Doll Therapy in Dementia

N/ACompletedNCT04920591

Centre Hospitalier Universitaire Vaudois104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

104

Conditions

Dementia

Interventions

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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