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

Study Overview
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Brief Summary
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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.

Detailed Description
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The Intervention Group Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained. Nursing staff will complete baseline assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r. A weighted blanket, based on admission body weight, will be provided to the patient under nursing supervision. For 3 consecutive days after each use of weighted blanket, nursing staff will complete morning assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r. At the end of the intervention, nursing staff will complete post-intervention assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r. Control Group: Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained. The study team will recruit a group of patients with similar characteristics as described in the inclusion criteria; however, the patient will not receive the weighted blanket, but undergo the same assessments as described in 1-5 (above) and in the Schedule of Assessments.

Official Title
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Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets: A Pilot Study

Conditions
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Dementia

Intervention / Treatment
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* Other: Weighted Blanket


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Enrolled patients will be computer randomized in 1:1 ratio to either the intervention group or the control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weighted Blanket Cohort<br>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<br>* Weighted blanket will be given to patients based on the patient weight (10% of patients body weight) for three nights while on inpatient unit.<br>|
| No Intervention: Control Cohort<br>Subjects will receive treatment as usual while inpatient, no blanket. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change | Assessment of symptoms in palliative patients using numeric analog scales ranging from 0 to 10 to assess levels of pain, tiredness, drowsiness, nausea, appetite, shortness of breath, depression, anxiety, and well-being. The sum of the scores for all symptoms is defined as the symptom distress score. The range of the sum is 0-100, with a lower score indicating a better outcome. The ESAS-r is a validated tool and publicly available for use. | At baseline and within 72 hours of the last use of the weighted blanket. | 
| Clinical Global Impressions (CGI) | Aggression/Agitation as a measure of the global clinical outcome using a numeric scale ranging from 1-7, with a lower score indicating a better outcome. | At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Agitation, Dementia, Inpatient