Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients

Study Overview
=================
Brief Summary
-----------------
Summary. Behavioral and psychological symptoms of dementia (BPSD) represents a huge emotional stress and an important burden for the patients and the caregivers severely reducing their quality of life. BPSD worsen during hospitalization and require the administration of psychotropic drugs that are often insufficient to control the symptoms, and may cause severe adverse events. The investigators propose the use of empathy dolls in order to reduce BPSD and in particular agitation and aggressiveness in acute geriatric in-patients affected by moderate to severe forms of dementia. The use of doll therapy in the clinical routine will allow to reduce the use of psychotropic drugs, shorten hospitalization, reduce professional and family caregiver burden improving patients' and families' quality of life.

Official Title
-----------------
Efficacy of Doll Therapy in the Control of Behavioral and psychologIcal Symptoms of Dementia in Acute Geriatric Inpatients: the AGITATE Study.

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Other: doll therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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; infectious diseases requiring isolation; negative interaction with the doll, presence of delirium.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized controlled open label trial with two parallel arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: doll therapy<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 | Other: doll therapy<br>* empathy dolls<br>|
| Other: non anthropomorphic object<br>non- anthropomorphic soft object | Other: doll therapy<br>* empathy dolls<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| agitation and aggressiveness within hospital | measured by Pittsburgh Agitation Scale (PAS). the score ranges between 0 to 16 on the PAS the higher score means the higher agitation | baseline and hospital discharge discharge (up to one week) | 
| behavioural and psychological symptoms of dementia | Neuro Psychiatic Inventory (NPI). The NPI total score ranges from 0 to 144, higher scores means more severe and frequent behavioural and psycological symptoms of dementia | baseline, discharge (up to one week) | 
| agitation and aggressiveness outside hospital | Cohen Mansfield Inventory scale (CMAI). the score ranges betwen 0 and 203, with higher scores indicating more agitation | baseline, 1 and 4 weeks after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of delirium | measured by the Confusion Assessment Method (CAM) scale. For a diagnosis of delirium by CAM, the patient must display: Presence of acute onset and fluctuating discourse AND Inattention AND EITHER Disorganized thinking OR Altered level of consciousness | every day during hospital stay (up to one week) | 
| patients' quality of life | by the use of the AD-5D Dementia Utility Instrument, the scales scores between -1 to 1, the highest score indicate the better quality of life | baseline and 4 weeks after discharge | 
| family caregivers' quality of life | by the EuroQoL 5-Dimensions 5 level versions. the scale scores from 5 to 25 the highest the score the lowest the quality of life | baseline and 4 weeks after discharge | 
| professional caregiver burden | Staff Stress Measure Dementia Care (SSMDC). The scale comprised the following 27 items producing a five-factor solution: Frustrated empathy; difficulties understanding and interpreting; balancing competing needs; balancing emotional involvement; and lack of recognition. | baseline and at hospital discharge (up to one week) | 
| family caregiver burden | Caregiver Burden Inventory (CBI) scale. The Caregiver Burden Inventory comprises 24 closed questions divided into five dimensions: time-dependence, developmental, physical, social and emotional burden. There are five items in each dimension except for physical burden, which has four items dedicated to. Each item is given a score between 0 (not at all descriptive) and 4 (very descriptive), where higher scores indicate greater caregiver burden; there are no cut-off points for classifying burden. Therefore, total scores for factors one, two, four and five can range from zero to 20. An equivalent score for physical burden can be obtained by multiplying the sum of items in this dimension by 1.25 | baseline and 4 weeks after discharge |