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Completed

NCT Number: NCT04920591

Doll Therapy in 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.

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Key information

Conditions

Dementia Behavior Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

città della salute e della Scienza

Torino, 10126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of behavioral and psychologic symptoms in dementia measured by Neuropsychiatric Inventory (NPI) scale and by the A.Di.Co scale

    Time frame: 10-45-90 days

    Change in NPI and A.Di.Co scales

  2. Change in professional caregivers burden measured by the Greutzner scale

    Time frame: 10-45-90 days

    change in professional caregiver burden

Secondary outcomes

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

    Time frame: 45 and 90 days

    change in delirium incidence

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

    Time frame: 28 days

    Change in CBI

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Collaborators

  • A.O.U. Città della Salute e della Scienza

Registry information

Official study title

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

Acronym: DESCRIBE

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 10, 2021
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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