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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. (PEPINO)

Primary Purpose

Cognitive Impairment

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
With robotic seal "PARO"
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cognitive Impairment focused on measuring PARO, non-pharmacological intervention, economic evaluation, Cognitive Impairment

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHD Vendee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

With robotic seal "PARO"

Without robotic seal "PARO"

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 18, 2021
Last Updated
August 29, 2023
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT04941222
Brief Title
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.
Acronym
PEPINO
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulties of recruitment
Study Start Date
July 29, 2021 (Actual)
Primary Completion Date
April 5, 2023 (Actual)
Study Completion Date
April 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
Keywords
PARO, non-pharmacological intervention, economic evaluation, Cognitive Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With robotic seal "PARO"
Arm Type
Experimental
Arm 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.
Arm Title
Without robotic seal "PARO"
Arm Type
No Intervention
Arm Description
The care of the patient during the toilet will be carried out according to the modalities currently in use in the facility.
Intervention Type
Other
Intervention Name(s)
With robotic seal "PARO"
Intervention Description
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
Primary Outcome Measure Information:
Title
Incremental cost-utility ratio
Description
Incremental cost-utility ratio (cost/QALY) from a societal perspective and a time horizon of 16 weeks of the use of the PARO robot
Time Frame
16 weeks after implementation of toilets with/without PARO

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
stéphanie CHENEAU
Organizational Affiliation
CHD Vendée
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHD Vendee
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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.

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