Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets

NCT03643991 | Completed

• 1 other identifier: 17-009951
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine whether the use of weighted blankets help reduce behavioral and psychological symptoms, including agitation in people with dementia.

Conditions

Dementia

Keywords

Agitation; Dementia; Inpatient

Outcome Measures

Primary Outcomes (1)

• Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change

  Assess the agitation/aggression outcome using numeric scales ranging from 1-5. The sum of the scores is defined as the agitation/aggression outcome and ranges from 14-70, with the lower score being the better outcome.

  At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket

Secondary Outcomes (2)

• The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change

  At baseline and within 72 hours of the last use of the weighted blanket.

• Clinical Global Impressions (CGI)

  At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket

Study Arms (2)

Weighted Blanket Cohort

EXPERIMENTAL

Subjects will receive weighted blanket for three nights with monitoring by nurse. Weight of blanket is determined by weight of the patient (10% of patients body weight).

Other: Weighted Blanket

Control Cohort

NO INTERVENTION

Subjects will receive treatment as usual while inpatient, no blanket.

Interventions

Weighted Blanket OTHER

Weighted blanket will be given to patients based on the patient weight (10% of patients body weight) for three nights while on inpatient unit.

Weighted Blanket Cohort

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted on the inpatient geriatric psychiatry unit, complex interventions unit, internal medicine service and/or admitted hospice GIP
• Documented diagnosis of dementia or suspected major neurocognitive disorder.
• Presence of agitation/aggression symptoms as defined by a minimum aggression score on the Cohen-Mansfield Agitation Inventory Short Version (CMAI): Patients must score 3, 4, or 5 on at least one question related to aggression (items 1-4).
• Have a LAR able to sign the consent on behalf of the patient.

You may not qualify if:

• Severe pain likely to be exacerbated by use of weighted blanket
• Inability to remove blanket;
• Skin burns or open wounds;
• Admitted on 72 hour hold.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Schenzel HA, Palmer AK, Shah NB, Lawson DK, Fischer KM, Lapid MI, DeFoster RE. Weighted Blankets for Agitation in Hospitalized Patients with Dementia: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 26;14:e57264. doi: 10.2196/57264.

  PMID: 40009836 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Dementia; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Maria Lapid, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Enrolled patients will be computer randomized in 1:1 ratio to either the intervention group or the control group.

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 23, 2018
• Study Start: April 11, 2018
• Primary Completion: October 28, 2025
• Study Completion: November 30, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)