Doll Therapy in Dementia

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Other: doll treatment

• Registration Number: NCT04920591
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-10-31
• Study Completion: 2020-01-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-08
• Last Update Submitted: 2021-06-08
• Study First Posted: 2021-06-10
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
doll therapy (DT)	doll treatment	doll therapy (emathy dolls)

Primary Outcome Measures

Name	Time	Method
Incidence of behavioral and psychologic symptoms in dementia measured by Neuropsychiatric Inventory (NPI) scale and by the A.Di.Co scale	10-45-90 days	Change in NPI and A.Di.Co scales
Change in professional caregivers burden measured by the Greutzner scale	10-45-90 days	change in professional caregiver burden

Secondary Outcome Measures

Name	Time	Method
Incidence of delirium measured by the Confusion assessment Method (CAM) scale	45 and 90 days	change in delirium incidence
Change in caregiver burden measured by the caregiver Burden Inventory (CBI)	28 days	Change in CBI

Trial Locations

Locations (1)

città della salute e della Scienza; 🇮🇹 Torino, Italy