Measuring the Impact of a Socially Assistive Robot

NCT04848155 | Completed

• 1 other identifier: B6702020000244
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Due to increasing age and an increasing prevalence rate of neurocognitive disorders such as Mild Cognitive Impairment and dementia, independent living may become challenging. The use of socially assistive robots is one solution that can enable older adults with cognitive impairment to remain independent. However, at present, there is a lack of knowledge about the impact of assistive robots on older adults with MCI and their caregivers. A 12-month trial will be conducted to measure the impact of the robot. A total of 120 participants living in independent living facilities, nursing homes or patients part of a rehabilitation program will be recruited. The outcome measures will be defined based on experiences from previous pilot trials with the robot. The primary outcomes will be active engagement and loneliness. Participation, physical and cognitive functioning will be defined as the secondary outcomes.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Change from baseline Active Engagement at month 6

  Active engagement will be assessed using a time-sampling method. A scoring form will be adapted based on a protocol called 'Video Coding Incorporating Observed Emotion' (VC-IOE).

  baseline, month 6

• Change from baseline Loneliness at month 6

  Loneliness will be assessed by De Jong-Gierveld 11-item Loneliness Scale. Scores range between 0-11 points, with a higher score indicating stronger feelings of loneliness. Score 0-2: not lonely, score 3-11: lonely. Within the lonely people, a distinction can be made between moderate lonely people (scoring 3 to 8) and strong lonely people (scoring 9 to 11). The instrument is divided into two subscales: emotional and social loneliness. Social loneliness occurs when someone is missing a wider social network. Emotional loneliness refers to missing an "intimate" relationship or friendship.

  baseline, month 6

Secondary Outcomes (3)

• Change from baseline Physical functioning at month 6

  baseline, month 6

• Change from baseline Cognitive functioning at month 6

  baseline, month 6

• Change from baseline Participation level at month 6

  baseline, month 6

Study Arms (2)

Older adults with MCI

ACTIVE COMPARATOR

Other: socially assistive robot

Caregivers

ACTIVE COMPARATOR

Other: socially assistive robot

Interventions

socially assistive robot OTHER

The intervention group will work with the ReMIND-system. This ReMIND-system consists of: 1. An existing socially assistive robot called James® that will be adapted based on the needs of the older adults and the robot's own functionality. For example, exercise videos and games to stimulate physical and cognitive activity will be developed and made available on the robot. The robot has to be programmed by the researcher using the ZBOS Control© application on a separate tablet that is connected to the robot. 2. The "Keosity"-app, an application specifically designed to support people in telling, documenting and sharing their life stories with others. This application will be available on the robot.

Caregivers; Older adults with MCI

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65+
• Score range of 19/30 - 25/30 on Montreal Cognitive Assessment (MoCA)
• Ability to walk independently with or without assistive device

You may not qualify if:

• Health conditions that do not allow participation in a physical intervention
• Planned surgery or hospitalisation within 12 months of the trial
• Insufficient language skills
• History of severe neurological (e.g. stroke) or psychiatric (e.g. depression) condition
• Severe vision impairment / hearing loss
• Participation in another study to test a new technology

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Robotics

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Automation; Technology; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 19, 2021
• Study Start: October 12, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)