Dementia
Conditions
Keywords
Agitation, Dementia, Inpatient
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 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.
Interventions
OTHERWeighted 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Enrolled patients will be computer randomized in 1:1 ratio to either the intervention group or the control group.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
* Severe pain likely to be exacerbated by use of weighted blanket * Inability to remove blanket; * Skin burns or open wounds; * Admitted on 72 hour hold.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed