Effectiveness of doll therapy in controlling behavioral and psychological symptoms of dementia: the AGITATE study.
Résumé de l'étude
Behavioral and psychological symptoms of dementia (BPSD) represent a significant burden for patients and their families. BPSD worsen during hospitalization and require the administration of psychotropics, which are often insufficient to control them and can cause serious side effects. A non-pharmacological approach is recommended as a first-line treatment for BPSD. The AGITATE study will test the effectiveness of doll therapy (DT) to reduce BPSD, particularly agitation and aggression (A/A) in patients with moderate or severe dementia hospitalized in geriatrics. The project's objectives are to evaluate the effect of DT on: patient agitation and aggression, patient quality of life, workload for professionals and families, quality of life for family members assisting the patient. The effectiveness of DT will be assessed by randomly assigning the patient to DT or to a treatment with a cushion that has no human appearance but whose weight and tactile sensation are similar to that of the doll. The study will last 36 months. Geriatric patients hospitalized in the acute geriatric unit of the Lausanne University Hospital (CHUV) will be recruited. The presence of A/A and other BPSD will be assessed using appropriate scales at baseline, at the end, and 1 and 4 weeks after hospitalization. The presence of delirium will also be diagnosed. We will also evaluate the quality of life of patients and families, as well as mood at the beginning and end of the study. The workload and stress of professionals and family members caring for the patient will also be evaluated. Patients and families will be assessed at inclusion, at discharge from the hospital, one week after discharge, and four weeks after. To obtain significant results, we will recruit 120 patients.
(BASEC)
Intervention étudiée
The doll used in the study is the "empathy doll"; these dolls are designed to achieve optimal interaction with patients and to elicit empathy. The administration of DT will be standardized. In the control group, a non-anthropomorphic object (a soft cushion) will be used according to the same protocol as the doll. If agitation persists, psychotropic medications will be administered as needed, in accordance with standard clinical practices.
(BASEC)
Maladie en cours d'investigation
Moderate or severe dementia complicated by behavioral and psychological symptoms, particularly agitation and aggression
(BASEC)
Patients: age ≥ 65 years; diagnosis of moderate to severe dementia according to the Clinical Dementia Rating (CDR) ≥ 2; presence of agitation and/or aggression; sufficient manual and visual abilities to interact with the doll. Direct informed consent, documented by the signature of the patient's delegate. Family members of patients: willing to participate in the study, age ≥ 18 years, good understanding of French. (BASEC)
Critères d'exclusion
Patients: age < 65 years; refusal to participate; mild forms of dementia (CDR < 2); contraindication to DT such as a bereavement or trauma experience related to parenting; life expectancy less than 3 months; infectious diseases requiring isolation; negative interaction with the doll; presence of delirium. Family members of patients: refusal to give their consent. (BASEC)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
CHUV
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Patrizia D'Amelio
+410213143712
patrizia.damelio@clutterchuv.chcentre hospitalier et Universitaire Vaudoise
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
25.06.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT05691569 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Efficacy of Doll therapy in the control of behAvioral and psycholoGIcal sympToms of dementiA in acuTe gEriatric inpatients: the AGITATE study. (BASEC)
Titre académique
Efficacy of Doll Therapy in the Control of Behavioral and psychologIcal Symptoms of Dementia in Acute Geriatric Inpatients: the AGITATE Study. (ICTRP)
Titre public
Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients (ICTRP)
Maladie en cours d'investigation
Dementia (ICTRP)
Intervention étudiée
Other: doll therapy (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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. (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
agitation and aggressiveness within hospital;behavioural and psychological symptoms of dementia;agitation and aggressiveness outside hospital (ICTRP)
incidence of delirium;patients' quality of life;family caregivers' quality of life;professional caregiver burden;family caregiver burden (ICTRP)
Date d'enregistrement
29.11.2022 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Patrizia D Amelio, MD, PhDPatrizia D'Amelio, MD, PhD, patrizia.damelio@chuv.chpatrizia.damelio@chuv.ch, +41213143712+41213143712 (ICTRP)
ID secondaires
agitate (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05691569 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible