Viewing Study NCT05691569


Ignite Creation Date: 2025-12-24 @ 11:08 PM
Ignite Modification Date: 2025-12-25 @ 8:41 PM
Study NCT ID: NCT05691569
Status: RECRUITING
Last Update Posted: 2025-04-09
First Post: 2022-11-29
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients
Sponsor: Centre Hospitalier Universitaire Vaudois
Organization:

Study Overview

Official Title: Efficacy of Doll Therapy in the Control of Behavioral and psychologIcal Symptoms of Dementia in Acute Geriatric Inpatients: the AGITATE Study.
Status: RECRUITING
Status Verified Date: 2025-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: AGITATE
Brief 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: