Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia

Alzheimer Disease Clinical Trial

— PARO  

Official title:

PARO: Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05626205
• Other study ID #: INRCA_006_2022
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: March 2024
• Source: Istituto Nazionale di Ricovero e Cura per Anziani
• Contact: Anna Rita Bonfigli
• Phone: 00390718003719
• Email: a.bonfigli[@]inrca.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Older Adults

Intervention

Device:
• PARO robot
PARO is an advanced interactive robot. It allows the documented benefits of animal therapy to be administered to patients in environments such as hospitals and extended care facilities where live animals present treatment or logistical difficulties. PARO has five kinds of sensors: tactile, light, audition, temperature, and posture sensors, with which it can perceive people and its environment. PARO can learn to behave in a way that the user prefers, and to respond to its new name.

Locations

Country	Name	City	State
Italy	IRCCS INRCA Hospital	Ancona

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in quality of life	This outcome will be assesed by the Quality of life in Alzheimer's Disease (QoL-AD) test. The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.	baseline, 12 and 24 weeks later
Secondary	changes in cognitive status	This outcome will be assessed by the Addenbrooke's Cognitive Examination (ACE-R). It contains5 sub-scores, each one representing one cognitivedomain: attention/orientation (18 points), memory(26 points), fluency (14 points), language (26 points)and visuospatial (16 points). ACE-R maximum score is 100, composed by the addition of the all domains. is scored out of 100, with a higher score denoting better cognitive function.	baseline, 12 and 24 weeks later
Secondary	changes in mood	This outcome will be assessed by the Rating Anxiety In Dementia (RAID). Rating should be based on symptoms and signs occurring during two weeks prior to the interview. No score should be given if symptoms result from physical disability or illness. Total score is the sum of items 1 to 18.; A score of 11 or more suggests significant clinical anxiety.	baseline, 12 and 24 weeks later
Secondary	changes in signs and symptoms of major depression	This outcome will be assessed by the Cornell Scale for Depression in Dementia (CSDD). Information is elicited through two semi-structured interviews: an interview of an informant and an interview of the patient. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 as a rule are associated with absence of significant depressive symptoms.	baseline, 12 and 24 weeks later
Secondary	changes in acceptance of the technology	This outcome will be assessed by the technology through Quebec User Evaluation of Satisfaction (QUEST 2.0). The QUEST 2.0 evaluates the patient's satisfaction with various assistive technologies.	baseline, 12 and 24 weeks later