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Doll Therapy in Dementia (DESCRIBE)

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
doll treatment
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring behavioral and psychologic symptoms in dementia; hospital; doll therapy; non-pharmacological approach; nursing homes

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • città della salute e della Scienza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

doll therapy (DT)

Standard treatment (ST)

Arm Description

doll therapy (emathy dolls)

standard clinical practice

Outcomes

Primary Outcome Measures

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
Change in professional caregivers burden measured by the Greutzner scale
change in professional caregiver burden

Secondary Outcome Measures

Incidence of delirium measured by the Confusion assessment Method (CAM) scale
change in delirium incidence
Change in caregiver burden measured by the caregiver Burden Inventory (CBI)
Change in CBI

Full Information

First Posted
June 2, 2021
Last Updated
June 8, 2021
Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
Azienda Ospedaliera Città della Salute e della Scienza di Torino
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1. Study Identification

Unique Protocol Identification Number
NCT04920591
Brief Title
Doll Therapy in Dementia
Acronym
DESCRIBE
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
Azienda Ospedaliera Città della Salute e della Scienza di Torino

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
behavioral and psychologic symptoms in dementia; hospital; doll therapy; non-pharmacological approach; nursing homes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
doll therapy (DT)
Arm Type
Experimental
Arm Description
doll therapy (emathy dolls)
Arm Title
Standard treatment (ST)
Arm Type
No Intervention
Arm Description
standard clinical practice
Intervention Type
Other
Intervention Name(s)
doll treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of behavioral and psychologic symptoms in dementia measured by Neuropsychiatric Inventory (NPI) scale and by the A.Di.Co scale
Description
Change in NPI and A.Di.Co scales
Time Frame
10-45-90 days
Title
Change in professional caregivers burden measured by the Greutzner scale
Description
change in professional caregiver burden
Time Frame
10-45-90 days
Secondary Outcome Measure Information:
Title
Incidence of delirium measured by the Confusion assessment Method (CAM) scale
Description
change in delirium incidence
Time Frame
45 and 90 days
Title
Change in caregiver burden measured by the caregiver Burden Inventory (CBI)
Description
Change in CBI
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
città della salute e della Scienza
City
Torino
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34641791
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.
Results Reference
derived

Learn more about this trial

Doll Therapy in Dementia

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