Doll Therapy in Dementia

Dementia Clinical Trial

— DESCRIBE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04920591
• Other study ID #: 0098548
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2021
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 31, 2020
• Est. primary completion date: October 31, 2019
• 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;
• negative interaction with the doll.

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• doll treatment
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.

Locations

Country	Name	City	State
Italy	città della salute e della Scienza	Torino

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in professional caregivers burden measured by the Greutzner scale	change in professional caregiver burden	10-45-90 days
Secondary	Incidence of delirium measured by the Confusion assessment Method (CAM) scale	change in delirium incidence	45 and 90 days
Secondary	Change in caregiver burden measured by the caregiver Burden Inventory (CBI)	Change in CBI	28 days