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Open Access Study protocol

Self-management in early-stage dementia: a pilot randomised controlled trial of the efficacy and cost-effectiveness of a self-management group intervention (the SMART study)

Catherine Quinn1*, Daniel Anderson2, Gill Toms1, Rhiannon Whitaker3, Rhiannon Tudor Edwards4, Carys Jones4 and Linda Clare1

Author Affiliations

1 School of Psychology, Bangor University, Bangor, Gwynedd LL57 2AS, UK

2 The Retreat, Heslington Road, York YO10 5BN, UK

3 North Wales Organisation for Randomised Trials in Health, Y Wern, Bangor University, The Normal Site, Holyhead Road, Gwynedd LL57 2PZ, UK

4 Centre for Health Economics and Medicines Evaluation, Bangor University, Dean Street, Gwynedd LL57 1UT, UK

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Trials 2014, 15:74  doi:10.1186/1745-6215-15-74

Published: 8 March 2014

Abstract

Background

The 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.

Methods

This 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.

Discussion

This 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 registration

Current Controlled Trials, ISRCTN02023181.

Keywords:
Alzheimer’s disease; Vascular dementia; Caregiver; Self-efficacy; Well-being; Support