Doll Therapy in Dementia

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Doll thErapy Compared With Standard Treatment in the Control of Behavioral and Psychologic Symptoms and CaRegIver Burden of dEmentia

Conditions
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Dementia

Intervention / Treatment
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* Other: doll treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥65 years; diagnosis of dementia moderate to severe Clinical Dementia Rating scale (CDR) ≥2; presence of agitation and/or aggressiveness; manual and visual abilities sufficient in order to interact with the doll. Exclusion Criteria: age <65 years; refuse to participate; mild forms of dementia (CDR<2); contraindication for DT as experience of mournful or traumatic events related to parental experience; life expectancy lower than 3 months; negative interaction with the doll.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: doll therapy (DT)<br>doll therapy (emathy dolls) | Other: doll treatment<br>* 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.<br>|
| No Intervention: Standard treatment (ST)<br>standard clinical practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | Change in CBI | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral and psychologic symptoms in dementia; hospital; doll therapy; non-pharmacological approach; nursing homes