Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: doll therapy.
- Who it may be relevant to
- Registry conditions: Dementia. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Doll Therapy in the Control of Behavioral and psychologIcal Symptoms of Dementia in Acute Geriatric Inpatients: the AGITATE Study.
Overview
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.
Interventions
- Other doll therapy
empathy dolls
Primary outcome measures
- agitation and aggressiveness within hospital [Time frame: baseline and hospital discharge discharge (up to one week)]
- behavioural and psychological symptoms of dementia [Time frame: baseline, discharge (up to one week)]
- agitation and aggressiveness outside hospital [Time frame: baseline, 1 and 4 weeks after discharge]
Secondary outcome measures (5)
- incidence of delirium [Time frame: every day during hospital stay (up to one week)]
- patients' quality of life [Time frame: baseline and 4 weeks after discharge]
- family caregivers' quality of life [Time frame: baseline and 4 weeks after discharge]
- professional caregiver burden [Time frame: baseline and at hospital discharge (up to one week)]
- family caregiver burden [Time frame: baseline and 4 weeks after discharge]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- geriatric and Geriatric Rehabilitation Unit — Lausanne
Publications
- Martin-Garcia A, Corregidor-Sanchez AI, Fernandez-Moreno V, Alcantara-Porcuna V, Criado-Alvarez JJ. Effect of Doll Therapy in Behavioral and Psychological Symptoms of Dementia: A Systematic Review. Healthcare (Basel). 2022 Feb 23;10(3):421. doi: 10.3390/healthcare10030421. PMID 35326899
- Molteni V, Vaccaro R, Ballabio R, Ceppi L, Cantu M, Ardito RB, Adenzato M, Poletti B, Guaita A, Pezzati R. Doll Therapy Intervention Reduces Challenging Behaviours of Women with Dementia Living in Nursing Homes: Results from a Randomized Single-Blind Controlled Trial. J Clin Med. 2022 Oct 24;11(21):6262. doi: 10.3390/jcm11216262. PMID 36362489
- James IA, Reichelt K, Shirley L, Moniz-Cook E. Management of Agitation in Behaviours That Challenge in Dementia Care: Multidisciplinary Perspectives on Non-Pharmacological Strategies. Clin Interv Aging. 2023 Feb 18;18:219-230. doi: 10.2147/CIA.S399697. eCollection 2023. PMID 36843632
- Peng Y, Liu Y, Guo Z, Zhang Y, Sha L, Wang X, He Y. Doll therapy for improving behavior, psychology and cognition among older nursing home residents with dementia: A systematic review and meta-analysis. Geriatr Nurs. 2024 Jan-Feb;55:119-129. doi: 10.1016/j.gerinurse.2023.10.025. Epub 2023 Nov 19. PMID 37980780
- Santagata F, Massaia M, D'Amelio P. The doll therapy as a first line treatment for behavioral and psychologic symptoms of dementia in nursing homes residents: a randomized, controlled study. BMC Geriatr. 2021 Oct 12;21(1):545. doi: 10.1186/s12877-021-02496-0. PMID 34641791
Identifiers
NCT: NCT05691569 · agitate