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.

NCT04941222 | Terminated

• 1 other identifier: CHD187-19
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

PARO; non-pharmacological intervention; economic evaluation; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

With robotic seal "PARO"

EXPERIMENTAL

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"

Without robotic seal "PARO"

NO INTERVENTION

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

Interventions

With robotic seal "PARO" 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

With robotic seal "PARO"

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Patient not affiliated to a social security system or beneficiary of such a system

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

CHD Vendee

La Roche-sur-Yon, 85925, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• stéphanie CHENEAU

  CHD Vendée

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 28, 2021
• Study Start: July 29, 2021
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)