Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial.

OBJECTIVE: To determine the effectiveness of an exercise and functional activity therapy intervention in adults with early dementia or mild cognitive impairment compared with usual care. DESIGN: Randomised controlled trial. SETTING: Participants' homes and communities at five sites in the United Kingdom. PARTICIPANTS: 365 adults with early dementia or mild cognitive impairment who were living at home, and family members or carers. INTERVENTION: The intervention, Promoting activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED), was a specially designed, dementia specific, rehabilitation programme focusing on strength, balance, physical activity, and performance of activities of daily living, which was tailored and progressive and addressed risk and the psychological needs of people with dementia. Up to 50 therapy sessions were provided over 12 months. The control group received usual care plus a falls risk assessment. Procedures were adapted during the covid-19 pandemic. MAIN OUTCOME MEASURES: The primary outcome was score on the carer (informant) reported disability assessment for dementia scale 12 months after randomisation. Secondary outcomes were self-reported activities of daily living, physical activity, quality of life, balance, functional mobility, fear of falling, frailty, cognition, mood, carer strain, service use at 12 months, and falls between months 4 and 15. RESULTS: 365 patient participants were randomised, 183 to intervention and 182 to control. The median age of participants was 80 years (range 65-95), median Montreal cognitive assessment score was 20 out of 30 (range 13-26), and 58% (n=210) were men. Intervention participants received a median of 31 therapy sessions (interquartile range 22-40) and reported completing a mean 121 minutes of PrAISED exercise each week. Primary outcome data were available for 149 intervention and 141 control participants. Scores on the disability assessment for dementia scale did not differ between groups: adjusted mean difference -1.3, 95% confidence interval -5.2 to 2.6; Cohen's d effect size -0.06, 95% confidence interval -0.26 to 0.15; P=0.51). Upper 95% confidence intervals excluded small to moderate effects on any of the range of outcome measures. Between months 4 and 15 the intervention group experienced 79 falls and the control group 200 falls (adjusted incidence rate ratio 0.78, 95% confidence interval 0.5 to 1.3; P=0.3). CONCLUSION: The intensive PrAISED programme of exercise and functional activity training did not improve activities of daily living, physical activity, or quality of life; reduce falls; or improve any other secondary health status outcomes, despite good uptake. Future research should consider alternative approaches to maintaining ability and wellbeing in people with dementia. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15320670.

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.

A Qualitative Study on the Experiences of Therapists Delivering the Promoting Activity, Independence and Stability in Early Dementia (PrAISED) Intervention During the COVID-19 Pandemic.

BACKGROUND: The Promoting Activity, Independence and Stability in Early Dementia (PrAISED) intervention is a programme of physical activity and exercise designed to maintain participation in activities of daily living, mobility, and quality of life for people living with dementia. During the COVID-19 pandemic first national lockdown in England, the PrAISED physiotherapists, occupational therapists, and rehabilitation support workers adapted to delivering the intervention remotely via telephone or video conferencing. OBJECTIVE: The aim of this study was to explore therapists' experience of delivering the PrAISED intervention during the COVID-19 pandemic and derive implications for clinical practice. METHODS: Qualitative semi-structured interviews were conducted with 16 therapists using purposive sampling. Thematic analysis was used to analyze the transcripts. RESULTS: Therapists reported a change in the relationship between themselves, the person with dementia and the caregiver, with an increased reliance on the caregiver and a loss of autonomy for the person living with dementia. There was concern that this would increase the burden on the caregiver. The therapists reported using creativity to adapt to different modes of delivery. They felt their sessions were mostly focused on providing social and emotional support, and that assessing, progressing, and tailoring the intervention was difficult. CONCLUSION: It is possible to deliver some elements of a physical intervention using remote delivery, but a dual modal approach including remote and face-to-face delivery would optimize treatment efficacy. Educational support would be required to enable people living with dementia and their caregivers to overcome barriers relating to digital literacy.

Deconditioning in people living with dementia during the COVID-19 pandemic: qualitative study from the Promoting Activity, Independence and Stability in Early Dementia (PrAISED) process evaluation.

BACKGROUND: Restrictions introduced in response to the COVID-19 pandemic led to increased risk of deconditioning in the general population. No empirical evidence of this effect however has been gathered in people living with dementia. This study aims to identify the causes and effects of COVID-19-related deconditioning in people living with dementia. METHODS: This is a longitudinal phenomenological qualitative study. Participants living with dementia, their caregivers and therapists involved in the Promoting Activity, Independence and Stability in Early Dementia (PrAISED) process evaluation during the COVID-19 pandemic were qualitatively interviewed at two time points: the baseline 2 months after the national lockdown was imposed in England (i.e., May 2020), the follow up 2 months after the first set (i.e. July 2020). The data were analysed through deductive thematic analysis. RESULTS: Twenty-four participants living with dementia, 19 caregivers and 15 therapists took part in the study. Two themes were identified: Causes of deconditioning in people living with dementia during the COVID-19 pandemic and effects of deconditioning in people living with dementia during the COVID-19 pandemic. A self-reinforcing pattern was common, whereby lockdown made the person apathetic, demotivated, socially disengaged, and frailer. This reduced activity levels, which in turn reinforced the effects of deconditioning over time. Without external supporters, most participants lacked the motivation / cognitive abilities to keep active. Provided the proper infrastructure and support, some participants could use tele-rehabilitation to combat deconditioning. CONCLUSION: The added risks and effects of deconditioning on people with dementia require considerable efforts from policy makers and clinicians to ensure that they initiate and maintain physical activity in prolonged periods of social distancing. Delivering rehabilitation in the same way as before the pandemic might not be feasible or sustainable and innovative approaches must be found. Digital support for this population has shown promising results but remains a challenge. TRIAL REGISTRATION: The PrAISED trial and process evaluation have received ethical approval number 18/YH/0059 from the Bradford/Leeds Ethics Committee. The ISRCTN Registration Number for PrAISED is  15320670 .

