Mild Cognitive ImpairmentNCT04848155
Measuring the Impact of a Socially Assistive Robot
A study testing socially assistive robot in people with Mild Cognitive Impairment, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- socially assistive robot
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Oct 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65+
- Score range of 19/30 - 25/30 on Montreal Cognitive Assessment (MoCA)
- Ability to walk independently with or without assistive device
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring the Impact of Socially Assistive Robot on Older Adults With MCI and Their Caregivers
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.
Read the detailed description
The objective of the current study is to evaluate the impact of the robot using a cross-over design.
- Recruitment An existing database with facilities, built up in the previous phases of the project, will be used to recruit new participants. Sample Size calculations were done a priori using G*Power, based on an effect size of 0.4 and testing the difference between two dependent means. According to these calculations, a total sample size of 62 would allow us to detect significant differences among the mean values on the primary outcome measures (α =.025 and power =.8).
- Handling Missing Data Since the reason for dropouts might be of great importance for the results of this study, they will be taken into account. Therefore, the Intention To Treat (ITT) approach will be applied.
- Data Analysis
- Quantitative Analysis
Descriptive statistics will be employed to describe the characteristics of the participants. Distribution of data will be assessed by inspecting the histograms and by appropriate tests, e.g. Shapiro-Wilk Test. Data will be visualized using bar charts (categorical variables) and/or box plots (continuous variables). If appropriate, independent t-tests will be used at baseline data to investigate whether or not there are significant differences between both groups. Alternatively, in case of non-normal distributed data, Mann Whitney-U tests will be applied instead.
Active Engagement Evaluation will be performed at baseline, after 3 months, 6 months, 9 months and 12 months in the study with both group A and B. Primary endpoint is the comparison "no robot" vs "robot" at 6 months within that period. Active Engagement will be calculated by comparing the data of the intervention and control group after 6 months and 12 months with counts (the number of times the person shows a certain behavior at a certain time point during the activity) as the outcome variable. Data will be analyzed using a mixed negative binominal regression, with the subjects considered the random factor and the following variables as fixed effects: (1) condition (robot vs no robot), (2) time (baseline, 3 and 6 months) and (3) interaction between condition and time.
Loneliness Evaluation will be performed at baseline, after 3 months, 6 months, 9 months and 12 months in the study with both group A and B. Primary endpoint is the comparison "no robot" vs "robot" at 6 months within that period. Loneliness will be calculated by comparing the scores on the (full) loneliness scale of the intervention group and the control group after 6 and 12 months. Data will be analyzed using a mixed linear regression, with "loneliness" as the outcome variable and the following variables as fixed effects: (1) condition (robot vs no robot), (2) time (baseline, 3 and 6 months) and (3) interaction between condition and time. The subjects in the study are considered the random factor.
Secondary outcomes Evaluation will be performed at baseline, after 3 months, 6 months, 9 months and 12 months in the study with both group A and B. Primary endpoint is the comparison "no robot" vs "robot" at 6 months within that period. For analyzing the data of the secondary outcomes (physical functioning, cognitive functioning and participation), a linear mixed model will be used (similar to the primary outcomes) if data is distributed normally.
Since multiple comparisons are made, a Bonferroni correction will be applied. The Bonferroni-corrected level of statistical significance will be set at α = .025. Data analyses will be conducted by SPSS Statistics software. For the secondary outcomes, statistical significance will be set at a level of p<.05.
2 - Qualitative Analysis
Focus groups will be conducted after 6 and 12 months to receive feedback from the caregivers. Inductive thematic analysis will be used to analyze the data from the focus groups. This will be done according to the guideline designed by Braun and Clarke (2006), which describes different phases in the process of conducting thematic analysis. In the first phase, the researcher becomes familiarized with the data by a thorough (re)reading from the data from the focus groups. Initial ideas that could possibly be of value will be noted down. The second phase consists of the coding process, where interesting features in the data are being labeled and initial codes will be produced. An interpretative analysis of the data occurs and similarities in the codes will be identified, generating potential themes. These themes will be discussed within the research team and further refined in the next phase, where clear definitions and names will be generated. The analysis will be carried out by the corresponding researcher from each test-site. This in order to enable a focus on the different perspectives resulting from the different settings where the study will be conducted.
- Conditions
- Mild Cognitive Impairment
- Being tested
- socially assistive robot
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socially assistive robotOther
The intervention group will work with the ReMIND-system. This ReMIND-system consists of:
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Older adults with MCI | Active comparator | Not described Receives: Other: socially assistive robot |
| Caregivers | Active comparator | Not described Receives: Other: socially assistive robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: baseline, month 6
Secondary outcomes (3)
Change from baseline Physical functioning at month 6
Physical functioning will be assessed using the Short Physical Performance Battery (SPPB). A summary score of 0 to 12 (higher score indicating better function) is based on performance on three tasks: gait speed, chair rise, and three standing positions.
Measured: baseline, month 6
Change from baseline Cognitive functioning at month 6
The Montreal Cognitive Assessment (MoCA) will be applied to measure cognitive functioning. Scores range between 0-30, with a higher score indicating a better cognitive functioning.
