Assessing the pool activity level (PAL) checklist for use with people with hearing and vision loss.

BACKGROUND: The PAL is a career-completed assessment that indexes cognitive functional ability to inform individualised support. As hearing and vision loss are prevalent, we assessed the PAL for potential bias with hearing or vision impairment. METHODS: We collected PAL responses for 333 adults aged over 60 years in the UK, France, Canada, Greece and Cyprus. All participants had normal cognition based on self-reported status and normal range scores on a cognitive screening test. Using a Kruskal-Wallis test, we compared PAL item response distributions for people with assessed hearing or vision loss compared to those with normal sensory function. RESULTS: There were no differences in response distributions between hearing or vision impaired groups versus those with normal sensory function on any PAL item. CONCLUSION: The PAL reliably indexes cognitive functional ability and may be used to inform support tailored to individual cognitive level amongst older adults with prevalent hearing and vision impairments.

Implementing a home-based personalised cognitive rehabilitation intervention for people with mild-to-moderate dementia: GREAT into Practice.

BACKGROUND: Evidence-based rehabilitative interventions, if widely implemented, could equip people with dementia and their families to manage life with the condition and reduce the need for health and care services. The aim of this translational study, building on evidence from the GREAT randomised controlled trial, was to develop a foundation for implementing the GREAT Cognitive Rehabilitation intervention in community-based services for people with mild-to-moderate dementia. METHODS: Key elements of the implementation strategy were identifying and supporting managerial and clinical leadership, conducting collaborative planning and target-setting, training and supporting practitioners, and providing external facilitation. We developed implementation plans with, and trained staff in, 14 organisations. We subsequently worked closely with 11 of these, 10 National Health Service organisations and one private home care provider, to support practitioners to deliver GREAT Cognitive Rehabilitation over a 12-month period. Outcome evaluation examined the perspectives of local steering group members, practitioners and service users, and the reach, effectiveness and cost of the intervention. RESULTS: Implementation was disrupted by the COVID-19 pandemic, but six organisations completed at least six months of intervention delivery. Forty-one practitioners, mainly occupational therapists, provided the intervention, and 54 people with dementia completed a course of GREAT Cognitive Rehabilitation. Goal attainment by people with dementia exceeded levels of improvement seen in the original trial. People with dementia, carers, practitioners and steering group members all evaluated the intervention positively, and economic analysis indicated that the intervention could be provided at modest cost. However, we identified a range of mainly organisational barriers that impeded implementation and limited the potential for sustainability. CONCLUSIONS: GREAT Cognitive Rehabilitation benefits people with dementia, can be delivered effectively at modest cost in routine services, and is viewed positively by people with dementia, family carers and practitioners. To fully realise these benefits and achieve widespread and sustainable implementation, however, requires sufficient resources and a reorientation of service priorities towards preventive and rehabilitative approaches. TRIAL REGISTRATION: National Institute for Health Research (NIHR) Central Portfolio Management System, registration number 38994.

Implementation processes in a cognitive rehabilitation intervention for people with dementia: a complexity-informed qualitative analysis.

OBJECTIVES: Healthcare is often delivered through complex interventions. Understanding how to implement these successfully is important for optimising services. This article demonstrates how the complexity theory concept of 'self-organisation' can inform implementation, drawing on a process evaluation within a randomised controlled trial of the GREAT (Goal-oriented cognitive Rehabilitation in Early-stage Alzheimer's and related dementias: a multi-centre single-blind randomised controlled Trial) intervention which compared a cognitive rehabilitation intervention for people with dementia with usual treatment. DESIGN: A process evaluation examined experiences of GREAT therapists and participants receiving the intervention, through thematic analysis of a focus group with therapists and interviews with participants and their carers. Therapy records of participants receiving the intervention were also analysed using adapted framework analysis. Analysis adopted a critical realist perspective and a deductive-inductive approach to identify patterns in how the intervention operated. SETTING: The GREAT intervention was delivered through home visits by therapists, in eight regions in the UK. PARTICIPANTS: Six therapists took part in a focus group, interviews were conducted with 25 participants and 26 carers, and therapy logs for 50 participants were analysed. INTERVENTION: A 16-week cognitive rehabilitation programme for people with mild-to-moderate dementia. RESULTS: 'Self-organisation' of the intervention occurred through adaptations made by therapists. Adaptations included simplifying the intervention for people with greater cognitive impairment, and extending it to meet additional needs. Relational work by therapists produced an emergent outcome of 'social support'. Self-organised aspects of the intervention were less visible than formal components, but were important aspects of how it operated during the trial. This understanding can help to inform future implementation. CONCLUSIONS: Researchers are increasingly adopting complexity theory to understand interventions. This study extends the application of complexity theory by demonstrating how 'self-organisation' was a useful concept for understanding aspects of the intervention that would have been missed by focusing on formal intervention components. Analysis of self-organisation could enhance future process evaluations and implementation studies. TRIAL REGISTRATION NUMBER: ISRCTN21027481.

Goal-oriented cognitive rehabilitation for early-stage Alzheimer's and related dementias: the GREAT RCT.

