PEPINO: 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.

Sponsor

Centre Hospitalier Departemental Vendee (Other)

Overall Status

Recruiting

CT.gov ID

NCT04941222

Collaborator

(none)

136

Enrollment

Location

Arms

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Impairment	Other: With robotic seal "PARO"	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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.

Actual Study Start Date :

Jul 29, 2021

Anticipated Primary Completion Date :

May 29, 2023

Anticipated Study Completion Date :

May 29, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incremental cost-utility ratio [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts 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