DOI: 10.5061/dryad.75373
title: Data from: Impact of person-centred care training and person-centred activities on quality of life, agitation, and antipsychotic use in people with dementia living in nursing homes: a cluster-randomised controlled trial

description: Background: Agitation is a common, challenging symptom affecting large
 numbers of people with dementia and impacting on quality of life (QoL).
 There is an urgent need for evidence-based, cost-effective psychosocial
 interventions to improve these outcomes, particularly in the absence of
 safe, effective pharmacological therapies. This study aimed evaluate the
 efficacy of a person-centered care and psychosocial intervention (WHELD)
 on QoL, agitation and antipsychotic use in people with dementia living in
 nursing homes, and to determine its cost. Methods and Findings: This was a
 randomized controlled cluster trial conducted between 1st January 2013 and
 30th September 2015 which compared the WHELD intervention with treatment
 as usual in people with dementia living in 69 UK nursing homes, using an
 intention to treat analysis. All nursing homes allocated to the
 intervention received staff training in person-centered care (PCC), social
 interaction (SoI) and education regarding antipsychotic medications (AM)
 followed by ongoing delivery through a care staff champion model. Primary
 outcome measure was QoL (DEMQOL-proxy). Secondary outcomes were agitation
 (Cohen Mansfield Agitation Inventory), neuropsychiatric symptoms (NPI),
 antipsychotic use, global deterioration (CDR), mood (Cornell Scale for
 Depression in Dementia CSSD), unmet needs (Camberwell Assessment of Need
 in the Elderly CANE), mortality, quality of interactions (Quality of
 Interactions Scale –QUIS), pain (Abbey) and cost. Costs were calculated
 using cost function figures compared with usual costs. 847 people were
 randomized to WHELD or treatment as usual, of whom 553 completed the
 nine-month RCT. The intervention conferred a statistically significant
 improvement in QoL (DEMQOL proxy z score 2.82, p=0.0042, Mean Difference
 2.54 SEM 0.88, 95% Confidence Intervals (CI) 0.81, 4.28, Cohen’s D Effect
 Size 0.24). There were also statistically significant benefits in
 agitation (CMAI Z score 2.68 p=0.0076, Mean Difference 4.27 SEM 1.59, 95%
 CI -7.39, -1.15, Cohen’s D 0.23) and overall neuropsychiatric symptoms (Z
 score 3.52 Mean Difference 4.55 SEM 1.28 p=0.00045, 95% CI -7.07,-2.02,
 Effect Size 0.30). Benefits were greatest in people with
 moderate-moderately severe dementia. There was a statistically significant
 benefit in positive care interactions as measured by QUIS (19.7% increase,
 SEM 8.94, 95% CI 2.12, 37.16, Cohen’s D 0.55, P=0.03). There were no
 statistically significant differences between WHELD and treatment as usual
 for the other outcomes. A sensitivity analysis using a pre-specified
 imputation model confirmed statistically significant benefits in DEMQOL
 proxy, CMAI and NPI with the WHELD intervention. Antipsychotic drug
 prescribing was at a low stable level in both treatment groups and the
 intervention did not reduce use. The WHELD intervention reduced cost
 compared to treatment as usual, and the benefits achieved were therefore
 associated with a cost saving. The main limitation was that antipsychotic
 review was based on augmenting processes within care homes to trigger
 medical review and did not in this study involve proactive primary care
 education. An additional limitation was the inherent challenge of
 assessing QoL in this patient group. Conclusions: These findings suggest
 that the WHELD intervention confers benefits to QoL, agitation and
 neuropsychiatric symptoms, albeit with relatively small effect sizes, as
 well as cost saving in a model that can readily be implemented into
 nursing homes. Future work should consider how to facilitate
 sustainability of the intervention in these settings. Trial registration:
 ISRCTN Registry ISRCTN62237498
description: WHELDballardetalPLOSMedicine.anonsavSPSS data file of individual participant data