Clinical trial NCT05691569: Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients
Official title: Efficacy of Doll Therapy in the Control of Behavioral and psychologIcal Symptoms of Dementia in Acute Geriatric Inpatients: the AGITATE Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 92
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled open label trial with two parallel arms
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: agitation and aggressiveness within hospital
timeFrame: baseline and hospital discharge discharge (up to one week)
measure: behavioural and psychological symptoms of dementia
timeFrame: baseline, discharge (up to one week)
measure: agitation and aggressiveness outside hospital
timeFrame: baseline, 1 and 4 weeks after discharge
Secondary outcomes:
measure: incidence of delirium
timeFrame: every day during hospital stay (up to one week)
measure: patients' quality of life
timeFrame: baseline and 4 weeks after discharge
measure: family caregivers' quality of life
timeFrame: baseline and 4 weeks after discharge
measure: professional caregiver burden
timeFrame: baseline and at hospital discharge (up to one week)
measure: family caregiver burden
timeFrame: baseline and 4 weeks after discharge
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: geriatric and Geriatric Rehabilitation Unit
state: Vaud
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.