Nursing Home ResidentNCT06174337
Robot for Alleviating Loneliness and Engaging Nursing Home Residents
An observational study of Nursing Home Resident, run by Northeastern University at 2 sites in United States.
Trial summary
Social isolation is an emerging critical challenge in the care of older adults. Nursing home residents engage for an average of just 12 minutes per day with an activity director, a situation further exacerbated by Covid-19. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nursing Home Resident
- What is being tested?
- Use of Video Connection with Family via Robot
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jun 2022to 30 Nov 2023
- Phase
- Observational
- 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
- Older adult
Study population: Residents of 2 nursing homes in Massachusetts
Who may be able to join
- Over 65 years of age
- Able to read and speak English
- Recommended by staff or family member
Who cannot join
- Uncorrected vision or auditory impairment
- MoCA < 22
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New Bridge on the Charles
Dedham, Massachusetts, 02026
Maplewood Senior Living
Weston, Massachusetts, 02493
About this study
Official title: Autonomous Navigating Telepresence Robot for Alleviating Loneliness and Engaging Nursing Home Residents With and Without Dementia
Social isolation is an emerging critical challenge in the care of older adults. Nursing home residents engage for an average of just 12 minutes per day with an activity director, a situation further exacerbated by Covid-19. Social isolation has detrimental effects on health, evidenced by 48.7% of nursing home residents with an active depression diagnosis, and 61% have moderate or severe cognitive impairment. The ultimate goal of this project is to alleviate older adults loneliness and boredom and to improve their mood in an economically feasible and scalable way. The investigators will integrate the existing Vigorous Mind (VM) multidomain activities platform for older adults with an affordable autonomous navigating robot to remotely socialize with and engage long-term-care facility (Facility) residents diagnosed with Mild Cognitive Impairment (MCI) or early-stage Alzheimer s disease or related dementias (Residents). The VM web-based platform has been used for group activities in senior living facilities for eight years. A Resident s profile in VM automatically searches the web and presents their favorite music, reminiscence content, comedy, and personalized brain exercises. VM is secure and HIPAA compliant. A VM employee (VM Companion) with experience running activities in a long-term care facility will be introduced by the staff to a Resident as a new companion who will visit the Resident through the robot to keep them company. The temi robot can be instructed to go to room 312 and it will navigate its way to the room. The Resident will be notified that the VM Companion is arriving for a visit, and once in the room, the VM Companion will see and greet the Resident, and the Resident will see the VM Companion. Since the VM Companion has dashboard access to the Resident s background and interests via the VM profile, they will be able to meaningfully socialize and engage in relevant VM activities. The goal of this Phase I project is to test the feasibility of this idea and to collect preliminary data on its effect on loneliness and mood.
Read the detailed description
Background:
Social isolation and loneliness are critical challenges in older adult care. Loneliness is associated with declines in both physical and mental health. Approximately 50% of older adults over the age of 80 years experience loneliness. Nursing home residents are at a greater risk of loneliness due to limited staffing and COVID-19 visiting restrictions in place. More socially active older adults experience less cognitive decline in old age and better overall functioning. The use of technology for social interaction may have a positive impact on the behavioral and psychological symptoms of Alzheimer's disease (AD) especially in early stages of the disease. Robots are currently used in very few senior living facilities and cognitive support and communication are among the most desired functions. By using an autonomous navigating telepresence robot, the intervention brings the technology to the resident and allows her/him to socialize and interact with a loved-one without the need for a caregiver. This intervention integrates the Vigorous Mind system with the temi autonomous navigating telepresence robot (Vigorous Mind Robot - "VMR").
Aims:
- Develop web-based visit scheduler and integrate the VM platform with the temi robot
- Test usability of the VMR with 10 Residents and family members
- Pilot study of the feasibility of a VMR intervention with 40 Residents
Experimental Design:
Testing of the VMR intervention consisted of a usability and feasibility phase. During usability, residents and family members were trained on use of the VMR robot and web-interface. Family members conducted two virtual visits and usability interviews with residents and family members followed each visit. Feasibility followed usability testing with a three-month period where family members were able to schedule virtual visits as often as they would like. Debriefing interviews with family members and residents occurred at the end of feasibility testing. Resident loneliness and mood was assessed with the UCLA Loneliness Scale, Geriatric Depression Scale, single-item loneliness scale, and PHQ-2.
- Conditions
- Nursing Home Resident
- Being tested
- Use of Video Connection with Family via Robot
- Keywords
- Robot, Loneliness, Nursing Home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Video Connection with Family via RobotBehavioural
A remote family member is able to connect via video with a nursing home resident.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall experience with the robot - for the family
5 point Likert scale from maximum of "very good" to minimum of "very poor"
Measured: 3 months
Overall experience with the robot for the resident
5 point Likert scale from maximum of "very good" to minimum of "very poor"
Measured: 3 months
Ease of use of the robot for the family
5 point Likert scale from maximum of "very good" to minimum of "very poor"
Measured: 3 months
Ease of use of the robot for the resident
5 point Likert scale from maximum of "very good" to minimum of "very poor"
Measured: 3 months
Secondary outcomes (2)
Change in Loneliness of resident
5 point rating from minimum of "seldom/never" to maximum of "always/often"; change over 3 months
Measured: 3 months
Change in depression level of resident
Change in PHQ-2 score over 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start21 Jun 2022
- Primary completion1 Aug 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing Home ResidentStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Vigorous Mind, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174337
- Sponsor's protocol ID
- 1R43AG073004-01
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomous Navigating Telepresence Robot for Alleviating Loneliness and Engaging Nursing Home Residents With and Without Dementia
- ClinicalTrials.gov ID
- NCT06174337
- Acronym / sponsor ID
- 1R43AG073004-01
- Conditions
- Nursing Home Resident
- Keywords
- Robot, Loneliness, Nursing Home
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- Vigorous Mind, Inc.
