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



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:60 - Any
Updated:11/24/2018
Start Date:April 11, 2018
End Date:June 30, 2021
Contact:Monica Walton
Email:walton.monica@mayo.edu
Phone:507-422-0689

Use our guide to learn which trials are right for you!

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

Hospitalized patients with dementia and aggression and/or agitation will be given a weighted
blanket to see if there are significant reductions in agitated and aggressive behaviors
compared to treatment as usual.

The Intervention Group (Cohort 1 - first 15 patients to be enrolled):

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 (Cohort 2 - second 15 patients to be enrolled):

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.

Inclusion Criteria:

1. Patients admitted on the inpatient geriatric psychiatry unit, age 60 years and older.

2. Diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition (DSM-IV) criteria.

3. Presence of agitation/aggression symptoms as defined by a minimum aggression score on
the Cohen-Mansfield Agitation Inventory Short Version (CMAI): a score ≥ 4 on at least
one aggressive item.

Exclusion Criteria:

1. Inability to remove blanket;

2. Severe pain exacerbated by use of weighted blanket;

3. Skin burns or open wounds;

4. Allergy to blanket material.

5. Admitted on 72 hour hold.
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Janette C Leal
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials