Clinical trial NCT04920591: Doll Therapy in Dementia
Official title: Efficacy of Doll thErapy Compared With Standard Treatment in the Control of Behavioral and Psychologic Symptoms and CaRegIver Burden of dEmentia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: behavioral and psychologic symptoms in dementia; hospital; doll therapy; non-pharmacological approach; nursing homes
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: A.O.U. Città della Salute e della Scienza
First posted: 2021-06-10
Enrollment: 104
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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;
* negative interaction with the doll.

Primary outcomes:
measure: Incidence of behavioral and psychologic symptoms in dementia measured by Neuropsychiatric Inventory (NPI) scale and by the A.Di.Co scale
timeFrame: 10-45-90 days
measure: Change in professional caregivers burden measured by the Greutzner scale
timeFrame: 10-45-90 days
Secondary outcomes:
measure: Incidence of delirium measured by the Confusion assessment Method (CAM) scale
timeFrame: 45 and 90 days
measure: Change in caregiver burden measured by the caregiver Burden Inventory (CBI)
timeFrame: 28 days
Other outcomes:
Locations:
city: Torino
country: Italy
facility: città della salute e della Scienza
Study officials:
References:
citation: 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.