Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Weighted Blanket Cohort First 15 subjects enrolled have access to sleep with weighted blanket for three nights with monitoring by nurse. Weight of blanket is determined by weight of the patient (10% of patients body weight). |
Other: Weighted Blanket
Weighted blanket will be given to patients based on the patient weight (10% of patients body weight) for three nights while on inpatient unit.
|
| No Intervention: Control Cohort Last 15 subjects enrolled receive treatment as usual while inpatient. |
Outcome Measures
Primary Outcome Measures
- Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change [At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket]
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 [At baseline and within 72 hours of the last use of the weighted blanket.]
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) [At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket]
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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Janette C Leal, M.D, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17-009951