Doll Therapy in Dementia

NCT04920591 | Completed

• 1 other identifier: 0098548
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

behavioral and psychologic symptoms in dementia; hospital; doll therapy; non-pharmacological approach; nursing homes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Incidence of delirium measured by the Confusion assessment Method (CAM) scale

  45 and 90 days

• Change in caregiver burden measured by the caregiver Burden Inventory (CBI)

  28 days

Study Arms (2)

doll therapy (DT)

EXPERIMENTAL

doll therapy (emathy dolls)

Other: doll treatment

Standard treatment (ST)

NO INTERVENTION

standard clinical practice

Interventions

doll treatment OTHER

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.

doll therapy (DT)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• A.O.U. Città della Salute e della Scienza: collaborator

Study Sites (1)

città della salute e della Scienza

Torino, 10126, Italy

Location

Related Publications (1)

• 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.

  PMID: 34641791 DERIVED

MeSH Terms

Conditions

Dementia; Behavior

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 10, 2021
• Study Start: January 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: January 31, 2020
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)