Clinical Trial

Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients

Study acronym: AGITATE
Recruiting
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Summary
Summary. Behavioral and psychological symptoms of dementia (BPSD) represents a huge emotional stress and an important burden for the patients and the caregivers severely reducing their quality of life. BPSD worsen during hospitalization and require the administration of psychotropic drugs that are often insufficient to control the symptoms, and may cause severe adverse events. The investigators propose the use of empathy dolls in order to reduce BPSD and in particular agitation and aggressiveness in acute geriatric in-patients affected by moderate to severe forms of dementia. The use of doll therapy in the clinical routine will allow to reduce the use of psychotropic drugs, shorten hospitalization, reduce professional and family caregiver burden improving patients' and families' quality of life.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-01-19; most recent amendment 2025-04-07.
Status change: Not Yet Recruiting → Recruiting 2025-04-07
Trial Details
NCT Number NCT05691569
Lead Sponsor Centre Hospitalier Universitaire Vaudois
Conditions Dementia
Enrollment 92 participants
Start Date 2024-11-15
Primary Completion 2027-03-30 (estimated)
Study Completion 2027-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-04-09