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

Study Overview
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Brief Summary
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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.

Detailed Description
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This project contains three studies. Study 1 will use a randomized controlled trial to examine the effect of Paro (social robot) intervention on oxytocin, dopamine, and HRV variations 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 for specific attachment older adults with dementia before, during, and after the intervention. A sample of 120 older adults with dementia who are 65 years or older living in long-term care will be invited. Older adults will be randomly assigned to two groups: experimental group or control group. The outcomes will be assessed based on the change of dopamine and HRV at baseline, 3rd week during the Paro intervention, the end of intervention (6th week), and the 1 month after the Paro intervention. Furthermore, the change of oxytocin will be assessed at two time points: baseline and the end of Paro intervention. Study 2 will focus on the 60 participants of the 2 experimental groups. A mixed-method combined qualitative and quantitative research design will be used to explore the participating experience, group interaction, and its' association with mental health. Based on study 1 design, the outcomes of study 3 will be assessed based on the change of cognitive, executive functions, loneliness, depression, and well-being at the same points of study 1. In addition, the Revised Adult Attachment Scale Chinese version (RAAS-C) will be used to classify the attachment types of the elderly. A sub-group analysis will be conducted to further understand the changes in the physical and mental health of the elderly with different attachment types after receiving Paro intervention. The results of this study will be used to provide empirical evidence to identify the effectiveness of Paro intervention on neurobiologically changes, cognition, executive functions, and mental well-being for older people with dementia. These results can be promoted as a care model in long-term facilities in the future.

Official Title
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National Tainan Junior College of Nursing

Conditions
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Dementia, Mild, Dementia Moderate, Cognitive Impairment

Intervention / Treatment
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* Device: Paro (social robot) intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (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 Exclusion Criteria: (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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trail, single-blind, two parallel groups, and repeated measures design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paro intervention group<br>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<br>* 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<br>|
| No Intervention: control group<br>The control group will receive care as usual activities, such as painting, drawing, and craft, which are provided by each facility. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group atmosphere | The Chinese version of the group climate questionnaire, 12 items, was developed by Zhong et al. (2013). This questionnaire consists three main dimensions including engagement (5 items), conflict (3 items), and avoidance (4 items). Each item on the scale is rated from 1 (Never) to 4 (Often) with a total score ranging from 12 to 48. The scale does not identify a cut-off score that defines good or bad group climate. The higher the score, the more better group atmosphere participant perceived. | week-1, week-3 and week-10 | 
| Group satisfaction | The group satisfaction scale was developed Keyton (1991). The Chinese version of group satisfaction scale, which consists 14 items, was translated and modified by Lin. This questionnaire consists five main dimensions including group process feelings, attitudes of leaders, attitudes of group members, group acceptance, group equality. Each item on the scale is rated from 1 (very satisfied) to 5 (very dissatisfied) with a total score ranging from 14 to 70.The higher the score, the more dissatisfied the group is. | week-1, week-3 and week-6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paro, Dementia, Neurobiology, Cognitive Function, Mental well-being