Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients

Dementia Clinical Trial

— AGITATE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05691569
• Other study ID #: agitate
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: May 31, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• doll therapy
empathy dolls

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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