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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.
The Intervention Group
Control Group:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weighted Blanket Cohort | Experimental | 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). |
|
| Control Cohort | No Intervention | Subjects will receive treatment as usual while inpatient, no blanket. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weighted Blanket | Other | Weighted blanket will be given to patients based on the patient weight (10% of patients body weight) for three nights while on inpatient unit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Lapid, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40009836 | Derived | Schenzel HA, Palmer AK, Shah NB, Lawson DK, Fischer KM, Lapid MI, DeFoster RE. Weighted Blankets for Agitation in Hospitalized Patients with Dementia: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 26;14:e57264. doi: 10.2196/57264. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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Enrolled patients will be computer randomized in 1:1 ratio to either the intervention group or the control group.
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| At baseline and within 72 hours of the last use of the weighted blanket. |
| 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. | At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |