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)

September 18, 2025 updated by: Centre Hospitalier Departemental Vendee

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Roche-sur-Yon, France, 85925
        • CHD Vendee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental cost-utility ratio
Time Frame: 16 weeks after implementation of toilets with/without PARO
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Principal Investigator: stéphanie CHENEAU, CHD Vendee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2021

Primary Completion (Actual)

April 5, 2023

Study Completion (Actual)

April 5, 2023

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 18, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD187-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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