BACKGROUND: Cognitive rehabilitation (CR) is an individualised, person-centred intervention for people with mild to moderate dementia that addresses the impact of cognitive impairment on everyday functioning. OBJECTIVES: To determine whether or not CR is a clinically effective and cost-effective intervention for people with mild to moderate Alzheimer's disease or vascular or mixed dementia, and their carers. DESIGN: This multicentre randomised controlled trial compared CR with treatment as usual (TAU). Following a baseline assessment and goal-setting to identify areas of everyday functioning that could be improved or better managed, participants were randomised (1 : 1) via secure web access to an independent randomisation centre to receive either TAU or CR and followed up at 3 and 9 months post randomisation. SETTING: Community. PARTICIPANTS: Participants had an International Classification of Diseases, Tenth Edition, diagnosis of Alzheimer's disease or vascular or mixed dementia, had mild to moderate cognitive impairment (Mini Mental State Examination score of ≥ 18 points), were stable on medication if prescribed, and had a family carer who was willing to contribute. The exclusion criteria were people with a history of brain injury or other neurological disorder and an inability to speak English. To achieve adequate power, we needed 350 people to complete the trial, with 175 people in each trial arm. INTERVENTION: Cognitive rehabilitation consisted of 10 therapy sessions over 3 months, followed by four maintenance sessions over 6 months, delivered in participants' homes. The therapists were nine occupational therapists and one nurse. OUTCOME MEASURES: The primary outcome was self-reported goal attainment at 3 months. Goal attainment was also assessed at 9 months. Carers provided independent ratings of goal attainment at both time points. The secondary outcomes were participant quality of life, mood, self-efficacy and cognition, and carer stress, health status and quality of life. The assessments at 3 and 9 months were conducted by researchers who were blind to the participants' group allocation. RESULTS: A total of 475 participants were randomised (CR arm, n = 239; TAU arm, n = 236), 427 participants (90%) completed the trial and 426 participants were analysed (CR arm, n = 208, TAU arm, n = 218). At 3 months, there were statistically significant large positive effects for participant-rated goal attainment [mean change in the CR arm: 2.57; mean change in the TAU arm: 0.86; Cohen'sd = 0.97, 95% confidence interval (CI) 0.75 to 1.19], corroborated by carer ratings (Cohen'sd = 1.11, 95% CI 0.89 to 1.34). These effects were maintained at 9 months for both the participant ratings (Cohen's d = 0.94, 95% CI 0.71 to 1.17) and the carer ratings (Cohen's d = 0.96, 95% CI 0.73 to 1.20). There were no significant differences in the secondary outcomes. In the cost-utility analyses, there was no evidence of cost-effectiveness in terms of gains in the quality-adjusted life-years (QALYs) of the person with dementia (measured using the DEMentia Quality Of Life questionnaire utility score) or the QALYs of the carer (measured using the EuroQol-5 Dimensions, three-level version) from either cost perspective. In the cost-effectiveness analyses, by reference to the primary outcome of participant-rated goal attainment, CR was cost-effective from both the health and social care perspective and the societal perspective at willingness-to-pay values of £2500 and above for improvement in the goal attainment measure. There was no evidence on the cost-effectiveness of the self-efficacy measure (the Generalized Self-Efficacy Scale) from either cost perspective. LIMITATIONS: Possible limitations arose from the non-feasibility of using observational outcome measures, the lack of a general measure of functional ability and the exclusion of people without a carer or with rarer forms of dementia. CONCLUSIONS: Cognitive rehabilitation is clinically effective in enabling people with early-stage dementia to improve their everyday functioning in relation to individual goals targeted in the therapy sessions. FUTURE WORK: Next steps will focus on the implementation of CR into NHS and social care services and on extending the approach to people with rarer forms of dementia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN21027481. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 10. See the NIHR Journals Library website for further project information.

BACKGROUND: Cognitive rehabilitation (CR) is a personalised intervention to help people with early-stage dementia to manage everyday activities. This individualised therapy is conducted in people's own homes over several sessions. A therapist works with the person and the carer to identify realistic and relevant goals, plan how to tackle these and support people in achieving them. Previous small studies suggested that CR could be beneficial. METHODS: The Goal-oriented cognitive Rehabilitation in Early-stage Alzheimer's and related dementias: multicentre single-blind randomised controlled Trial (GREAT) was run in eight centres to find out whether or not CR improves everyday functioning. Participants were in the early stages of having Alzheimer's disease, vascular dementia or mixed dementia, with a family carer involved. At the first assessment, participants identified areas in which they would like to see improvements, and set goals. Participants and carers rated how well participants were currently doing in relation to these goals and completed questionnaires, for example about mood and quality of life. Participants were then randomly selected to either receive CR or continue with treatment as usual (TAU). CR consisted of 10 weekly sessions with the therapist over 3 months, followed by four sessions over the next 6 months. Participants were reassessed after 3 and 9 months. RESULTS: We included 475 participants, and 427 participants (90%) completed the trial (209 participants in the CR arm and 218 participants in the TAU arm). After 3 months, the ratings by both participants and carers in the CR group showed that participants were doing significantly better in relation to their goals, and this was maintained 6 months later. Ratings for the TAU-arm participants did not improve significantly. There were no other differences between the groups. There was a strong economic case for CR. CONCLUSIONS: Cognitive rehabilitation is effective in enabling people with early-stage dementia to improve their everyday functioning in relation to individual goals targeted in the therapy sessions. Next steps will focus on the implementation of CR into NHS and social care services.

