A predictive model of carer resilience in dementia family caregiving: A structural equation modelling approach.

OBJECTIVES: This study aimed to investigate the mediating effects of quality of the caregiving relationship and other carer and person with dementia variables in predicting carer resilience over time. METHOD: Carers of people with mild and moderate dementia in community settings completed baseline (n = 176 dyads) and six-month follow-up assessments (n = 139 dyads). Causal mediation analysis was conducted using Pearson Correlation and Structural Equation Modelling (SEM) to examine longitudinal predictors of carer resilience, and the effect of several mediating person with dementia, and carer factors on carer resilience over time. RESULTS: At 6-month follow-up, higher levels of carer resilience were longitudinally correlated with higher ratings of perceived relationship quality by people with dementia (r = 0.53 p ≤ 0.01), and lower levels of emotional distress symptoms by carer's (r = -0.59 p ≤ 0.01). Mediation analyses showed that people with dementia perspectives of the quality of the caregiving relationship mediated the relationship between carer distress specific to neuropsychiatric symptoms (ß = -0.32, p ≤ 0.001) and carer resilience (ß = 0.53, p ≤ 0.001) over time. The final SEM provided a good fit for the data (X 2  = 0.12, p = 0.72, CFI = 1.00, NFI = 0.99, and Root Mean Square Error of Approximation = 0.001). CONCLUSION: Higher ratings of perceived relationship quality by people with dementia, and lower levels of carer emotional distress predicted higher carer resilience at follow-up. People with dementia perspectives of the quality of the caregiving relationship mediated the relationship between carer distress specific to neuropsychiatric symptoms and carer resilience over time. Our findings indicate that interventions aimed at strengthening the caregiving relationship might have a protective long-term effect for carer resilience in dementia caregiving.

A Web-Based Self-management App for Living Well With Dementia: User-Centered Development Study.

BACKGROUND: Self-management, autonomy, and quality of life are key constructs in enabling people to live well with dementia. This population often becomes isolated following diagnosis, but it is important for them to feel encouraged to maintain their daily activities and stay socially active. Promoting Independence in Dementia (PRIDE) fosters social inclusion and greater dementia self-management through an interactive handbook. OBJECTIVE: This study aimed to develop a paper-based PRIDE manual on a web-based platform. METHODS: Two overarching stages were used to create the web-based version of PRIDE. The first was Preliminary Development, which encompassed tendering, preliminary development work, consultations, beta version of the website, user testing and consultation on beta version, and production of the final web-based prototype. The second stage was Development of the Final PRIDE App, which included 2 sprints and further user testing. RESULTS: Through a lengthy development process, modifications were made to app areas such as the log-in process, content layout, and aesthetic appearance. Feedback from the target population was incorporated into the process to achieve a dementia-friendly product. The finished PRIDE app has defined areas for reading dementia-related topics, creating activity plans, and logging these completed activities. CONCLUSIONS: The PRIDE app has evolved from its initial prototype into a more dementia-friendly and usable program that is suitable for further testing. The finished version will be tested in a reach, effectiveness, adoption, implementation, and maintenance study, with its potential reach, effectiveness, and adoption explored. Feedback gathered during the reach, effectiveness, adoption, implementation, and maintenance study will lead to any further developments in the app to increase its applicability to the target audience and usability.

A feasibility randomised control trial of individual cognitive stimulation therapy for dementia: impact on cognition, quality of life and positive psychology.

OBJECTIVES: This study aimed to evaluate the feasibility of a 14-session programme of individual Cognitive Stimulation Therapy (iCST) for people with dementia (PWD). It addressed potential limitations in previous literature of iCST and evaluated possible impact on cognition, quality of life (QoL) and positive psychology. METHOD: The 14-session iCST programme was developed using existing manuals for group and individual CST and consultation with experts in the field. Thirty-three PWD were recruited from care homes and randomly assigned to iCST (14, 45-min sessions) or treatment as usual (TAU) over seven weeks. Outcomes measures were assessed at baseline and follow-up after the intervention. RESULTS: The intervention appeared feasible with high attendance to sessions, minimal levels of attrition, and ease of recruitment. Analysis of covariance indicated significant improvements in cognition (Alzheimer's Disease Assessment Scale-Cognitive subscale) for PWD receiving iCST compared to TAU. There were no significant differences between groups on follow-up scores on the standardised Mini Mental State Examination, measures of positive psychology or self- and proxy- reported QoL. CONCLUSION: A 14-session programme of iCST delivered by professionals was feasible and acceptable to PWD and may provide benefits to cognition. A larger randomised control trial would be necessary to fully evaluate intervention impact on cognition, as well as QoL and positive psychology.

