Doll Therapy in Dementia (DESCRIBE)

Vaud University Hospital Center

Status

Completed

Conditions

Dementia

Treatments

Other: doll treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04920591

0098548

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.