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.

NCT ID: NCT04941222

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-29
• Study Completion Date: 2023-04-05

Brief Summary

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.

Conditions

Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

With robotic seal "PARO"

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.

Group Type: EXPERIMENTAL

With robotic seal "PARO"

Intervention Type: OTHER

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

Without robotic seal "PARO"

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

With robotic seal "PARO"

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

stéphanie CHENEAU

Role: PRINCIPAL_INVESTIGATOR

CHD Vendée

Locations

CHD Vendee

La Roche-sur-Yon, , France

Countries

France

Other Identifiers

CHD187-19

Identifier Type: -

Identifier Source: org_study_id