Cognitive stimulation therapy (CST) for dementia: a systematic review of qualitative research.

INTRODUCTION: Cognitive Stimulation Therapy (CST) is a well-established intervention for people with dementia shown to improve cognition and quality of life. Past research includes development of a longer term 'maintenance CST' and an individual CST programme. Previous reviews of CST have focused on quantitative outcomes or excluded certain formats of CST. This review aimed to fill this gap by evaluating how the voices of facilitators, carers and people with dementia in qualitative studies of CST can contribute to our understanding of its implementation and how it is experienced. METHODS: The current systematic review explored the experience and perspectives of people with dementia, facilitators and carers. Thematic Analysis was used to analyse this data, alongside guidance on synthesising qualitative findings. RESULTS: A systematic literature search retrieved 10 relevant studies using qualitative methodology. Eighteen themes were generated, which were grouped into three categories: 'Acceptability and feasibility', 'Features of CST' and 'Key outcomes'. CONCLUSIONS: To our knowledge, this is the only review to explore solely qualitative studies of CST. Findings provided insight into the shared features, outcomes and factors affecting implementation, and suggested theories for discrepancies between quantitative and qualitative findings in the literature. Some of the common themes were also in keeping with past reviews.

Feasibility and acceptability evaluation of the Promoting Independence in Dementia (PRIDE) intervention for living well with dementia.

OBJECTIVES: Post-diagnostic psychosocial interventions could play an important role in supporting people with mild dementia remain independent. The Promoting Independence in Dementia (PRIDE) intervention was developed to address this. METHOD: The mixed methods non-randomized, pre-post feasibility study occurred across England. Facilitators were recruited from the voluntary sector and memory services. Participants and their supporters took part in the three-session intervention. Outcome measures were collected at baseline and follow-up. To evaluate acceptability, focus groups and interviews were conducted with a subsample of participants and facilitators. RESULTS: Contextual challenges to delivery including national research governance changes, affected recruitment of study sites. Thirty-four dyads consented, with 14 facilitators providing the intervention. Dyads took part in at least two sessions (79%), and 73% in all three. Outcome measures were completed by 79% without difficulty, with minimal missing data. No significant changes were found on pre and post assessments. Post hoc analysis found moderate effect size improvements for self-management (SMAS instrument) in people with dementia (d = 0.41) and quality of life (EQ5D measure) in carers (d = 0.40). Qualitative data indicated that dyads found PRIDE acceptable, as did intervention facilitators. CONCLUSIONS: The three-session intervention was well accepted by participant-dyads and intervention facilitators. A randomized controlled trial of PRIDE would need to carefully consider recruitment potential across geographically varied settings and site stratification according to knowledge of contextual factors, such as the diversity of post-diagnostic services across the country. Letting sites themselves be responsible for identifying suitable intervention facilitators was successful. The self-report measures showed potential to be included in the main trial.

Field-testing an iCST touch-screen application with people with dementia and carers: a mixed method study.

OBJECTIVES: To test the individual Cognitive Stimulation Therapy (iCST) application with people with dementia and carers in order to modify and refine the application, and improve its usability. In an iterative development process, two different prototypes were used to elicit the subjects' views and preferences. This application may address the current need for more innovative approaches to support people with dementia and their carers. METHODS: An opportunistic sample of 13 people with dementia and 13 carers participated in four focus groups and ten semi-structured interviews to obtain feedback in key areas, including the layout and content of the application, and the experience of its use as a dyad. Data were audio-recorded, transcribed and analysed thematically. An additional 18 people with dementia and 16 carers completed a short usability and acceptability questionnaire regarding a subsequent version of the iCST application prototype. RESULTS: Most participants expressed enthusiasm about the iCST application, its usability, design, and content. Participants highlighted the importance of adaptability to individual preferences, indicating a need for a wider range of activities and flexibility in the use of the application. Furthermore, participants reported perceived benefits, including mental stimulation, quality time spent together, and enjoyment. The application was rated slightly better by carers than people with dementia in terms of usability and acceptability. CONCLUSIONS: This study gives insights from people with dementia and carers concerning the usability, feasibility, and perceived benefits of the iCST application. The feedback will be incorporated in an updated version of the iCST application for commercial release.

