Cost-utility Analysis of the Use of the Paro Robotic Seal by Elderly Patients With Moderate or Severe Cognitive Disorders in Institutions: a Randomised Study.

Study Overview
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Brief Summary
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Many residents from establishments for dependent elderly people (EHPAD) have memory disorders with behavioural problems such as agitation, aggression and anxiety, which make it difficult to assist them on a daily basis. Studies have proven the beneficial effect of the therapeutic seal robot PARO® in behavioural disorders. The present project aims to complement these data with a medico-economic study. At present, the only study of this type has been carried out in Australia, and is not transposable to France.

Official Title
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Cost-utility Analysis of the Use of the Paro Robotic Seal by Elderly Patients With Moderate or Severe Cognitive Disorders in Institutions: a Randomised Study.

Conditions
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Cognitive Impairment

Intervention / Treatment
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* Other: With robotic seal PARO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 70 years of age With moderate or severe neurocognitive disorders of any etiology (Mini Mental State Examination (MMSE) less than or equal to 20, or not feasible) Resident in EHPAD (establishment for dependent elderly people) or USLD (long-term care unit ) in permanent accommodation for more than 1 month at inclusion Exclusion Criteria: Patient with presumed life expectancy of less than 3 months Mini Mental State Examination (MMSE) not feasible for any reason other than cognitive impairment (e.g. stroke aphasia), without dementia Known carrier of multi-drug resistant bacteria Carrier of Pace-maker (precautionary advice from manufacturer) Refusal to participate to the study (trusted person, guardian or curator or patient depending on the patient's mental state) Patient under court protection Prior inclusion in an interventional study that may alter the interpretation of the results of the analysis Patient not affiliated to a social security system or beneficiary of such a system

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With robotic seal PARO<br>The robot will be made available to the patient by the caregiver in charge of the patient for 5 minutes before a toilet and for the duration of the treatment (about 10 minutes), twice a week for 16 weeks. | Other: With robotic seal PARO<br>* The PARO robot will be made available to the patient by the caregiver in charge of the patient for 5mn before a toilet and during the duration of the care (about 10mn), at the frequency of twice a week for 16 weeks<br>|
| No Intervention: Without robotic seal PARO<br>The care of the patient during the toilet will be carried out according to the modalities currently in use in the facility. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental cost-utility ratio | Incremental cost-utility ratio (cost/QALY) from a societal perspective and a time horizon of 16 weeks of the use of the PARO robot | 16 weeks after implementation of toilets with/without PARO | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PARO, non-pharmacological intervention, economic evaluation, Cognitive Impairment