A New psychosocial goal-setting and manualised support intervention for Independence in Dementia (NIDUS-Family) versus goal-setting and routine care: longer term outcomes of a single-masked, phase 3, superiority Randomised Controlled Trial

BackgroundNIDUS-Family is a manualised intervention, deliverable by non-clinical facilitators which is clinically (on Goal Attainment Scaling - GAS) and cost effective over 12 months. AimsTo evaluate whether goal setting plus NIDUS-Family was more effective than control (goal-setting and routine care) in supporting dyads (family carers and care recipients with dementia) attainment of personalised goals at 18 and 24 months; and participant perceived goal relevance over 24-months. MethodA single-masked, randomised controlled trial recruiting dyads from community settings. Randomisation used a 2:1 ratio (intervention: control). NIDUS-Family is tailored to goals dyads set by selecting modules involving behavioural interventions, carer support, psychoeducation, communication, enablement and environmental adaptations. It involved 6-8 video-call/telephone sessions over 6 months, then follow-ups 2-3 monthly for 6 months. Our primary outcome was GAS at 18 and 24 months. Secondary outcomes assessed care recipient functioning, quality of life, time until care home admission or death, carer anxiety and depression. Primary analysis, a mixed-effects model, accounted for randomization group, study site, time, intervention-arm facilitator and repeated measurements. ResultsIn 2020-21, 204 participants were randomised to intervention and 98 to control. 164 (54.3%) and 141(46.7%) dyads completed 18 and 24-month outcomes respectively. In the primary analysis, including 277 participants contributing 6-, 12-, 18- or 24-month outcomes, adjusted GAS mean differences (intervention-control) at 18 and 24-months were 11.78 (95% CI (Confidence Interval) 6.64,16.93) and 8.67 (3.31,14.02). Secondary outcome comparisons were not significant. The hazard ratio for dying or care home admission was 0.80 (0.45,1.42) (intervention v control); and 0.87 (0.41,1.82) and 0.59 (0.26,1.33) for death and care home admission respectively. Of baseline GAS goals, carers considered 436 (78.0%) relevant at 18 and 383 (78.5%) at 24 months. ConclusionsThe NIDUS-Family intervention improved personalised attainment of GAS goals that remained relevant for most dyads, over two years. Trial Registration Number: ISRCTN11425138.