Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets
Primary Purpose
Dementia
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weighted Blanket
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring Agitation, Dementia, Inpatient
Eligibility Criteria
Inclusion Criteria:
- Patients admitted on the inpatient geriatric psychiatry unit, age 60 years and older.
- Diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
- 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:
- Inability to remove blanket;
- Severe pain exacerbated by use of weighted blanket;
- Skin burns or open wounds;
- Allergy to blanket material.
- Admitted on 72 hour hold.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Weighted Blanket Cohort
Control Cohort
Arm Description
Subjects will receive weighted blanket for three nights with monitoring by nurse. Weight of blanket is determined by weight of the patient (10% of patients body weight).
Subjects will receive treatment as usual while inpatient, no blanket.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03643991
Brief Title
Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets
Official Title
Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
The Intervention Group
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Agitation, Dementia, Inpatient
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Enrolled patients will be computer randomized in 1:1 ratio to either the intervention group or the control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Weighted Blanket Cohort
Arm Type
Experimental
Arm Description
Subjects will receive weighted blanket for three nights with monitoring by nurse. Weight of blanket is determined by weight of the patient (10% of patients body weight).
Arm Title
Control Cohort
Arm Type
No Intervention
Arm Description
Subjects will receive treatment as usual while inpatient, no blanket.
Intervention Type
Other
Intervention Name(s)
Weighted Blanket
Intervention Description
Weighted blanket will be given to patients based on the patient weight (10% of patients body weight) for three nights while on inpatient unit.
Primary Outcome Measure Information:
Title
Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change
Description
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
Secondary Outcome Measure Information:
Title
The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change
Description
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.
Title
Clinical Global Impressions (CGI)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients admitted on the inpatient geriatric psychiatry unit, complex interventions unit, internal medicine service and/or admitted hospice GIP
Documented diagnosis of dementia or suspected major neurocognitive disorder.
Presence of agitation/aggression symptoms as defined by a minimum aggression score on the Cohen-Mansfield Agitation Inventory Short Version (CMAI): Patients must score 3, 4, or 5 on at least one question related to aggression (items 1-4).
Have a LAR able to sign the consent on behalf of the patient.
Exclusion Criteria:
Inability to remove blanket;
Skin burns or open wounds;
Admitted on 72 hour hold.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Lapid, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets
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