Mixed-Methods Study on Caregiver Strain, Quality of Life, and Perceived Health.

BACKGROUND: Caring for someone with dementia is associated with negative and positive experiences. There is little evidence based on large datasets. OBJECTIVE: To present data around the experience of caring for someone with dementia, to identify support (emotional and practical) needs, and inform future service provision. METHODS: A mixed-methods study embedded in the Promoting Activity, Independence and Stability in Early Dementia (PrAISED) Randomized Controlled Trial. We administered questionnaires on strain, quality of life (QoL), and perceived health to 301 caregivers and assessment of cognitive performance, depression, anxiety, and disability in activities of daily living to 301 participants with dementia. Data were analyzed through descriptive and modelling statistics. A subsample of 20 patient-caregiver dyads were qualitatively interviewed. Data around caregivers' experience of providing care were extrapolated and analyzed through inductive thematic analysis. RESULTS: There were significant negative associations between caregiver strain and QoL (p < 0.01) and between caregiver age and QoL (p < 0.01), and significant positive associations between caregiver strain and disability (p < 0.01), cognitive impairment (p < 0.01), depression (p < 0.05), and anxiety of the person with dementia (p < 0.05). Older caregivers reported a lack of support, reinforced by their reluctance to seek help. All caregivers reported contradictory emotions associated with caring and accumulation of strain over time. CONCLUSION: While there is recognition that it is essential to support caregivers, dedicated intervention programs, and support strategies to respond to the needs of older caregivers are still needed.

Tele-Rehabilitation for People with Dementia during the COVID-19 Pandemic: A Case-Study from England.

Introduction: The Promoting Activity, Independence and Stability in Early Dementia (PrAISED) is delivering an exercise programme for people with dementia. The Lincolnshire partnership National Health Service (NHS) foundation Trust successfully delivered PrAISED through a video-calling platform during the Coronavirus Disease 2019 (COVID-19) pandemic. METHODS: This qualitative case-study aimed to identify participants that video delivery worked for, to highlight its benefits and its challenges. Interviews were conducted between May and August 2020 with five participants with dementia and their caregivers (n = 10), as well as five therapists from the Lincolnshire partnership NHS foundation Trust. The interviews were analysed through thematic analysis. RESULTS: Video delivery worked best when participants had a supporting caregiver and when therapists showed enthusiasm and had an established rapport with the client. Benefits included time efficiency of sessions, enhancing participants' motivation, caregivers' dementia awareness, and therapists' creativity. Limitations included users' poor IT skills and resources. DISCUSSION: The COVID-19 pandemic required innovative ways of delivering rehabilitation. This study supports that people with dementia can use tele-rehabilitation, but success is reliant on having a caregiver and an enthusiastic and known therapist.

Protocol for the process evaluation of the Promoting Activity, Independence and Stability in Early Dementia (PrAISED), following changes required by the COVID-19 pandemic.

INTRODUCTION: The Promoting Activity, Independence and Stability in Early Dementia (PrAISED) randomised controlled trial (RCT) is evaluating a home-based, face-to-face, individually tailored, activity and exercise programme for people living with dementia. Social distancing requirements following the COVID-19 pandemic necessitated rapid changes to intervention delivery. METHODS AND ANALYSIS: A mixed-methods process evaluation will investigate how the changes were implemented and the impact that these have on participants' experience. An implementation study will investigate how the intervention was delivered during the pandemic. A study on the mechanisms of impact and context will investigate how these changes were experienced by the PrAISED participants, their carers and the therapists delivering the intervention. The study will commence in May 2020. ETHICS AND DISSEMINATION: The PrAISED RCT and process evaluation have received ethical approval number 18/YH/0059. The PrAISED process evaluation will enable us to understand how distancing and isolation affected participants, their activity and exercise routines and whether the therapy programme could be continued with remote support. This will be valuable both in explaining trial results and also contribute to understanding and designing new ways of delivering home-based services and rehabilitation interventions for people with dementia and their carers. TRIAL REGISTRATION NUMBER: ISRCTN15320670; Pre-results.

Adding to the knowledge on Patient and Public Involvement: Reflections from an experience of co-research with carers of people with dementia.

