No abstract

BackgroundCognitive 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 findingsA 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.ConclusionsThere 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 registrationThe iCST trial is registered with the ISRCTN registry (identified ISRCTN 65945963, URL: DOI 10.1186/ISRCTN65945963).

BackgroundGroup 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.ObjectivesTo 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).DesignA multicentre, single-blind, randomised controlled trial assessing clinical effectiveness and cost-effectiveness. Assessments were at baseline, 13 weeks and 26 weeks (primary end point).SettingParticipants were recruited through Memory Clinics and Community Mental Health Teams for older people.ParticipantsA total of 356 caregiving dyads were recruited and 273 completed the trial.InterventioniCST 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 measuresPrimary 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.ResultsThere 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.ConclusionsiCST 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 registrationCurrent Controlled Trials ISRCTN65945963.FundingThis project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 64. See the NIHR Journals Library website for further information.

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.

Donepezil has a beneficial effect on memory and may improve other cognitive deficits in patients with PD and cognitive impairment. However, variable tolerability in our sample underscores the need for careful monitoring when prescribing donepezil to patients with PD, especially with dosage increases.