Involvement of People With Dementia in the Development of Technology-Based Interventions: Narrative Synthesis Review and Best Practice Guidelines.

BACKGROUND: Technology can be helpful in supporting people with dementia in their daily lives. However, people with dementia are often not fully involved in the development process of new technology. This lack of involvement of people with dementia in developing technology-based interventions can lead to the implementation of faulty and less suitable technology. OBJECTIVE: This systematic review aims to evaluate current approaches and create best practice guidelines for involving people with dementia in developing technology-based interventions. METHODS: A systematic search was conducted in January 2019 in the following databases: EMBASE (Excerpta Medica database), PsycINFO, MEDLINE (Medical Literature Analysis and Retrieval System Online), CINAHL (Cumulated Index to Nursing and Allied Health Literature), and Web of Science. The search strategy included search terms in 3 categories: dementia, technology, and involvement in development. Narrative synthesis wove the evidence together in a structured approach. RESULTS: A total of 21 studies met the inclusion criteria. Most studies involved people with dementia in a single phase, such as development (n=10), feasibility and piloting (n=7), or evaluation (n=1). Only 3 studies described involvement in multiple phases. Frequently used methods for assessing involvement included focus groups, interviews, observations, and user tests. CONCLUSIONS: Most studies concluded that it was both necessary and feasible to involve people with dementia, which can be optimized by having the right prerequisites in place, ensuring that technology meets standards of reliability and stability, and providing a positive research experience for participants. Best practice guidelines for the involvement of people with dementia in developing technology-based interventions are described.

Evaluation of Pharmacist Medication Review Service in an Outpatient Heart Failure Clinic.

PURPOSE: The purpose of this study was to evaluate the impact of pharmacist medication reviews on drug-related problems (DRPs) in a population with ambulatory heart failure (HF). METHODS: The HF pharmacist medication review service incorporated a comprehensive medication review note provided to the cardiologist in a HF clinic. A retrospective chart review was performed on 64 control patients with no previous pharmacist review and 64 intervention patients who had a pharmacist medication review. The primary end point was the number of DRPs identified per patient in the intervention group 2 weeks after pharmacist medication review compared to the number of DRPs identified per patient in the control group. RESULTS: The average DRPs per patient was reduced from 2.80 to 1.95 in intervention group after pharmacist intervention. There was a statistically significant difference between the average DRPs per patient in the control and intervention groups, 2.55 DRPs versus 1.95 DRPs per patient, respectively (P = .016). Medication adherence (78%), renal dosing (67%), hypertension (58%), and HF DRPs (55%) had the highest acceptance rate. The majority of DRP recommendations in the intervention (87%) and control groups (87%) were high-impact recommendations. CONCLUSIONS: Pharmacist medication reviews in an ambulatory HF clinic lead to significantly fewer DRPs.

Interacting with television in one's own home: The development of a cognitive stimulation television pilot episode for older people with dementia (Innovative Practice).

Cognitive Stimulation Therapy is a well-established, cognition-based intervention for people with mild to moderate dementia. However, it can be difficult for older people with dementia, particularly those living alone, to access Cognitive Stimulation Therapy groups in the community. Television offers familiar technology with potential to transmit material similar to that used in Cognitive Stimulation Therapy groups. Consequently, an interactive pilot television episode of Cognitive Stimulation Therapy was devised that adheres to the key principles and session themes of group Cognitive Stimulation Therapy. Consideration was given to the suitability of resources, on-screen visual cues, time given for the person with dementia viewing to process, consider and answer questions, possible interactions with the audience, and the grading of activities. The aim of the pilot episode was to be accessible in the home of the person with dementia, by themselves or with a caregiver, with the potential for enjoyment and cognitive stimulation similar to that seen in group Cognitive Stimulation Therapy.

Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial.

BACKGROUND: Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. METHODS/DESIGN: PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month's post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. DISCUSSION: This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial. TRIAL REGISTRATION: ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

The development of the Promoting Independence in Dementia (PRIDE) intervention to enhance independence in dementia.

