An interventional study of doll treatment in Dementia, sponsored by Centre Hospitalier Universitaire Vaudois. Completed at 1 site in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-06-10.
Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Treatment
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 104 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
doll therapy (emathy dolls)
Other: doll treatment
standard clinical practice
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.
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
Time frame: 10-45-90 days
Change in professional caregivers burden measured by the Greutzner scale
change in professional caregiver burden
Time frame: 10-45-90 days
Incidence of delirium measured by the Confusion assessment Method (CAM) scale
change in delirium incidence
Time frame: 45 and 90 days
Change in caregiver burden measured by the caregiver Burden Inventory (CBI)
Change in CBI
Time frame: 28 days
Plan to share: No
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Vaudois