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

Dementia Clinical Trial

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

Status Enrolling by invitation

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. ;

Related Conditions & MeSH terms

• Dementia
• Psychomotor Agitation

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