TY - JOUR
T1 - A psychosocial goal-setting and manualised support intervention for independence in dementia (NIDUS-Family) versus goal setting and routine care
T2 - a single-masked, phase 3, superiority, randomised controlled trial
AU - Cooper, Claudia
AU - Vickerstaff, Victoria
AU - Barber, Julie
AU - Phillips, Rosemary
AU - Ogden, Margaret
AU - Walters, Kate
AU - Lang, Iain
AU - Rapaport, Penny
AU - Orgeta, Vasiliki
AU - Rockwood, Kenneth
AU - Banks, Sara
AU - Palomo, Marina
AU - Butler, Laurie T.
AU - Lord, Kathyrn
AU - Livingston, Gill
AU - Banerjee, Sube
AU - Manthorpe, Jill
AU - Dow, Briony
AU - Hoe, Juanita
AU - Hunter, Rachael
AU - Samus, Quincy
AU - Budgett, Jessica
N1 - Funding Information:
This work was supported by the Alzheimer's Society (Centre of Excellence grant 330). We thank the NIDUS participants and patient and public involvement group. IL's time is supported in part by the UK National Institute for Health Research Applied Research Collaboration South West Peninsula (NIHR200167). The views expressed in this publication are those of the authors and not necessarily those of the National Institute for Health and Care Research or the UK Department of Health and Social Care.
Funding Information:
This work was supported by the Alzheimer's Society (Centre of Excellence grant 330). We thank the NIDUS participants and patient and public involvement group. IL's time is supported in part by the UK National Institute for Health Research Applied Research Collaboration South West Peninsula (NIHR200167). The views expressed in this publication are those of the authors and not necessarily those of the National Institute for Health and Care Research or the UK Department of Health and Social Care.
Publisher Copyright:
© 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
PY - 2024/2
Y1 - 2024/2
N2 - Background: Although national guidelines recommend that everyone with dementia receives personalised post-diagnostic 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 (72·1%) of whom were excluded. Of 302 eligible dyads, we randomly assigned 98 (32·4%) to the control group and 204 (67·5%) to the intervention group. The mean age of participants with dementia was 79·9 years (SD 8·2), 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 58·7 [SD 13·0; n=163] vs 49·0 [14·1; n=84]; adjusted difference in means 10·23 [95% CI 5·75–14·71]; p<0·001). 31 (15·2%) participants in the intervention group and 14 (14·3%) 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. Funding: UK Alzheimer's Society.
AB - Background: Although national guidelines recommend that everyone with dementia receives personalised post-diagnostic 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 (72·1%) of whom were excluded. Of 302 eligible dyads, we randomly assigned 98 (32·4%) to the control group and 204 (67·5%) to the intervention group. The mean age of participants with dementia was 79·9 years (SD 8·2), 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 58·7 [SD 13·0; n=163] vs 49·0 [14·1; n=84]; adjusted difference in means 10·23 [95% CI 5·75–14·71]; p<0·001). 31 (15·2%) participants in the intervention group and 14 (14·3%) 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. Funding: UK Alzheimer's Society.
UR - http://www.scopus.com/inward/record.url?scp=85183952509&partnerID=8YFLogxK
U2 - 10.1016/S2666-7568(23)00262-3
DO - 10.1016/S2666-7568(23)00262-3
M3 - Article
C2 - 38310894
AN - SCOPUS:85183952509
SN - 2666-7568
VL - 5
SP - e141-e151
JO - The Lancet Healthy Longevity
JF - The Lancet Healthy Longevity
IS - 2
ER -