A psychosocial goal-setting and manualised support intervention for independence in dementia (NIDUS-Family) versus goal setting and routine care: a single-masked, phase 3, superiority, randomised controlled trial

Background Although national guidelines recommend that everyone with dementia receives personalised postdiagnostic support, few do. Unlike previous interventions that improved personalised outcomes in people with dementia, the NIDUS-Family intervention is fully manualised and deliverable by trained and supervised, non-clinical facilitators. We aimed to investigate the effectiveness of home-based goal setting plus NIDUS-Family in supporting the attainment of personalised goals set by people with dementia and their carers. Methods We did a two-arm, single-masked, multi-site, randomised, clinical trial recruiting patient-carer dyads from community settings. We randomly assigned dyads to either home-based goal setting plus NIDUS-Family or goal setting and routine care (control). Randomisation was blocked and stratified by site (2:1; intervention to control), with allocations assigned via a remote web-based system. NIDUS-Family is tailored to goals set by dyads by selecting modules involving behavioural interventions, carer support, psychoeducation, communication and coping skills, enablement, and environmental adaptations. The intervention involved six to eight video-call or telephone sessions (or in person when COVID-19-related restrictions allowed) over 6 months, then telephone follow-ups every 2-3 months for 6 months. The primary outcome was carer-rated goal attainment scaling (GAS) score at 12 months. Analyses were done by intention to treat. This trial is registered with the ISRCTN registry, ISRCTN11425138. Findings Between April 30, 2020, and May 9, 2021, we assessed 1083 potential dyads for eligibility, 781 (72 center dot 1%) of whom were excluded. Of 302 eligible dyads, we randomly assigned 98 (32 center dot 4%) to the control group and 204 (67 center dot 5%) to the intervention group. The mean age of participants with dementia was 79 center dot 9 years (SD 8 center dot 2), 169 (56%) were women, and 133 (44%) were men. 247 (82%) dyads completed the primary outcome, which favoured the intervention (mean GAS score at 12 months 58 center dot 7 [SD 13 center dot 0; n=163] vs 49 center dot 0 [14 center dot 1; n=84]; adjusted difference in means 10 center dot 23 [95% CI 5 center dot 75-14 center dot 71]; p<0 center dot 001). 31 (15 ¢er dot 2%) participants in the intervention group and 14 (14 center dot 3%) in the control group experienced serious adverse events. Interpretation To our knowledge, NIDUS-Family is the first readily scalable intervention for people with dementia and their family carers that improves attainment of personalised goals. We therefore recommend that it be implemented in health and care services.