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Clinical Trial 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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03643991
Study type Interventional
Source Mayo Clinic
Contact
Status Enrolling by invitation
Phase N/A
Start date April 11, 2018
Completion date March 2026

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