Measured: baseline, month 6
Change from baseline Participation level at month 6
Single-item measures were created to question the participant's level of participation. Participants have to indicate on a scale from 0-10 to what extent they agree with the propositions.
Measured: baseline, month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start12 Oct 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848155
- Sponsor's protocol ID
- B6702020000244
- Status last verified
- Nov 2022
- First submitted
- 19 Mar 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of Socially Assistive Robot on Older Adults With MCI and Their Caregivers
- ClinicalTrials.gov ID
- NCT04848155
- Acronym / sponsor ID
- B6702020000244
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of the current study is to evaluate the impact of the robot using a cross-over design.
- Recruitment An existing database with facilities, built up in the previous phases of the project, will be used to recruit new participants. Sample Size calculations were done a priori using G*Power, based on an effect size of 0.4 and testing the difference between two dependent means. According to these calculations, a total sample size of 62 would allow us to detect significant differences among the mean values on the primary outcome measures (α =.025 and power =.8).
- Handling Missing Data Since the reason for dropouts might be of great importance for the results of this study, they will be taken into account. Therefore, the Intention To Treat (ITT) approach will be applied.
- Data Analysis
- Quantitative Analysis
Descriptive statistics will be employed to describe the characteristics of the participants. Distribution of data will be assessed by inspecting the histograms and by appropriate tests, e.g. Shapiro-Wilk Test. Data will be visualized using bar charts (categorical variables) and/or box plots (continuous variables). If appropriate, independent t-tests will be used at baseline data to investigate whether or not there are significant differences between both groups. Alternatively, in case of non-normal distributed data, Mann Whitney-U tests will be applied instead.
Active Engagement Evaluation will be performed at baseline, after 3 months, 6 months, 9 months and 12 months in the study with both group A and B. Primary endpoint is the comparison "no robot" vs "robot" at 6 months within that period. Active Engagement will be calculated by comparing the data of the intervention and control group after 6 months and 12 months with counts (the number of times the person shows a certain behavior at a certain time point during the activity) as the outcome variable. Data will be analyzed using a mixed negative binominal regression, with the subjects considered the random factor and the following variables as fixed effects: (1) condition (robot vs no robot), (2) time (baseline, 3 and 6 months) and (3) interaction between condition and time.
Loneliness Evaluation will be performed at baseline, after 3 months, 6 months, 9 months and 12 months in the study with both group A and B. Primary endpoint is the comparison "no robot" vs "robot" at 6 months within that period. Loneliness will be calculated by comparing the scores on the (full) loneliness scale of the intervention group and the control group after 6 and 12 months. Data will be analyzed using a mixed linear regression, with "loneliness" as the outcome variable and the following variables as fixed effects: (1) condition (robot vs no robot), (2) time (baseline, 3 and 6 months) and (3) interaction between condition and time. The subjects in the study are considered the random factor.
Secondary outcomes Evaluation will be performed at baseline, after 3 months, 6 months, 9 months and 12 months in the study with both group A and B. Primary endpoint is the comparison "no robot" vs "robot" at 6 months within that period. For analyzing the data of the secondary outcomes (physical functioning, cognitive functioning and participation), a linear mixed model will be used (similar to the primary outcomes) if data is distributed normally.
Since multiple comparisons are made, a Bonferroni correction will be applied. The Bonferroni-corrected level of statistical significance will be set at α = .025. Data analyses will be conducted by SPSS Statistics software. For the secondary outcomes, statistical significance will be set at a level of p<.05.
2 - Qualitative Analysis
Focus groups will be conducted after 6 and 12 months to receive feedback from the caregivers. Inductive thematic analysis will be used to analyze the data from the focus groups. This will be done according to the guideline designed by Braun and Clarke (2006), which describes different phases in the process of conducting thematic analysis. In the first phase, the researcher becomes familiarized with the data by a thorough (re)reading from the data from the focus groups. Initial ideas that could possibly be of value will be noted down. The second phase consists of the coding process, where interesting features in the data are being labeled and initial codes will be produced. An interpretative analysis of the data occurs and similarities in the codes will be identified, generating potential themes. These themes will be discussed within the research team and further refined in the next phase, where clear definitions and names will be generated. The analysis will be carried out by the corresponding researcher from each test-site. This in order to enable a focus on the different perspectives resulting from the different settings where the study will be conducted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older adults with MCI | Active comparator | Other: socially assistive robot |
| Caregivers | Active comparator | Other: socially assistive robot |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65+
- Score range of 19/30 - 25/30 on Montreal Cognitive Assessment (MoCA)
- Ability to walk independently with or without assistive device
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| socially assistive robotThe 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. | Other | Caregivers, Older adults with MCI |
Primary outcome
Change from baseline Active Engagement at month 6
Time frame: baseline, 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).
Change from baseline Loneliness at month 6
Time frame: baseline, 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.
3 secondary outcomes
Change from baseline Physical functioning at month 6
Time frame: baseline, month 6
Change from baseline Cognitive functioning at month 6
Time frame: baseline, month 6
Change from baseline Participation level at month 6
Time frame: baseline, month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing socially assistive robot in people with Mild Cognitive Impairment, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Active Engagement at month 6 (time frame: baseline, month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.