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. (PEPINO)

Centre Hospitalier Departemental Vendee

Status: Terminated

Conditions: Cognitive Impairment

Treatments: Other: With robotic seal "PARO"

Study type: Interventional

Funder types: Other

Identifiers

NCT04941222

CHD187-19

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

With robotic seal "PARO"

Experimental group

Description:

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.

Treatment:

Other: With robotic seal "PARO"

Without robotic seal "PARO"

No Intervention group

Description:

The care of the patient during the toilet will be carried out according to the modalities currently in use in the facility.