Individual Cognitive Stimulation Therapy for dementia (iCST Trial)

• United Kingdom

Department of Health (DH)

1432102

01-07-2010

48

• Alzheimer’s disease and other dementias

Dementia, Cognitive Therapy,

‘BACKGROUND: Cognitive Stimulation Therapy (CST) as developed by this research group (Spector et al., 2003) is an effective 14 session group programme which improves cognition and quality of life for people with dementia and has been recommended by the NICE dementia guidelines (NICE, 2006).

DESIGN: Multicentre, pragmatic, single blind, randomised, 2 treatment arm (individual CST vs treatment as usual), controlled clinical trial over 26 weeks. The individual CST programme will be based on a modified CST manual the updated CST review, and a focus group consultation with people with dementia and their carers. The treatment as usual group (TAU) will not receive any additional intervention. Assessments will be: baseline (pre-CST); 13 weeks and 26 weeks.

TARGET POPULATION: People with dementia and their carers in community settings including memory clinics, the voluntary sector and day care.

HEALTH TECHNOLOGY BEING ASSESSED: Individual CST would be delivered by the family caregiver for 30 minutes, 3 times a week over 25 weeks . All sessions will be described in the manual and an accompanying DVD will have other material for each session such as music and visual cues (eg famous faces). Carers will receive a standardised training, and receive up to ten hours support including telephone support (initially weekly) and 3 visits. Qualitative interviews will be used to investigate the impact on the carer role and carer relationship

OUTCOMES: Primary outcome cognition and quality of life. Primary economic evaluation: cost-effectiveness analysis from a health and social care perspective and also a societal perspective, looking at comprehensive costs.

SAMPLE SIZE: This analysis will be based on intention to treat for the primary outcome cognition. A sample size of 260 will have 80% power to detect a SMD of 0.35 using a two group t-test with a 0.05 significance level comparing the individual CST and the TAU groups. Assuming 15% attrition we propose to recruit 306 people with dementia.

In the UK, over 700,000 older people have dementia. This leads to progressive intellectual deterioration, problems carrying out daily activities such as self care, social isolation and increasing difficulty interacting and communicating. Dementia also has an immense social and economic impact on health and social care services, and on family carers. Drug treatments have an important role in dementia care but in the UK they are limited to people with Alzheimer’s disease with moderately severe dementia, have a limited impact on the illness, and are not suitable for all patients. Psychological treatments for dementia such as reality orientation are widely used in the UK and internationally for several decades, but there has been little high quality research on their effectiveness. There is an urgent need to find useful interventions to help reduce the impact of dementia on people with dementia, carers and society. In the UK there is increasing recognition that psychological therapies for dementia should be made more available and the National Institute of Clinical Excellence has recommended that cognitive stimulation approaches should be made widely available for people with mild to moderate dementia. A new approach known as Cognitive Stimulation Therapy (CST) developed from a very detailed and systematic review of the evidence was used in a clinical trial involving 201 people with dementia in therapy groups. CST improved memory and quality of life and there are indications that long term CST could also help cognition for around six months. CST was also cost-effective and may also potentially reduce costs of care for example by delaying institutionalisation. In Italy and the USA research has also shown that individual sessions delivered by the family caregiver can also benefit cognition for up to six months. This study will be based upon individual CST sessions delivered by the caregiver evaluated in a large research trial comparing (a) usual care and (b) individual CST over six months looking at the effects on cognition, quality of life, and costs of care. We have spoken to people with dementia and their carers who are keen on having a version of CST which can be delivered by the carer particularly for people who are unable or unwilling to go out of the house and/or to attend groups. They also felt it could help the relationship between the carer and the person with dementia. Previous research has also shown that involving carers in delivering interventions can be beneficial for both. We will produce training manuals, to be made available to help other services and other carers to implement the same approaches. We will work closely with people with dementia, their carers, and voluntary organisations including ‘For Dementia’, the Alzheimer’s Society, and Age Concern. We will ensure CST is practical and appropriate for people with dementia. The applicants have expertise in dementia care research, clinical trials and health economics. If the study shows that individual CST is effective we would expect it to become a popular and widely used intervention for people with dementia and their carers.

• Clinical research