OBJECTIVE: Support after a diagnosis of dementia may facilitate better adjustment and ongoing management of symptoms. The aim of the Promoting Independence in Dementia (PRIDE) study was to develop a postdiagnostic social intervention to help people live as well and as independently as possible. The intervention facilitates engagement in evidence-based stimulating cognitive, physical and social activities. METHODS: Theories to promote adjustment to a dementia diagnosis, including theories of social learning and self-efficacy, were reviewed alongside self-management and the selective optimization model, to form the basis of the intervention. Analyses of two longitudinal databases of older adults, and qualitative analyses of interviews of older people, people with dementia, and their carers about their experiences of dementia, informed the content and focus of the intervention. Consensus expert review involving stakeholders was conducted to synthesize key components. Participants were sourced from the British NHS, voluntary services, and patient and public involvement groups. A tailored manual-based intervention was developed with the aim for this to be delivered by an intervention provider. RESULTS: Evidence-based stimulating cognitive, physical, and social activities that have been shown to benefit people were key components of the proposed PRIDE intervention. Thirty-two participants including people with dementia (n=4), carers (n=11), dementia advisers (n=14), and older people (n=3) provided feedback on the drafts of the intervention and manual. Seven topics for activities were included (eg, "making decisions" and "getting your message across"). The manual outlines delivery of the intervention over three sessions where personalized profiles and plans for up to three activities are developed, implemented, and reviewed. CONCLUSION: A manualized intervention was constructed based on robust methodology and found to be acceptable to participants. Consultations with stakeholders played a key role in shaping the manualized PRIDE intervention and its delivery. Unlike most social interventions for dementia, the target audience for our intervention is the people with dementia themselves.

Cognitive Stimulation Therapy for Dementia.

Cognitive stimulation therapy has proven to be both an effective and enjoyable psychological treatment for people with dementia. Over the past 20 years, cognitive stimulation therapy has grown from a national, localized treatment in the UK to a more global phenomenon currently being used in more than 25 countries around the world. Much has been accomplished during the cognitive stimulation therapy journey and there is still much to be explored; it is a dynamic field. This article provides an overview of cognitive stimulation therapy by elaborating on its background, evidence, international work, and future directions.

The impact of individual Cognitive Stimulation Therapy (iCST) on cognition, quality of life, caregiver health, and family relationships in dementia: A randomised controlled trial.

BACKGROUND: Cognitive stimulation therapy (CST) is a well-established group psychosocial intervention for people with dementia. There is evidence that home-based programmes of cognitive stimulation delivered by family caregivers may benefit both the person and the caregiver. However, no previous studies have evaluated caregiver-delivered CST. This study aimed to evaluate the effectiveness of a home-based, caregiver-led individual cognitive stimulation therapy (iCST) program in (i) improving cognition and quality of life (QoL) for the person with dementia and (ii) mental and physical health (well-being) for the caregiver. METHODS AND FINDINGS: A single-blind, pragmatic randomised controlled trial (RCT) was conducted at eight study sites across the United Kingdom. The intervention and blinded assessment of outcomes were conducted in participants' homes. Three hundred fifty-six people with mild to moderate dementia and their caregivers were recruited from memory services and community mental health teams (CMHTs). Participants were randomly assigned to iCST (75, 30-min sessions) or treatment as usual (TAU) control over 25 wk. iCST sessions consisted of themed activities designed to be mentally stimulating and enjoyable. Caregivers delivering iCST received training and support from an unblind researcher. Primary outcomes were cognition (Alzheimer's Disease Assessment Scale-cognitive [ADAS-Cog]) and self-reported QoL (Quality of Life Alzheimer's Disease [QoL-AD]) for the person with dementia and general health status (Short Form-12 health survey [SF-12]) for the caregiver. Secondary outcomes included quality of the caregiving relationship from the perspectives of the person and of the caregiver (Quality of the Carer Patient Relationship Scale) and health-related QoL (European Quality of Life-5 Dimensions [EQ-5D]) for the caregiver. Intention to treat (ITT) analyses were conducted. At the post-test (26 wk), there were no differences between the iCST and TAU groups in the outcomes of cognition (mean difference [MD] = -0.55, 95% CI -2.00-0.90; p = 0.45) and self-reported QoL (MD = -0.02, 95% CI -1.22-0.82; p = 0.97) for people with dementia, or caregivers' general health status (MD = 0.13, 95% CI -1.65-1.91; p = 0.89). However, people with dementia receiving iCST rated the relationship with their caregiver more positively (MD = 1.77, 95% CI 0.26-3.28; p = 0.02), and iCST improved QoL for caregivers (EQ-5D, MD = 0.06, 95% CI 0.02-0.10; p = 0.01). Forty percent (72/180) of dyads allocated to iCST completed at least two sessions per week, with 22% (39/180) completing no sessions at all. Study limitations include low adherence to the intervention. CONCLUSIONS: There was no evidence that iCST has an effect on cognition or QoL for people with dementia. However, participating in iCST appeared to enhance the quality of the caregiving relationship and caregivers' QoL. TRIAL REGISTRATION: The iCST trial is registered with the ISRCTN registry (identified ISRCTN 65945963, URL: DOI 10.1186/ISRCTN65945963).

The experiences of people with dementia and their carers participating in individual cognitive stimulation therapy.

BACKGROUND: The carer-delivered individual cognitive stimulation therapy (iCST) was developed to improve cognition and quality of life of people with dementia. This study aims to explore people with dementia and family carers' concepts of mental stimulation and experiences of participating in the iCST intervention. METHODS: A sub-sample of 23 dyads of people with dementia and their family carers who completed the iCST intervention took part in semi-structured in-depth interviews. Data were analysed using framework analysis. RESULTS: Three main themes emerged, 'Concepts of mental stimulation', 'Experiencing changes in everyday life as a result of participating in iCST' and 'Carer adherence to the intervention' along with 10 sub-themes. The overall experience of participating in iCST was described as having opportunities to engage in enjoyable mentally stimulating activities, motivation to stay active and bringing people with dementia and their carers 'together'. Family carers mentioned that finding time to do the sessions and their relatives being reluctant to engage in the activities could hinder their participation in the intervention. CONCLUSIONS: People with dementia and their family carers found iCST stimulating and enjoyable, but many had difficulty delivering all the sessions as planned. Family carers suggested that providing extra support by involving other people in delivering the intervention may help to improve adherence to the intervention. iCST may be a useful tool to encourage people with dementia and their carers to communicate. Copyright © 2017 John Wiley & Sons, Ltd.

Cognitive leisure activities and future risk of cognitive impairment and dementia: systematic review and meta-analysis.

BACKGROUND: As life expectancies continue to rise, modifiable lifestyle factors that may prevent cognitive decline and dementia in later life become increasingly important in order to maintain quality of life in old age. METHODS: Five meta-analyses were conducted on data from papers identified in a systematic review. Studies were grouped according to outcomes (dementia, cognitive impairment including amnestic Mild Cognitive Impairment (aMCI), Mild Cognitive Impairment (MCI), and cognitive decline) and output (risk (RR), odds (OR), or hazard ratios (HR)). RESULTS: Nineteen studies met our inclusion criteria and quality assessments. Four of five meta-analyses showed significant associations between participation in cognitive leisure activities and reduced risk of cognitive impairment (OR = 0.69, 95% CI: 0.56-0.85) and dementia (HR = 0.58, 95% CI: 0.46-0.74; RR = 0.61, 95% CI: 0.42-0.90; OR = 0.78, 95% CI: 0.67-0.90). However, one pooled analysis of cognitive impairment studies did not reach significance (HR = 0.85, 95% CI: 0.71-1.02). Mentally stimulating leisure activities were significantly associated with later life cognition (ß = 0.11, p = 0.05), better memory (ß = 0.20, 95% CI: 0.11-0.29), speed of processing (ß = 0.37, 95% CI: 0.29-0.45), and executive functioning (ß = 0.23, 95% CI: 0.15-0.29), and less decline in overall cognition (ß = -0.23, p < 0.01), language (ß = -0.11, p < 0.05), and executive functioning (ß = -0.13, p < 0.05). Activities were also shown to reduce rate of cognitive decline (estimate = 0.03, SE = 0.01, p = 0.00). CONCLUSIONS: There is increasing evidence that participation in cognitively stimulating leisure activities may contribute to a reduction of risk of dementia and cognitive impairment in later life. Promoting involvement in such activities across lifespan could be an important focus for primary prevention strategies for governments and health services.

Field-testing phase of the development of individual cognitive stimulation therapy (iCST) for dementia.

BACKGROUND: Cognitive Stimulation Therapy (CST) groups for people with dementia are available nationally, and internationally through voluntary organisations, memory services, and in residential care settings. However, groups may not be accessible or best suited for all. Individual Cognitive Stimulation Therapy (iCST) has been developed to provide another means of accessing CST. METHODS: The programme was field tested by 22 dyads (carers and people with dementia). Dyads were trained in the iCST approach and provided with a manual and accompanying resources. Researchers contacted dyads weekly to provide support and gather adherence data. Quantitative feedback about each session was also collected using 'Monitoring Progress' forms. Upon completion of their allocation sessions, researchers interviewed dyads about their experience. In total, nine dyads were followed up. Inductive thematic analysis was performed on the qualitative data. The aims of field testing were to assess the feasibility of the programme, and the appropriateness of the iCST materials. RESULTS: Sixty-two percent of the themes received an overall 'high' rating, and the majority of activities were classed as 'low' difficulty. Common barriers to completing sessions were; lack of time, illness, and motivation. Carers felt the manual and resources were 'good' and easy to use. Benefits of the programme for the person included; improvements in communication, mood, and alertness. The programme also gave carers insight into the person's abilities and interests, and provided a new channel of communication. Little support was needed to deliver the programme. CONCLUSIONS: Implementation of the iCST intervention was feasible. However, the majority of dyads completed fewer than three sessions per week. The training and support package appeared to be suitable as carers were able to deliver the intervention without intensive support. Barriers occurred largely as a result of life commitments, rather than problems with the intervention itself. This study was limited by a high loss to follow up rate. The effectiveness and cost effectiveness of iCST were investigated in a large scale randomised controlled trial (RCT). TRIAL REGISTRATION: ISRCTN65945963 Date of trial registration: 05/05/2010.

Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial.

BACKGROUND: Group cognitive stimulation therapy programmes can benefit cognition and quality of life for people with dementia. Evidence for home-based, carer-led cognitive stimulation interventions is limited. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of carer-delivered individual cognitive stimulation therapy (iCST) for people with dementia and their family carers, compared with treatment as usual (TAU). DESIGN: A multicentre, single-blind, randomised controlled trial assessing clinical effectiveness and cost-effectiveness. Assessments were at baseline, 13 weeks and 26 weeks (primary end point). SETTING: Participants were recruited through Memory Clinics and Community Mental Health Teams for older people. PARTICIPANTS: A total of 356 caregiving dyads were recruited and 273 completed the trial. INTERVENTION: iCST consisted of structured cognitive stimulation sessions for people with dementia, completed up to three times weekly over 25 weeks. Family carers were supported to deliver the sessions at home. MAIN OUTCOME MEASURES: Primary outcomes for the person with dementia were cognition and quality of life. Secondary outcomes included behavioural and psychological symptoms, activities of daily living, depressive symptoms and relationship quality. The primary outcome for the family carers was mental/physical health (Short Form questionnaire-12 items). Health-related quality of life (European Quality of Life-5 Dimensions), mood symptoms, resilience and relationship quality comprised the secondary outcomes. Costs were estimated from health and social care and societal perspectives. RESULTS: There were no differences in any of the primary outcomes for people with dementia between intervention and TAU [cognition: mean difference -0.55, 95% confidence interval (CI) -2.00 to 0.90; p-value = 0.45; self-reported quality of life: mean difference -0.02, 95% CI -1.22 to 0.82; p-value = 0.97 at the 6-month follow-up]. iCST did not improve mental/physical health for carers. People with dementia in the iCST group experienced better relationship quality with their carer, but there was no evidence that iCST improved their activities of daily living, depression or behavioural and psychological symptoms. iCST seemed to improve health-related quality of life for carers but did not benefit carers' resilience or their relationship quality with their relative. Carers conducting more sessions had fewer depressive symptoms. Qualitative data suggested that people with dementia and their carers experienced better communication owing to iCST. Adjusted mean costs were not significantly different between the groups. From the societal perspective, both health gains and cost savings were observed. CONCLUSIONS: iCST did not improve cognition or quality of life for people with dementia, or carers' physical and mental health. Costs of the intervention were offset by some reductions in social care and other services. Although there was some evidence of improvement in terms of the caregiving relationship and carers' health-related quality of life, iCST does not appear to deliver clinical benefits for cognition and quality of life for people with dementia. Most people received fewer than the recommended number of iCST sessions. Further research is needed to ascertain the clinical effectiveness of carer-led cognitive stimulation interventions for people with dementia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN65945963. FUNDING: This project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) programme and will be published in full in Health Technology Assessment; Vol. 19, No. 64. See the NIHR Journals Library website for further information.