RCT-based Social Return on Investment (SROI) of a home exercise programme for people with early dementia comparing in-person and blended delivery before and during the COVID-19 pandemic (preprint)

Background: Regular exercise and community engagement may slow the rate of function loss for people with dementia. However, the evidence is uncertain regarding the cost-effectiveness and social return on investment (SROI) of home exercise with community referral for people with dementia. This study aimed to compare the social value generated from the in-person PrAISED programme delivered before March 2020 with a blended PrAISED programme delivered after March 2020. Methods: SROI analysis was conducted alongside a randomised controlled trial (RCT). Of 205 patient participants and their carers who completed cost data, 61 completed an in-person programme before March 2020. Due to COVID-19 pandemic restrictions, 144 patient participants completed a blended programme consisting of a combination of in-person visits, phone calls and video conferencing with multidisciplinary team (MDT) members. SROI analysis compared in-person and blended delivery formats. Five relevant and material outcomes were identified: three outcomes for patient participants (fear of falling, health-related quality of life, and social connection); one outcome for carer participants (carer strain index), and one outcome for the NHS (health service resource use). Data were collected at baseline and a 12-month follow-up. Results: The in-person PrAISED programme generated SROI ratios ranging from 0.58 Great Britain Pound (GBP) to 2.33 GBP for every 1 GBP invested. In-person PrAISED patient participants gained social value from improved health-related quality of life, social connection, and less fear of falling. In-person PrAISED carer participants acquired social value from less carer strain. The NHS gained benefit from less health care service resource use. However, the blended PrAISED programme generated lower SROI ratios ranging from a negative ratio to 0.08 GBP : 1 GBP. Conclusion: Compared with the blended programme, the PrAISED in-person programme generated higher SROI ratios for people with early dementia. During the COVID-19 pandemic and its restrictions, a blended delivery of the programme and the curtailment of community activities resulted in lower SROI ratios during this period. An in-person PrAISED intervention with community referral is likely to provide better value for money than a blended one with limited community referral, despite the greater costs of the former.

Promoting Activity, Independence and Stability in early dementia and mild cognitive impairment (PrAISED): A randomised controlled trial (preprint)

Background: Dementia is associated with frailty leading to increased risks of falls and hospitalisations. Interventions are required to maintain functional ability, strength and balance. Design: Multi-centre parallel group randomised controlled trial, with embedded process evaluation. Procedures were adapted during the COVID-19 pandemic. Participants: People with mild dementia or mild cognitive impairment (MCI), living at home, and a family member or carer. Objectives: To determine the effectiveness of an exercise and functional activity therapy intervention compared to usual care. Intervention: A specially-designed dementia-specific rehabilitation programme focussing on strength, balance, physical activity and performance of ADL, which was tailored, progressive, addressed risk and the psychological and learning needs of people with dementia, providing up to 50 therapy sessions over 12 months. The control group received usual care plus a falls risk assessment. Main outcome measure: The primary outcome was the informant-reported Disability Assessment for Dementia (DAD) 12 months after randomisation. Secondary outcomes were: self-reported ADL, cognition, physical activity, quality of life, frailty, balance, functional mobility, fear of falling, mood, carer strain and service use (at 12 months) and falls (between months 4 and 15). Results: 365 people were randomised, 183 to intervention and 182 to control. Median age of participants was 80 years (range 65-95), median Montreal Cognitive Assessment score 20/30 (range 13-26), 58% were men. Participants received a median of 31 (IQR = 22-40) therapy sessions out of a possible maximum of 50. Participants reported completing a mean 121 minutes/week of PrAISED activity outside of supervised sessions. Primary outcome data were available for 149 (intervention) and 141 (control) participants. There was no difference in DAD scores between groups: adjusted mean difference -1.3/100, 95% Confidence Interval (-5.2 to +2.6); Cohens d effect size -0.06 (-0.26 to +0.15); p=0.5. Upper 95% confidence intervals excluded small to moderate effects on any of the range of secondary outcome measures. Between months 4 and 15 there were 79 falls in the intervention group and 200 falls in the control group, adjusted incidence rate ratio 0.78 (0.5 to 1.3); p= 0.3. Conclusion: The intensive PrAISED programme of exercise and functional activity training did not improve ADLs, physical activity, quality of life, reduce falls or improve any other secondary health status outcomes even though uptake was good. Future research should consider alternative approaches to risk reduction and ability maintenance. Trial registration: ISRCTN15320670 . Funding: National Institute for Health and Care Research

“Crack on”: a qualitative study of care home managers experiences and responses to system-led setbacks during the crisis of the COVID-19 Pandemic in England (preprint)

Objectives To explore care home managers’ experiences of systems working with various organisations, including statutory, third sector and private, during the second wave of the COVID-19 pandemic from April 2020 to January 2021 Design An exploratory qualitative interview study using a systems theory approach focussing on the intersections of relationship interdependencies with other organisations. Setting Conducted remotely with care home managers and key advisors who had worked since the start of the pandemic in/with care homes for older people across the East Midlands, UK. Participants  8 care home managers and 2 end-of-life advisors who participated during the second wave of the pandemic from November 2020. A total of 18 care home managers participated from April 2020 to January 2021 Results Four organisational relationship interdependencies were identified: care practices, resources governance and wise working. Managers identified changes in their care practices as a shift towards the normalisation of care, with an emphasis on navigating pandemic restrictions to fit the context. Resources such as staffing, specialist reviews, pharmaceutical and equipment supplies were challenged, leading to a sense of precarity and tension. National polices and local guidance were fragmented, complex and disconnected from the reality of managing a care home. As a response a highly pragmatic reflexive style of management was identified which encompassed the use of mastery to navigate and in some cases circumvent official systems and mandates. Managers’ experience of persistent and multiple setbacks were viewed as negative and confirmed their views that care homes as a sector ere marginalised by policy makers and statutory bodies. Conclusions Interactions with various organisations shaped the ways in which care home managers responded to and sought to maximise residents and staff well-being. Some relationships dissolved over time, such as when local business and schools returned to normal obligations. Other newly formed relationships became more robust including those with other care home managers, families, and hospices. Significantly, most managers viewed their relationship with local authority and national statutory bodies as detrimental to effective working, leading to a sense of increased mistrust and ambiguity. Key opportunities were lost to effectively engage the care home sector by statutory organisations who were perceived as relying excessively on mandate and regulation.

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

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 empirically gathered in people living with dementia. Objective. This study aims to identify the causes and effects of COVID-19-related deconditioning in people living with dementia. Design. Longitudinal phenomenological qualitative study. Subjects. Participants living with dementia, their carers and therapists involved in the Promoting Activity, Independence and Stability in Early Dementia (PrAISED) process evaluation during the COVID-19 pandemic. Methods. Qualitative interviews with participants were conducted remotely at two time points. The data were analysed through deductive thematic analysis. Results. Twenty-four participants living with dementia, 19 carers and 15 therapists took part in the study. 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 still remains a challenge.