-up in Wave 6 of the Survey of Health, Ageing and Retirement in Europe (SHARE). Significant depressive symptoms were defined by a EURO-D score ≥ 4. The longitudinal association between baseline pain intensity and significant depressive symptoms at follow-up was analysed using logistic regression models; odds ratios (ORs) and confidence intervals (CI) were calculated, adjusting for socio-demographic and clinical factors, physical inactivity, loneliness, mobility and functional impairments. Results: Mean age was 65.4 years (standard deviation 9.0, range 50–99); 14,360 (50.4%) participants were women. Mean follow-up was 23.4 (standard deviation 3.4) months. At baseline, 2803 (9.8%) participants reported mild pain, 5253 (18.4%) moderate pain and 1431 (5.0%) severe pain. At follow-up, 3868 (13.6%) participants—1451 (10.3%) men and 2417 (16.8%) women—reported significant depressive symptoms. After adjustment, mild, moderate and severe baseline pain, versus no pain, were associated with an increased likelihood of significant depressive symptoms at follow-up: ORs (95% CI) were 1.20 (1.06–1.35), 1.32 (1.20–1.46) and 1.39 (1.19–1.63), respectively. These associations were more pronounced in men compared to women, and consistent in participants aged 50–64 years, those without mobility or functional impairment, and those without loneliness at baseline. Conclusion: Higher baseline pain intensity was longitudinally associated with a greater risk of significant depressive symptoms at 2-year follow-up, in community-dwelling adults without baseline depression.

Background: Realist reviews are a type of systematic theory‐driven approach for making sense and evaluating the literature with the intention to identify plausible theories or models. This review will determine what literature and theoretical knowledge is available on “personalisation” in the context of exercise for people living with dementia (PwD). The aim of the review is to develop an initial programme theory that can be used to inform the development and testing of resources to support exercise interventions for PwD.Method: Electronic databases and gg terms: personalisation, tailoring, adaptations, person‐centred, etc. Inclusion criteria were:• PwD (any type, severity, or location)• Exercise intervention (all forms)• Explicit discussion of theoretical concepts or rationale to PersonalisationArticles were not excluded based on study design. A preliminary search to scope the evidence, refine search terms and criteria was undertaken before the start of this review.Data were collected from the included articles and managed through data analysis software that accommodates both qualitative and quantitative data (Excel). The review was registered on PROSPERO and followed RAMESES guidance and publication standards.Result: Of the 2036 articles initially found, data extraction was completed from 64, following sorting for relevance and rigour (Figure 1). An initial programme theory involving 11 context‐mechanism‐outcome configurations (CMOc) is presented (Table 1) at different socio‐ecological levels of interaction needed to underpin a personalised exercise programme for PwD.Consideration of the individual’s identity, preference, preserved/embodied abilities, vulnerabilities, motivations (behaviour change), and their care‐giver should be acknowledged at an inter/intra‐personal level. Staff implementing the exercise programmes should have a person‐centered care approach, acknowledging concepts of personhood and using shared decision‐making. Finally, the cultural norms and expectations of the society within which the exercise programme is being conducted, and the PwD is situated within, should be considered to promote social connections rather than stigmatisation.Conclusion: The initial programme theory explains personalisation and illustrates a novel foundation upon which to develop and refine a programme of exercise adapted specifically for PwD. Results from this review will inform data collection in the subsequent realist evaluation (e.g., interview questions).

Background: Management of benign vocal fold lesions (BVFLs) is variable with some receiving surgery, voice therapy or a combination of these approaches. Some evidence suggests that the best outcomes may be achieved when patients are offered pre and post-operative voice therapy in addition to phonosurgery, but what constitutes pre and post-operative voice therapy is poorly described. The pre and post-operative voice therapy (PaPOV) intervention has been developed and described according to the TiDIER checklist and Rehabilitation Treatment Specification System for voice. The PaPOV intervention is delivered by specialist speech and language therapists trained in the intervention and comprises 7 essential and 4 additional components, delivered in voice therapy sessions with patients who are having surgery on their vocal folds for removal of BVFLs. Study Design: Non-randomised, multicentre feasibility trial with embedded process evaluation Method: 40 patients from two sites who are due to undergo phonosurgery will be recruited to receive the PaPOV intervention. Measures of feasibility, including recruitment, retention, and adherence will be assessed. The feasibility of gathering clinical and cost effectiveness data will be measured pre treatment, then at 3 and 6 months post-operatively. An embedded process evaluation will be undertaken to explain feasibility findings. Discussion: This study will assess the feasibility of delivering a described voice therapy intervention protocol to patients who are undergoing surgery for removal of benign vocal fold lesions (BVFLs). Findings will be used to inform the development and implementation of a subsequent effectiveness trial, should this be feasible. TRIAL REGISTRATION This trial has been prospectively registered on ISRCTN, (date 4^th January 2023), registration number 17438192 and can be viewed here: https://www.isrctn.com/ISRCTN17438192

Older people living with dementia are advised to exercise to remain independent. Although several exercise classes for older people take place across the UK, there is limited information about the geographical distribution of these classes. This study identified the location and explored the population characteristics of the classes in a UK region, to aid improved access to exercise. Using a geographical information system, data were collected on population characteristics, including size and age, socio-economic status, and rurality of the exercise classes in one area of the UK (East Midlands, population 5 million). The relationship between data sets was explored and a visual representation of these patterns was provided. A systematic internet search identified 520 exercise classes, evenly spread across the region and areas of socio-economic deprivation: 471 (90%) were in urban areas; 428 (80%) were in areas where less than 20% of the population was over 65 years of age; and 13 (2%) stated that they were suitable for people with dementia. People living with dementia are less likely than older people without dementia to have access to exercise classes.