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Weighted Blankets for Dementia-Related Agitation

N/A

Waitlist Available

Led By Janette C Leal, M.D

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients admitted on the inpatient geriatric psychiatry unit, complex interventions unit, internal medicine service and/or admitted hospice GIP

Be older than 18 years old

Must not have

Severe pain likely to be exacerbated by use of weighted blanket

Skin burns or open wounds

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether weighted blankets help reduce agitation and aggression in patients with dementia who are hospitalized.

Who is the study for?

This trial is for patients with dementia who are experiencing agitation. They must be in a geriatric psychiatry unit, complex interventions unit, internal medicine service or admitted hospice GIP. A documented diagnosis of dementia and a certain level of aggression on the CMAI scale are required. Patients need someone legally authorized to consent on their behalf.

What is being tested?

The study is testing if using weighted blankets can help calm people with dementia and reduce symptoms like agitation. Participants will use these blankets to see if there's an improvement in their behavior compared to usual care without them.

What are the potential side effects?

Potential side effects may include discomfort due to the weight of the blanket, skin irritation, or worsening pain if already present. However, those with severe pain or skin issues have been excluded from this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am admitted for geriatric psychiatry, complex care, internal medicine, or hospice.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

Using a weighted blanket will likely worsen my severe pain.

Select...

I have skin burns or open wounds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and within 72 hours of the last use of the weighted blanket.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and within 72 hours of the last use of the weighted blanket.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and within 72 hours of the last use of the weighted blanket. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change

Secondary study objectives

Clinical Global Impressions (CGI)

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Weighted Blanket CohortExperimental Treatment1 Intervention

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).

Group II: Control CohortActive Control1 Intervention

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

0 / 3Eligibility criteria met