The Effect of Risperidone on Nursing Burden Associated with Caring for Patients with Dementia
Funding provided by Janssen Medical Affairs, L.L.C. Drs. Lori Frank and Leah Kleinman and Ms. Gabrielle Ciesla completed this work under paid contract to their employer from Janssen Medical Affairs, L.L.C. Dr. Marcia Rupnow is an employee of Janssen Medical Affairs, L.L.C. Dr. Henry Brodaty served as a consultant to Janssen Medical Affairs, L.L.C., has received grant/research support and honoraria from Janssen, and serves on the speakers/advisory board for Janssen.
Abstract
Objectives: To compare risperidone treatment with placebo for the burden to nursing staff of older nursing-home residents with dementia.
Design: Randomized, double-blind, placebo-controlled trial.
Setting: Long-term care institutions in Australia and New Zealand.
Participants: Two hundred seventy-nine residents had evaluable data for comparison of oral risperidone with placebo treatment at 4 weeks, 8 weeks, and endpoint across the 12-week trial.
Measurements: The Modified Nursing Care Assessment Scale (M-NCAS) is a 28-item instrument that measures behavior occurrence in patients (patient outcome) and difficulty of those behaviors for nursing staff as rated by nurse carers (nurse outcome). Treatment groups were compared via analysis of covariance (ANCOVA). To aid score interpretation, M-NCAS effect sizes were examined by response category, with response defined as subjects with mean Cohen-Mansfield Agitation Inventory total aggression subscale score change of 4 points or greater, a clinical outcome for patients.
Results: Between-group ANCOVAs showed statistically significant reductions in nurse-rated M-NCAS scores from baseline to endpoint for the patients randomized to risperidone relative to placebo (P<.05). Effects were evident at 4 weeks and maintained over time. Effect sizes were moderate to large for responders and near zero for nonresponders.
Conclusion: Risperidone treatment was associated with an early and sustained reduction in nursing staff burden as measured using the M-NCAS compared with placebo treatment for older nursing home residents with dementia.
