The Journeying through Dementia psychosocial intervention versus usual care study: a two-arm, phase 3, superiority randomised controlled trial

Background There is an urgent clinical need for evidence based psychosocial interventions for people with mild dementia. We aimed to determine clinical and cost-effectiveness of Journeying through Dementia (JtD), an intervention designed to promote wellbeing and independence in people with mild dementia. Methods We conducted a phase 3, two-arm parallel group, superiority, individually randomised controlled trial. Thirteen NHS sites across England recruited community-dwelling people with mild dementia and Mini-Mental State Examination score of ≥18. Centralised randomisation (1:1) was conducted for participants to receive JtD plus usual care or usual care (control), stratified by site. The JtD Intervention comprised 12 group and four one-to-one sessions, delivered in the community at each site. The primary endpoint was Dementia Related Quality of Life (DEMQOL), eight-months postrandomisation. Only outcome assessors were blinded. Analysis was by intention-to-treat. Costeffectiveness analysis reported cost per quality adjusted life year (QALY) from a UK NHS and social care perspective. Findings In total 480 people were randomised to intervention (241) or control (239) arms. Intervention adherence was very good. Mean DEMQOL scores at eight months were intervention arm 93·3 (SD 13·0, n=191) and control 91·9 (SD 14·6, n=197). Difference in means was 0·9 (95% CI -1·2 to 3·0) after adjustment for covariates, lower than that identified as clinically meaningful. Incremental cost per QALY ranged from £88K to -£205K, indicating that JtD was not cost-effective. Unrelated serious adverse events were experienced by 17% (40/241) of intervention and 15% (35/239) of control participants. Interpretation In common with other recently reported studies the JtD intervention was not provenly effective. However, this complex trial successfully recruited and retained people with dementia without necessarily involving carers, and people with dementia they were actively involved as participants and study advisors throughout. Further research into methods of measuring small, meaningful changes in this population is needed. Questions remain regarding how services can match the complex, diverse and individual needs of people with mild dementia, and how interventions to meet such needs can be delivered at scale