Clinical trial NCT06396377: Interest of the Reborn® Doll as a TO in the Care of Residents With Alzheimer's Disease or a Related Disorder
Official title: Interest of the Reborn® Doll as a Therapeutic Object in the Care of Residents With Alzheimer's Disease or a Related Disorder : Pilote Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia Alzheimers
Keywords: Alzheimer
Reborn doll
agitation
behavioural disorders
cognitive disorders
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized parallel-arm trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective of this study is to evaluate the benefits of the Reborn®doll as an OT for the care of residents with Alzheimer's disease or related disorders, by assessing the frequency of resident agitation.

The secondary objectives are to study the frequency of treatments, evaluate the average time of exposure to the Reborn® doll, study the behavior of the residents, study the interest of this therapeutic workshop, thanks to an evaluation grid and finally study the repercussions of this OT on the nursing staff.

Detailed description: Dementia affects 50 million people worldwide, and this number is set to continue rising as the population ages. Indeed, the World Health Organization (WHO) expects this number to reach 82 million by 2030. At present, there is no cure for dementia. In order to limit the need for drug treatments for dementia-related symptoms (agitation, aggression), non-drug treatments can be used to improve residents' lives and soothe them. In the late 1960s, researchers turned their attention to non-medication therapies (snozelen concept, animal mediation, calinotherapy, Tovertafel, Carpe Diem, doll'therapy).

This doll is used by caregivers to calm anxiety attacks, aggression or apathy in residents with MND. The doll helps to calm the elderly by focusing them on an object. Several studies have shown that residents are calmed and feel valued by taking care of the doll. This also helps to avoid physical or chemical restraints, as well as the use of drug therapies in cases of agitation. Reborn® dolls are an evolution of Doll'therappy.

Eligibility criteria: Inclusion Criteria:

* Resident aged 65 and over
* Moderate to severe cognitive impairment diagnosed using the NPI-ES scale
* Behavioral disorders (agitation, aggression, anxiety, apathy) assessed using the NPI-ES scale
* Covered by a social security plan
* Written consent of representative (tutor/ curator/trusted person)

Exclusion Criteria:

* Resident or representative refusing to participate
* Resident under judicial protection

Primary outcomes:
measure: Episodes of resident agitation using the Cohen Mansfield scale
timeFrame: During the study period (4 weeks)
Secondary outcomes:
measure: Factors that can affect doll benefits: gender, age, pathology, Charlson Comorbidity Index, doll identifier.
timeFrame: Inclusion
measure: Drug treatments
timeFrame: During the study period (4 weeks)
measure: Average exposure time to Reborn®dolls
timeFrame: During the study period (4 weeks)
measure: Therapeutic evaluation scale
timeFrame: During the study period (4 weeks)
measure: Quality of working life questionnaire
timeFrame: During the study period (4 weeks)
measure: Resident behavior following OT withdrawal
timeFrame: During the study period (4 weeks)
measure: Resident behavior after OT exposure
timeFrame: During the study period (4 weeks)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Chloé Afonso
role: PRINCIPAL_INVESTIGATOR
References: