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| Name | Class |
|---|---|
| A.O.U. Città della Salute e della Scienza | OTHER |
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Behavioral and psychologic symptoms in dementia (BPSD) are frequent and represent a burden for patients and caregivers, the use of a first line non-pharmacologic approach is highly recommended. DESCRIBE is a randomized controlled trial on the effect of doll therapy (DT) on BPSD in different clinical settings.
The investigators will enroll fifty-two nursing homes residents and 52 acute in-patients with dementia and BPSD. Subjects will be randomized to DT or standard treatment (ST), The investigators will measured agitation, delirium and caregiver burden with standard clinical scales at baseline and during treatment. Nursing home residents will be evaluated after 45 and 90 days of treatment, in-patients will be evaluated at baseline and at hospital discharge. In acute in-patients, a follow-up of 4 weeks after hospital discharge will be carried out in order to evaluate the effect of DT withdrawal.
Primary outcomes will be the reduction of BPSD and the reduction of professional caregiver burden Secondary outcome will be the reduction of delirium and of effect of family caregiver burden.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| doll therapy (DT) | Experimental | doll therapy (emathy dolls) |
|
| Standard treatment (ST) | No Intervention | standard clinical practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doll treatment | Other | The doll used in the study is the "empathy doll"; these dolls are designed to obtain an optimal interaction with patients and to arouse empathy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of behavioral and psychologic symptoms in dementia measured by Neuropsychiatric Inventory (NPI) scale and by the A.Di.Co scale | Change in NPI and A.Di.Co scales | 10-45-90 days |
| Change in professional caregivers burden measured by the Greutzner scale | change in professional caregiver burden | 10-45-90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delirium measured by the Confusion assessment Method (CAM) scale | change in delirium incidence | 45 and 90 days |
| Change in caregiver burden measured by the caregiver Burden Inventory (CBI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| città della salute e della Scienza | Torino | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34641791 | Derived | Santagata F, Massaia M, D'Amelio P. The doll therapy as a first line treatment for behavioral and psychologic symptoms of dementia in nursing homes residents: a randomized, controlled study. BMC Geriatr. 2021 Oct 12;21(1):545. doi: 10.1186/s12877-021-02496-0. |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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Change in CBI
| 28 days |
| D001523 | Mental Disorders |