Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dementia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: First 15 subjects enrolled in the study will be given the weighted blanket treatment and the second 15 subjects will be a control cohort.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 60 years and 125 years
- Gender
- Both males and females
Description
The Intervention Group (Cohort 1 - first 15 patients to be enrolled): 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 ...
The Intervention Group (Cohort 1 - first 15 patients to be enrolled): 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 (Cohort 2 - second 15 patients to be enrolled): 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.
Tracking Information
- NCT #
- NCT03643991
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Janette C Leal, M.D Mayo Clinic
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