BACKGROUND: Patient and Public Involvement (PPI) in research ensures that publicly funded research reflects the priorities of the people who will be affected by its results. Co-research, a branch of PPI, is equal partnership between academic researchers and members of the public, who steer and conduct research together. OBJECTIVES: To propose a model for good practice in co-researching with carers of people with dementia, by reporting and synthesizing the personal reflections of the academic and lay researchers around the methodological issues, benefits, and challenges of co-research. DESIGN: An academic researcher and two lay researchers with lived experience of caring with someone with dementia collaborated in all stages of a qualitative research study, including development of the research protocol and topic guide, data collection, analysis and synthesis, and dissemination of findings. Throughout the study, the academic and lay researchers annotated reflections of their experience in personal diaries. Data from the diaries were synthesized and mapped out in a model for good practice in co-research. RESULTS: Co-research yielded benefits for all those involved and on research outputs. There were practicalities and challenges that required extra resources, in order to make the involvement of lay researchers meaningful and effective. DISCUSSION: The model for good practice illustrates overarching and stage-specific guidelines, which can inform researchers and members of the public wishing to undertake good practice in co-research.

External Validation of the 'PHYT in Dementia', a Theoretical Model Promoting Physical Activity in People with Dementia.

Physical activity is beneficial for people with dementia. We previously developed a theoretical model to explain behaviour change in physical activity in dementia (PHYT-in-dementia). This study aimed to externally validate the model. Validation occurred through the process evaluation of a programme promoting activity in people with dementia (PrAISED 2). Twenty participants with dementia and their carers were interviewed to investigate their experience of the programme. The data were analysed through content analysis. The original constructs of the model were used as initial codes and new codes were generated, if elicited from the data. The constructs were also ranked, based on their frequency in the interviews. All of the original model constructs were validated and two novel constructs created: 'personal history' and 'information/knowledge'. Certain constructs (e.g., support) were more frequently mentioned than others (e.g., personal beliefs). We suggested modifications and integrated them into a revised model. The PHYT-in-dementia recognised that dementia has an impact on motivation to initiate and maintain behaviour change over time. The model advocates that interventions adopt a more holistic approach than traditional behaviour change strategies. The suggested revisions require further validation to accurately predict behaviour change in physical activity in people with dementia.

Protocol for the process evaluation of the promoting activity, independence and stability in early dementia and mild cognitive impairment (PrAISED 2) randomised controlled trial.

INTRODUCTION: We are conducting a randomised controlled trial (Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment - PrAISED 2) to test the effectiveness of an intervention to promote activity and independence amongst people with mild cognitive impairment and early dementia. A process evaluation is needed to determine how the intervention works. This protocol outlines the rationale, aims, objectives and methods of the process evaluation. METHODS: The process evaluation will use a mixed-methods design and comprise two studies: An implementation study, examining the process through which PrAISED 2 is delivered, and a study on the mechanisms of impact and context, focussing on the mediating mechanisms that contribute to study outcomes. Integration of separate analyses of quantitative and qualitative data will provide a holistic view of how the PrAISED 2 intervention works. CONCLUSION: Results from this process evaluation will further the understanding of the factors that can impinge on the success of complex interventions. This will represent invaluable information for researchers undertaking further research around behaviour change among people with cognitive impairment and dementia.

A randomised controlled trial of an exercise intervention promoting activity, independence and stability in older adults with mild cognitive impairment and early dementia (PrAISED) - A Protocol.

BACKGROUND: People with dementia progressively lose cognitive and functional abilities. Interventions promoting exercise and activity may slow decline. We developed a novel intervention to promote activity and independence and prevent falls in people with mild cognitive impairment (MCI) or early dementia. We successfully undertook a feasibility randomised controlled trial (RCT) to refine the intervention and research delivery. We are now delivering a multi-centred RCT to evaluate its clinical and cost-effectiveness. METHODS: We will recruit 368 people with MCI or early dementia (Montreal Cognitive Assessment score 13-25) and a family member or carer from memory assessment clinics, other community health or social care venues or an online register (the National Institute for Health Research Join Dementia Research). Participants will be randomised to an individually tailored activity and exercise programme delivered using motivational theory to promote adherence and continued engagement, with up to 50 supervised sessions over one year, or a brief falls prevention assessment (control). The intervention will be delivered in participants' homes by trained physiotherapists, occupational therapists and therapy assistants. We will measure disabilities in activities of daily living, physical activity, balance, cognition, mood, quality of life, falls, carer strain and healthcare and social care use. We will use a mixed methods approach to conduct a process evaluation to assess staff training and delivery of the intervention, and to identify individual- and context-level mechanisms affecting intervention engagement and activity maintenance. We will undertake a health economic evaluation to determine if the intervention is cost-effective. DISCUSSION: We describe the protocol for a multi-centre RCT that will evaluate the clinical and cost-effectiveness of a therapy programme designed to promote activity and independence amongst people living with dementia. TRIAL REGISTRATION: ISRCTN, ISRCTN15320670. Registered on 4 September 2018.