TREATMENT OF SEVERE AGITATION IN NURSING HOMES WITH THE TIME MODEL: RESULTS FROM A CLUSTER-RANDOMIZED CONTROLLED TRIAL

Abstract

A number of clinical trials on caregiver-oriented interventions to treat neuropsychiatric symptoms in dementia has been performed, but the results are contradictory. In a three-month cluster randomized trial including 229 nursing home patients with dementia and moderate to high levels of agitation the participants received either the Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric symptoms (TIME) or a brief education-only intervention. Outcomes were assessed at baseline, eight and twelve weeks. The primary endpoint was between-group difference in change on the agitation item of the Neuropsychiatric Inventory Nursing-home version (NPI-NH) at 8 weeks. Secondary outcomes were between-group differences on agitation at twelve weeks and between-group differences on other neuropsychiatric symptoms, quality of life and use of psychotropic and analgesic drugs. Two-hundred and two patients (88.2%) completed the study. A significant between-group difference was found at both 8 weeks and 12 weeks in favour of patients receiving the TIME intervention. Of the secondary outcomes delusion, depression, disinhibition and quality of life showed significant between-group difference in favour of those receiving the TIME intervention. Among nursing-home patients with dementia and moderate to severe agitation the TIME intervention was superior to an education-only intervention. The results add to the increasing evidence base for the efficacy of non-pharmacological interventions in treating agitation in dementia.