Weighted Blankets for Agitation in Hospitalized Patients with Dementia: Protocol for a Randomized Controlled Trial.

Abstract

Background: There are limited therapies approved for the treatment of aggression and agitation in patients with dementia. While antipsychotics and benzodiazepines are commonly used, these medications have been associated with significant side effects and US Food and Drug Administration (FDA) boxed warnings. Weighted blankets have been associated with decreased anxiety and improved sleep. Weighted blankets are potentially a nonpharmacologic option to reduce agitation in hospitalized patients with dementia.

Objective: The aim of this study is to investigate the effect of weighted blankets on aggression and agitation in hospitalized patients with dementia.

Methods: A pilot study will be conducted on a total of 30 hospitalized patients with a documented clinical diagnosis of dementia and ongoing agitated behaviors admitted to a medicine or psychiatry service. Patients will be randomly allocated to receive either a weighted blanket for 3 nights or continued usual care. The primary outcome is the change in the observational version of the Cohen-Mansfield Agitation Inventory (CMAI-O) over the course of the 3-night study period. The secondary outcomes are changes in Edmonton Symptom Assessment System Revised (ESAS-r) and Clinical Global Impression (CGI) scores, hours of sleep, use of antipsychotics and benzodiazepines, and incidence of delirium. Identical study assessments will be completed for both the usual care and the weighted blanket study groups. At 5 study time points (baseline, postnight 1, postnight 2, postnight 3, and a final assessment 48-72 h after the last use of the weighted blanket), patients will be assessed with the CMAI-O, ESAS-r, and CGI tools. All assessments will be completed by the bedside nurse or patient care assistant caring for the patient each day. Within 2 to 4 weeks post discharge from the hospital, study coordinators will contact the patient's legally authorized representative (LAR) to assess for continued use of the weighted blanket.

Results: Enrollment of participants began on April 23, 2023. As of November 2024, a total of 24 participants have been enrolled in the study. Baseline characteristics of enrolled participants will be analyzed and reported upon completion of enrollment. We anticipate completing data collection by March 2026.

Conclusions: The study will determine the effect of weighted blankets on agitation in hospitalized patients with dementia. Insights into the effect of weighted blankets on sleep will also be gained. The results of this study will be relevant in the setting of increasing numbers of older adults with dementia exhibiting agitation, leading to increased hospitalizations, caregiver burden, and health care costs.

Trial registration: ClinicalTrials.gov NCT03643991; http://clinicaltrials.gov/ct2/show/NCT03643991.

International registered report identifier (irrid): DERR1-10.2196/57264.