The clinical and cost-effectiveness of improving sleep via carer delivered strategies in people with dementia: the DREAMS START parallel multi-centre RCT.

BACKGROUND: Sleep disturbances are common and distressing for people with dementia and their family carers and can lead to carers having interrupted sleep, low mood and care breakdown. Medication can have harmful side effects and is generally ineffective. Non-pharmacological interventions should be first-line treatments, yet until now there have not been effective treatments. OBJECTIVES: To establish whether Dementia RElAted Manual for Sleep; STrAtegies for RelaTives (DREAMS START), a multicomponent intervention, reduced sleep disturbance in people with dementia living at home at 8 months compared with National Health Service treatment (treatment as usual). DESIGN AND METHODS: We conducted a two-arm, multicentre, parallel-arm, superiority randomised controlled trial with masked outcome assessment. Participants were randomised (1 : 1 ratio) to DREAMS START intervention plus treatment as usual or treatment as usual alone. Analyses were intention to treat. We conducted a mixed-method process evaluation with additional substudies: one exploring how United Kingdom-based South Asians experience sleep disturbance and dementia, and one exploring the interaction of sleep, dementia and long-term conditions. SETTINGS AND PARTICIPANTS: We recruited dyads of people with dementia and sleep disturbance living at home and family carers from 12 National Health Service trusts and the Join Dementia Research service in England. INTERVENTIONS: DREAMS START is a six-session, multicomponent, manualised intervention delivered to family carers of people with dementia who implement strategies to improve their relatives' sleep. It is delivered face to face or remotely by non-clinically trained graduates weekly or fortnightly and incorporates information about sleep and dementia, promotes de-arousal at night, adaptive stimulus control (e.g. bedtime routine maintenance), daytime behavioural activation, increasing access to light, improving carer sleep and making a tailored action plan. MAIN OUTCOME MEASURES: The primary outcome was sleep disturbance measured using the Sleep Disorders Inventory at 8 months. RESULTS: Between February 2021 and March 2023, 377 dyads were randomly assigned, 189 to treatment as usual and 188 to DREAMS START plus treatment as usual. Mean age of participants with dementia was 79.4 years (standard deviation 9.0), and 206 (55%) were women. Mean Sleep Disorders Inventory score at 8 months was lower in the intervention versus treatment-as-usual arm [15.16 (standard deviation 12.77), n = 159, vs. 20.34 (16.67), n = 163]; adjusted difference in means [-4.70 (95% confidence interval -7.65 to -1.74); p = 0.002]. Seventeen (9%) people with dementia in the intervention and 17 (9%) in the control arm died during the trial; deaths were unrelated to the intervention. The mean incremental difference in health and care costs incorporating wider costs was £116 less per dyad (95% confidence interval -£5769 to £5536) for DREAMS START compared to treatment as usual. There was a 78% probability that DREAMS START is cost-effective compared to treatment as usual at a £20,000 decision threshold with no significant difference in quality of life. CONCLUSION: DREAMS START plus treatment as usual is clinically effective in reducing sleep disturbance in people living at home with dementia at 8 months, demonstrating sustained effectiveness beyond intervention delivery. DREAMS START is likely to be cost-effective, and delivery by non-clinically trained graduates increases potential for National Health Service implementation at scale. LIMITATIONS: We relied upon family carers' proxy and self-reported outcomes, with intervention participants potentially more invested and optimistic, increasing risk of bias. Additionally, based on our feasibility randomised controlled trial, we did not include actigraphy or another direct measure of sleep and activity. FUTURE WORK: Studies should explore the longer-term effect of DREAMS START (we are following up participants at 2 years), and there should be an implementation study considering delivery and scaling up DREAMS START in real-world healthcare settings. FUNDING: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR128761.