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.
Not Applicable
Terminated
- Conditions
- Cognitive Impairment
- Interventions
- Other: With robotic seal "PARO"
- Registration Number
- NCT04941222
- Lead Sponsor
- Centre Hospitalier Departemental Vendee
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 33
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description With robotic seal "PARO" 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHD Vendee
🇫🇷La Roche-sur-Yon, France