Clinical effectiveness of START (STrAtegies for RelaTives) psychological intervention for family carers and the effects on cost of care for people with dementia: six year follow-up of a randomised controlled trial

Background: START (STrAtegies for RelaTives) intervention reduced depressive and anxiety symptoms of family carers of relatives with dementia at home over two years and was cost-effective. Aims:To assess clinical-effectiveness over six years and impact on costs and care home admission. Methods: We conducted a randomised, parallel group, superiority trial recruiting from 04/11/2009 to 08/06/2011 with six year follow-up. 260 self-identified family carers of people with dementia were randomised 2:1 to START, an eight-session manual-based coping intervention delivered by supervised psychology graduates or Treatment as Usual (TAU). The primary outcome was affective symptoms (hospital anxiety and depression total score; HADS-T). Secondary outcomes included patient and carer service costs, and care home admission. Results: 222 (85.8%) of 173 carers randomised to START and 87 to TAU were included in the 6-year clinical efficacy analysis. Over 72-months, the intervention group compared to TAU was better on HADS-T (adjusted mean difference -2.00 points; 95% confidence interval [CI]: -3.38 to -0.63). Patient-related (START versus TAU respectively: median £5759 versus £16964 in the final year; p =0.07) and carer-related costs (median £377 versus £274 in the final year) were not significantly different between groups nor were group differences in time until care home [Intensity ratio START:TAU = 0.88 (CI: 0.58 to 1.35)]. Conclusions: START is clinically effective and this effect lasts for six years without increasing costs. This is the first intervention with such a long-term clinical and possible economic benefit and has potential to make a difference to individual carers. Declarations of interest: None Word count: 250 Trial Registration: ISCTRN 70017938