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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.

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.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04941222
Acronym
PEPINO
Enrollment
33
Registered
2021-06-28
Start date
2021-07-29
Completion date
2023-04-05
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment

Keywords

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

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.

Interventions

OTHERWith 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

Sponsors

Centre Hospitalier Departemental Vendee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incremental cost-utility ratio16 weeks after implementation of toilets with/without PAROIncremental cost-utility ratio (cost/QALY) from a societal perspective and a time horizon of 16 weeks of the use of the PARO robot

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026