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.

Cognitive Impairment Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04941222
• Other study ID #: CHD187-19
• Status: Terminated
• Phase: N/A
• Start date: July 29, 2021
• Est. completion date: April 5, 2023

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: April 5, 2023
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
France	CHD Vendee	La Roche-sur-Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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