Effect of the Group-based Paro Intervention on Physiological and Psychological Outcomes

NCT05102201 | Completed

• 1 other identifier: Shu-Chuan Chen
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

This project contains three studies. This study will use a pilot randomized controlled trial to examine the effect of Paro (social robot) intervention on oxytocin, dopamine, and HRV variations and mental well-being for specific attachment older adults with dementia. A randomized controlled trial, single-blind, two parallel groups, and repeated measures design were used to examine the effects of Paro intervention on neurobiologically changes and mental well-being for specific attachment older adults with dementia before, during, and after the intervention.

Conditions

Dementia, Mild; Dementia Moderate; Cognitive Impairment

Keywords

Dementia; Paro; Neurobiology; Cognitive Function; Mental well-being

Outcome Measures

Primary Outcomes (13)

• Oxytocin

  Blood samples for the oxytocin assay will collected from the antecubital vein into pre-chilled 5 ml EDTA tubes with 250 KIU of apoprotinin, and refrigerated until processing.

  Change from Baseline Oxytocin at 6 weeks

• Finger tapping test (FTT)

  The FTT consists of tapping with the index finger on a computer mouse as many times as possible within 60 second.

  Change from Baseline FTT at 6 weeks

• HRV measurements

  It collects in this study using the Wireless Physiological Feedback System (Model NeXus 4) manufactured by Mind Media in the Netherlands. This device sets 400 signal acquisitions per minute and regularly corrects the device to maintain good reliability. Signal acquisition is managed, corrected, and heart rate frequency calculated by BioTrace+ software (Mind Media). Autonomic neuro physiological status reflect by the amplitude of high-frequency (HF) and low-frequency (LF) waveforms that were analyzed with the LF/HF ratio.

  Change from Baseline HRV at 6 weeks

• The Chinese version of Mini-Mental State Examination (MMSE)

  The MMSE is a widely used tool that screens for levels of cognitive impairment, using the concepts of orientation, registration, attention and calculation, recall, and language. The MMSE score ranges from 0 to 30. In general, a cut-off point higher than 24 indicates normal cognition; 20-23 mild cognitive impairment; 10-19 moderate cognitive impairment; and 0-9 severe cognitive impairment.

  Change from Baseline MMSE at 6 weeks

• Core components of executive functions- WM and response inhibition

  The two core executive functions, WM and inhibition, were assessed using computerized tasks. Working memory was assessed using verbal WM and visuo-spatial WM tasks. Response inhibition was assessed using CWS, SS and GNG tasks.

  Change from Baseline WM and response inhibition at 6 weeks

• Core components of executive functions- WM(1) -Verbal WM task

  Verbal WM task: These are powerpoint slides. Each slide has different numbers of red circles with squares as distracters. The task is to count the total number of red circles in each slide, keep the total in memory and recall the numbers in the correct order. The test starts with a length of memory recall (span) of two, that is, the participant had to recall two slides first. Each level of memory recall consists of three trials and the test is concluded when the participant failed two trials out of three at that same length of recall. If the participant is successful in 2 out of three trials, he/ she is allowed to go to the next span. A total score is calculated after adding a mark for each correct recall.

  Change from Baseline Verbal WM task at 6 weeks

• Core components of executive functions- WM(2)-Visuo-spatial WM task

  Visuo-spatial WM task: A 4 × 4 matrix with 16 squares is displayed on the computer screen as a pig house with a pig appearing in each window one at a time. The task is to recall in reverse order the locations where each target (pig) has appeared. The test start with a span length of two, that is, two pigs appear one after another. Each span consist of two trials and the test is concluded when the participant failed both trials at that same span length. Each correct location is given one point with a maximum score of 88. The score is taken as the measure of Visuo-spatial WM. At the end of the test, obtain score is automatically displayed on the computer screen.

  Change from Baseline Verbal WM task at 6 weeks

• Core components of executive functions- response inhibition (1)-Color word Stroop task

  Color word Stroop task: In this task different colour words will appear on the computer screen one at a time. The task is to name the color the word is printed, disregarding what the color word reads. The colour of the word printed is in the same color as the meaning of the word (congruent trials, eg; "red" is printed in red colour), or it is different from the meaning (incongruent trials, eg; word "green" is printed in blue colour). There are 75 congruent trials and 25 incongruent trials for one test session. Incorrect responses on incongruent trials are taken to assess the level of inhibitory control. The higher the errors the lower the interference control is.

  Change from Baseline Color word Stroop task at 6 weeks

• Core components of executive functions- response inhibition (2)-Stop signal task

  Stop signal task: It assess the ability to inhibit ongoing responses. This is like a car game where a car appears on the computer screen. Every time the car appear, the participant is supposed to press a designated key as fast as possible to drive the car away. But when a stop-sign board appeared next to the car, participants has to refrain from pressing for the car to stand still. Each session in this task consist of 24 trials with six stop-signs-trials. Number of incorrect presses in stop sign (commission errors) is considered as the measure of inhibition and it is automatically displayed on the screen at the end of the task.

  Change from Baseline Stop signal task at 6 weeks

• Core components of executive functions- response inhibition (3)-Go/no-go task

  Go/no-go task (two versions: colour and shape): It assess ability to inhibit pre potent responses. The subject is presented with four different stimuli on the screen, one at a time in random order. There are two squares and two circles in blue and red. In the first session, the subject is instructed to respond by pressing a key each time when a blue figure appeared (go-trials) regardless of the shape, and not to respond when a red figure appear. In the second session, the subject is instructed to respond each time when a square appear, regardless of the color, and not to respond when a circle appear. Together the two consecutive sessions include 60 stimuli with 77% go-trials. The number of incorrect responses (commission errors) is used as a measure of inhibition and it is automatically displayed on the screen at the end of the task.

  Change from Baseline Go/no-go task at 6 weeks

• Geriatric Depression Scale - Short Form (GDS-SF)

  The GDS-SF consists of 15 items with 10 positive items and 5 negative items and has been found to be a useful tool to detect depressive symptoms in older populations. The scores range from 0-21 and a cut-off point of 6 or more indicates the presence of depression.

  Change from Baseline GDS-SF at 6 weeks

• The UCLA Loneliness Scale version 3 (UCLA-3)

  The UCLA loneliness is used to measure a person's subjective feelings of loneliness and feelings of isolation. Each item on the scale is rated from 1 (Never) to 4 (Often) with a total score ranging from 20 to 80. The scale does not identify a cut-off score that defines loneliness. The higher the score, the more severe a person's feelings of loneliness.

  Change from Baseline UCLA-3 at 6 weeks

• Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

  The WEMWBS scale was developed by researchers at the Universities of Warwick and Edinburgh (2006), including 14 items of mental well-being covering subjective well-being and psychological functioning. The scale is scored by summing responses to each item answered on a 5 points Likert scale and the scores range from 14 - 70. The higher the score, the better the mental well-being.

  Change from Baseline WEMWBS at 6 weeks

Secondary Outcomes (2)

• Group atmosphere

  week-1, week-3 and week-10

• Group satisfaction

  week-1, week-3 and week-6

Study Arms (2)

Paro intervention group

EXPERIMENTAL

Participants in the Paro intervention group will receive a group (6-8 people as a group), facilitated, and 30-minute weekly session Paro intervention for 6 weeks.

Device: Paro (social robot) intervention

control group

NO INTERVENTION

The control group will receive care as usual activities, such as painting, drawing, and craft, which are provided by each facility.

Interventions

Paro (social robot) intervention DEVICE

Participants in the Paro group will receive a group (6-8 people as a group), facilitated, and 30-minute weekly session Paro intervention for 6 weeks

Paro intervention group

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Eligibility is based on gender which is a person's self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• (1) aged 65 years or over; (2) Mild to moderator dementia (3) an ability to communicate in Mandarin or Taiwanese; and (4) has been living in the LTC facility at least 3 months

You may not qualify if:

• (1) have severe difficulty in communication; (2) are totally dependent on carers for daily activity; (3) have a diagnosed infectious disease, severe dementia, and severe mental illness such as schizophrenia and delusional disorder

Sponsors & Collaborators

• National Tainan Junior College of Nursing: lead

Study Sites (1)

National Cheng Kung University Hospital Dou-Liou Branch

Douliu, 640, Taiwan

Location

MeSH Terms

Conditions

Dementia; Lymphoma, Follicular; Cognitive Dysfunction; Psychological Well-Being

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cognition Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Allocation to treatment groups was concealed from participants until it was operationally required to begin intervention activities (ie, postbaseline data collection). Research assistants involved in data collection and data coding were masked to the other intervention groups through assignment of work to 1 group only, and by separate working locations. Intervention RAs were allocated to specific facilities, working with only one of the groups, and were masked to all outcome measurements, as were participants.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 78, Sec. 2, Minzu Rd., West Central Dist., Tainan City 700007, Taiwan, R.O.C.

Model Details: A randomized controlled trail, single-blind, two parallel groups, and repeated measures design

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: November 1, 2021
• Study Start: March 22, 2022
• Primary Completion: May 24, 2022
• Study Completion: May 30, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

TW (1)