Doll Therapy in Dementia (DESCRIBE)

Efficacy of Doll thErapy Compared With Standard Treatment in the Control of Behavioral and Psychologic Symptoms and CaRegIver Burden of dEmentia

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 Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Other: doll treatment

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Torino, Italy, 10126
    • Città della Salute e della Scienza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: doll therapy (DT); doll therapy (emathy dolls)	Other: doll treatment; 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.
No Intervention: Standard treatment (ST); standard clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	10-45-90 days
Change in professional caregivers burden measured by the Greutzner scale	change in professional caregiver burden	10-45-90 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Collaborators: Azienda Ospedaliera Città della Salute e della Scienza di Torino

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: behavioral and psychologic symptoms in dementia; hospital; doll therapy; non-pharmacological approach; nursing homes
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 0098548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No