Individual goal-oriented cognitive rehabilitation to improve everyday functioning for people with early-stage dementia: A multicentre randomised controlled trial (the GREAT trial).

OBJECTIVES: To determine whether individual goal-oriented cognitive rehabilitation (CR) improves everyday functioning for people with mild-to-moderate dementia. DESIGN AND METHODS: Parallel group multicentre single-blind randomised controlled trial (RCT) comparing CR added to usual treatment (CR) with usual treatment alone (TAU) for people with an ICD-10 diagnosis of Alzheimer, vascular or mixed dementia, and mild-to-moderate cognitive impairment (Mini-Mental State Examination [MMSE] score ≥ 18), and with a family member willing to contribute. Participants allocated to CR received 10 weekly sessions over 3 months and four maintenance sessions over 6 months. Participants were followed up 3 and 9 months post randomisation by blinded researchers. The primary outcome was self-reported goal attainment at 3 months. Secondary outcomes at 3 and 9 months included informant-reported goal attainment, quality of life, mood, self-efficacy, and cognition and study partner stress and quality of life. RESULTS: We randomised (1:1) 475 people with dementia; 445 (CR = 281) were included in the intention to treat analysis at 3 months and 426 (CR = 208) at 9 months. At 3 months, there were statistically significant large positive effects for participant-rated goal attainment (d = 0.97; 95% CI, 0.75-1.19), corroborated by informant ratings (d = 1.11; 95% CI, 0.89-1.34). These effects were maintained at 9 months for both participant (d = 0.94; 95% CI, 0.71-1.17) and informant (d = 0.96; 95% CI, 0.73-1.2) ratings. The observed gains related to goals directly targeted in the therapy. There were no significant differences in secondary outcomes. CONCLUSIONS: CR enables people with early-stage dementia to improve their everyday functioning in relation to individual goals targeted in the therapy.

Goal-oriented cognitive rehabilitation in early-stage dementia: study protocol for a multi-centre single-blind randomised controlled trial (GREAT).

BACKGROUND: Preliminary evidence suggests that goal-oriented cognitive rehabilitation (CR) may be a clinically effective intervention for people with early-stage Alzheimer's disease, vascular or mixed dementia and their carers. This study aims to establish whether CR is a clinically effective and cost-effective intervention for people with early-stage dementia and their carers. METHODS/DESIGN: In this multi-centre, single-blind randomised controlled trial, 480 people with early-stage dementia, each with a carer, will be randomised to receive either treatment as usual or cognitive rehabilitation (10 therapy sessions over 3 months, followed by 4 maintenance sessions over 6 months). We will compare the effectiveness of cognitive rehabilitation with that of treatment as usual with regard to improving self-reported and carer-rated goal performance in areas identified as causing concern by people with early-stage dementia; improving quality of life, self-efficacy, mood and cognition of people with early-stage dementia; and reducing stress levels and ameliorating quality of life for carers of participants with early-stage dementia. The incremental cost-effectiveness of goal-oriented cognitive rehabilitation compared to treatment as usual will also be examined. DISCUSSION: If the study confirms the benefits and cost-effectiveness of cognitive rehabilitation, it will be important to examine how the goal-oriented cognitive rehabilitation approach can most effectively be integrated into routine health-care provision. Our aim is to provide training and develop materials to support the implementation of this approach following trial completion.

Assessing the validity and reliability of the Pool Activity Level (PAL) Checklist for use with older people with dementia.

Activity is key to maintaining physical and mental health and well-being. However, as dementia affects the ability to engage in activity, care-givers can find it difficult to provide appropriate activities. The Pool Activity Level (PAL) Checklist guides the selection of appropriate, personally meaningful activities. The aim of this study was to assess the reliability and validity of the PAL Checklist when used with older people with dementia. A postal questionnaire sent to activity providers assessed content validity. Validity and reliability were measured in a sample of 60 older people with dementia. The questionnaire response rate was 83% (102/122). Most respondents felt no important items were missing. Seven of the nine activities were ranked as 'very important' or 'essential' by at least 77% of the sample, indicating very good content validity. Correlation with measures of cognition, severity of dementia and activity performance demonstrated strong concurrent validity. Inter-item correlation indicated strong construct validity. Cronbach's alpha coefficient measured internal consistency as excellent (0.95). All items achieved acceptable test-retest reliability, and the majority demonstrated acceptable inter-rater reliability. We conclude that the PAL Checklist demonstrates adequate validity and reliability when used with older people with dementia and appears a useful tool for a variety of care settings.