Clinical trial NCT05626205: Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia
Official title: PARO: Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Older Adults
Keywords: technology-based intervention
Alzheimer Disease
Dementia
Older Adults
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall objective of the study is to evaluate the improvement in patient-perceived quality of life following the use of the Paro robot integrated with traditional intervention in the elderly with dementia.

Detailed description: The primary aim of this study is to evaluate the patient-perceived improvement in terms of quality of life through Quality of Life - Alzheimer's Disease (QoL-AD), following the use of the Paro robot, integrated with traditional intervention carried out within the IRCCS INRCA Alzheimer's Day Center.

The Secondary aims are the evaluation of the improvement in cognitive status of the elderly person with dementia, in terms of orientation, attentional-executive, mnestic and visuospatial functions, detected through the Addenbrooke's Cognitive Examination (ACE-R); the assessment of mood improvement in terms of reduction of anxiety and depression, detected through the Rating Anxiety In Dementia (RAID) scale and the Cornell Scale for Depression in Dementia (CSDD); the assessment of the elderly person's acceptance of the technology through Quebec User Evaluation of Satisfaction (QUEST 2.0), semi-structured interview and analysis of physiological activation during interaction, with the Noldus Face Reader system and direct observation by the operator; the analysis of behavioral symptomatology through Neuropsychiatric Inventory (NPI); the assessment of practitioner's acceptance of technology through Technology Acceptance Model (TAM) and the assessment of job quality through semi-structured interview.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild-moderate dementia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM V).
* MMSE between 10 and 24
* Attending the Alzheimer's Day Center since at least 3 months
* Presence of a caregiver

Exclusion Criteria:

* Severe sensory disabilities (visual and auditory)
* Comprehension difficulties
* History of syncopal episodes, epilepsy, and dizziness not controlled pharmacologically
* Severe autonomic system dysfunction
* Severe behavioral syndromes not compensated by medication

Primary outcomes:
measure: changes in quality of life
timeFrame: baseline, 12 and 24 weeks later
Secondary outcomes:
measure: changes in cognitive status
timeFrame: baseline, 12 and 24 weeks later
measure: changes in mood
timeFrame: baseline, 12 and 24 weeks later
measure: changes in signs and symptoms of major depression
timeFrame: baseline, 12 and 24 weeks later
measure: changes in acceptance of the technology
timeFrame: baseline, 12 and 24 weeks later
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS INRCA
name: Roberta Bevilacqua
role: PRINCIPAL_INVESTIGATOR
References: