NCT05691569 Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients
| NCT ID | NCT05691569 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Vaudois |
| Condition | Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2024-11-15 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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; * infectious diseases requiring isolation; * negative interaction with the doll, * presence of delirium.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05691569 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05691569 currently recruiting?
Yes, NCT05691569 is actively recruiting participants. Contact the research team at patrizia.damelio@chuv.ch for enrollment information.
Where is the NCT05691569 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT05691569 clinical trial?
NCT05691569 is sponsored by Centre Hospitalier Universitaire Vaudois. The trial plans to enroll 92 participants.