Clinical trial NCT05102201: Effect of the Group-based Paro Intervention on Physiological and Psychological Outcomes
Official title: National Tainan Junior College of Nursing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia, Mild
Dementia Moderate
Cognitive Impairment
Keywords: Dementia
Paro
Neurobiology
Cognitive Function
Mental well-being
Lead sponsor: National Tainan Junior College of Nursing
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 118
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trail, single-blind, two parallel groups, and repeated measures design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxytocin
timeFrame: Change from Baseline Oxytocin at 6 weeks
measure: Finger tapping test (FTT)
timeFrame: Change from Baseline FTT at 6 weeks
measure: HRV measurements
timeFrame: Change from Baseline HRV at 6 weeks
measure: The Chinese version of Mini-Mental State Examination (MMSE)
timeFrame: Change from Baseline MMSE at 6 weeks
measure: Core components of executive functions- WM and response inhibition
timeFrame: Change from Baseline WM and response inhibition at 6 weeks
measure: Core components of executive functions- WM(1) -Verbal WM task
timeFrame: Change from Baseline Verbal WM task at 6 weeks
measure: Core components of executive functions- WM(2)-Visuo-spatial WM task
timeFrame: Change from Baseline Verbal WM task at 6 weeks
measure: Core components of executive functions- response inhibition (1)-Color word Stroop task
timeFrame: Change from Baseline Color word Stroop task at 6 weeks
measure: Core components of executive functions- response inhibition (2)-Stop signal task
timeFrame: Change from Baseline Stop signal task at 6 weeks
measure: Core components of executive functions- response inhibition (3)-Go/no-go task
timeFrame: Change from Baseline Go/no-go task at 6 weeks
measure: Geriatric Depression Scale - Short Form (GDS-SF)
timeFrame: Change from Baseline GDS-SF at 6 weeks
measure: The UCLA Loneliness Scale version 3 (UCLA-3)
timeFrame: Change from Baseline UCLA-3 at 6 weeks
measure: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
timeFrame: Change from Baseline WEMWBS at 6 weeks
Secondary outcomes:
measure: Group atmosphere
timeFrame: week-1, week-3 and week-10
measure: Group satisfaction
timeFrame: week-1, week-3 and week-6
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: National Cheng Kung University Hospital Dou-Liou Branch
Study officials:
References: