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Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients

Study acronym: AGITATE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Mar 30, 2026 to Mar 30, 2027
    • Study completion date: Aug 30, 2026 to Aug 30, 2027
    • Start date changed from estimate of Oct 2024 to Nov 15, 2024
    • Publications: 1 to 5
  2. Start date: Jun 2024 to Oct 2024
    • Primary completion date: Dec 30, 2025 to Mar 30, 2026
    • Study completion date: May 31, 2026 to Aug 30, 2026
    v4
  3. Start date: Sep 2023 to Jun 2024v3
  4. Start date: Feb 28, 2023 to Sep 2023v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05691569
Lead Sponsor Centre Hospitalier Universitaire Vaudois
Conditions
(from sponsor)		 Dementia
Related terms Dementia
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov