Abstract
BackgroundThe possibility of living well with a long-term condition has been identified as centrally relevant to the needs of people living with dementia. Growing numbers of people with early-stage dementia are contributing accounts that emphasise the benefits of actively engaging in managing the condition. Self-management interventions share the common objectives of educating about the condition, optimising well-being, enhancing control over the situation and enabling people to take more responsibility for managing the condition. Benefits of such an approach can include improved knowledge, self-efficacy, health status, and better performance of self-management behaviours. However, there is only preliminary evidence that people with early-stage dementia can benefit from such interventions.MethodsThis feasibility study involves the development of a self-management group intervention for people with early-stage Alzheimer’s disease, vascular dementia or mixed Alzheimer’s and vascular dementia. This study is a single-site pilot randomised-controlled trial. Forty-two people with early stage dementia, each with a caregiver (family member/friend), will be randomised to either the self-management group intervention or to treatment as usual.The self-management group intervention will involve eight weekly sessions, each lasting 90 minutes, held at a memory clinic in North Wales. All participants will be re-assessed three and six months post-randomisation. This study is intended to supply an early evaluation of the self-management intervention so that a full scale trial may be powered from the best available evidence. It will assess the feasibility of the intervention, the study design and the recruitment strategies. It will estimate the parameters and confidence intervals for the research questions of interest. The primary outcome of interest is the self-efficacy score of the person with dementia at three months post-randomisation. Secondary outcomes for the person with dementia are self-efficacy at six months post-randomisation and cognitive ability, mood and well-being at three and six months post-randomisation. Secondary outcomes for caregivers are their distress and stress at three and six months post-randomisation. The cost-effectiveness of the intervention will also be examined.DiscussionThis study will provide preliminary information about the feasibility, efficacy and cost-effectiveness of a self-management group intervention for people in the early stages of dementia.Trial registrationCurrent Controlled Trials, ISRCTN02023181.
Highlights
The possibility of living well with a long-term condition has been identified as centrally relevant to the needs of people living with dementia
Given the cognitive and functional decline involved in dementia, self-management is most relevant in the early stages, where the emphasis is on managing and living well with the condition [6,7,8]
Offering suitable interventions to people with early-stage dementia could delay admission to residential care and add to the cost-effectiveness of services; in other long-term health conditions, participation in self-management programmes leads to a universal reduction in service costs that remains evident over time [9]
Summary
Design This SMART study involves two phases, following the development and feasibility/piloting phases of the Medical Research Council guidelines for complex interventions [28] and the present paper relates to phase II. Secondary outcome measures completed by people with dementia at baseline, and three and six months post randomisation An important secondary outcome is the GSES score at 6 months post-randomisation, which will allow us to evaluate whether the effects of the self-management group extend into the medium term. Eligible, consenting participants will be randomised to receive either the self-management group intervention or TAU after baseline assessments. A secondary exploratory costeffectiveness analysis will be undertaken using the GSES and ICECAP-O as the measures of effectiveness As this is a pilot trial with a relatively small sample size, the tree-age modelling package will be utilised to map a decision analytic model to inform data collection for the economic evaluation of a future definitive multi-centre study. The research team will have access to the full dataset
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