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.
The Intervention Group 1. Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained. 2. Nursing staff will complete baseline assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r. 3. A weighted blanket, based on admission body weight, will be provided to the patient under nursing supervision. 4. 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. 5. 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: 1. Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained. 2. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Weighted blanket will be given to patients based on the patient weight (10% of patients body weight) for three nights while on inpatient unit.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
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.
Time frame: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket
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.
Time frame: 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.
Time frame: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket
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