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 18 Dec 2023 (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.
Social isolation is an emerging critical challenge in the care of older adults. Nursing home residents engage for an average of just 12 minutes per day with an activity director, a situation further exacerbated by Covid-19. Social isolation has detrimental effects on health, evidenced by 48.7% of nursing home residents with an active depression diagnosis, and 61% have moderate or severe cognitive impairment. The ultimate goal of this project is to alleviate older adults loneliness and boredom and to improve their mood in an economically feasible and scalable way. The investigators will integrate the existing Vigorous Mind (VM) multidomain activities platform for older adults with an affordable autonomous navigating robot to remotely socialize with and engage long-term-care facility (Facility) residents diagnosed with Mild Cognitive Impairment (MCI) or early-stage Alzheimer s disease or related dementias (Residents). The VM web-based platform has been used for group activities in senior living facilities for eight years. A Resident s profile in VM automatically searches the web and presents their favorite music, reminiscence content, comedy, and personalized brain exercises. VM is secure and HIPAA compliant. A VM employee (VM Companion) with experience running activities in a long-term care facility will be introduced by the staff to a Resident as a new companion who will visit the Resident through the robot to keep them company. The temi robot can be instructed to go to room 312 and it will navigate its way to the room. The Resident will be notified that the VM Companion is arriving for a visit, and once in the room, the VM Companion will see and greet the Resident, and the Resident will see the VM Companion. Since the VM Companion has dashboard access to the Resident s background and interests via the VM profile, they will be able to meaningfully socialize and engage in relevant VM activities. The goal of this Phase I project is to test the feasibility of this idea and to collect preliminary data on its effect on loneliness and mood.
Detailed description
Background:
Social isolation and loneliness are critical challenges in older adult care. Loneliness is associated with declines in both physical and mental health. Approximately 50% of older adults over the age of 80 years experience loneliness. Nursing home residents are at a greater risk of loneliness due to limited staffing and COVID-19 visiting restrictions in place. More socially active older adults experience less cognitive decline in old age and better overall functioning. The use of technology for social interaction may have a positive impact on the behavioral and psychological symptoms of Alzheimer's disease (AD) especially in early stages of the disease. Robots are currently used in very few senior living facilities and cognitive support and communication are among the most desired functions. By using an autonomous navigating telepresence robot, the intervention brings the technology to the resident and allows her/him to socialize and interact with a loved-one without the need for a caregiver. This intervention integrates the Vigorous Mind system with the temi autonomous navigating telepresence robot (Vigorous Mind Robot - "VMR").
Aims:
- Develop web-based visit scheduler and integrate the VM platform with the temi robot
- Test usability of the VMR with 10 Residents and family members
- Pilot study of the feasibility of a VMR intervention with 40 Residents
Experimental Design:
Testing of the VMR intervention consisted of a usability and feasibility phase. During usability, residents and family members were trained on use of the VMR robot and web-interface. Family members conducted two virtual visits and usability interviews with residents and family members followed each visit. Feasibility followed usability testing with a three-month period where family members were able to schedule virtual visits as often as they would like. Debriefing interviews with family members and residents occurred at the end of feasibility testing. Resident loneliness and mood was assessed with the UCLA Loneliness Scale, Geriatric Depression Scale, single-item loneliness scale, and PHQ-2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Residents of 2 nursing homes in Massachusetts
Key inclusion criteria (3 listed)
- Over 65 years of age
- Able to read and speak English
- Recommended by staff or family member
Key exclusion criteria (2 listed)
- Uncorrected vision or auditory impairment
- MoCA < 22
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 |
|---|---|---|
| Use of Video Connection with Family via RobotA remote family member is able to connect via video with a nursing home resident. | Behavioural | – |
Primary outcome
Overall experience with the robot - for the family
Time frame: 3 months
5 point Likert scale from maximum of "very good" to minimum of "very poor"
Overall experience with the robot for the resident
Time frame: 3 months
5 point Likert scale from maximum of "very good" to minimum of "very poor"
Ease of use of the robot for the family
Time frame: 3 months
5 point Likert scale from maximum of "very good" to minimum of "very poor"
Ease of use of the robot for the resident
Time frame: 3 months
5 point Likert scale from maximum of "very good" to minimum of "very poor"
2 secondary outcomes
Change in Loneliness of resident
Time frame: 3 months
Change in depression level of resident
Time frame: 3 months
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 18 Dec 2023.
- Individual participant dataSharing planned: No
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Sustainable Improvement of INTERprofessional Care for Better Resident Outcomes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nursing Home Resident, run by Northeastern University at 2 sites in United States.
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 2 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 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Overall experience with the robot - for the family (time frame: 3 months). The study lists 4 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 18 Dec 2023.