DementiaNCT06246734
Companion Robotic Pets and Older Adults
A study testing Hasbro Joy for All robot pet companion in people with Dementia and Social Behavior, run by University of Pittsburgh at 1 site in United States.
Trial summary
This research will assess the effect of companion robotic pets on the wellbeing of older adults and their family caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Social Behavior, Caregiver Burden
- What is being tested?
- Hasbro Joy for All robot pet companion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2024to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participating in Family Caregiver Support Program or OPTIONS Program administered by Allegheny County Area Agency on Aging
- Provide unpaid family or friend caregiver support for at least 6 months
- Older person aged 50+
- Able to provide verbal informed consent
Who cannot join
- Uncomfortable with robot pet companion in home
- Family Caregiver < 18 years age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Effect of Companion Robotic Pets on Older Adult Well-Being
This research will assess the effect of companion robotic pets on the wellbeing of older adults and their family caregivers.
Read the detailed description
Social robot pets have been shown to have a positive impact on age-related physical, cognitive, emotional, and social challenges that affect independence and quality of life. These "pets" are designed to interact with people as a real pet might. They purr when stroked, make eye contact, have a heartbeat, turn toward a person when touched, are warm, and appear lifelike. Does introduction of such a pet reduce loneliness or promote engagement in older adults with cognitive or physical disability?
This research will determine if:
- Older adults with disabilities engage with such robotic companions;
- Placing a robotic pet in a home enhances mood and positive affect in older people;
- Caregivers to these adults find the robots beneficial for their own mood and time use.
In a single-blind randomized controlled trial over 6-8 weeks, we hypothesize that older adults in the intervention arm will engage with the pets and show benefit in mood as reported by family caregivers.
- Conditions
- Dementia, Social Behavior, Caregiver Burden
- Being tested
- Hasbro Joy for All robot pet companion
- Medical subject headings
- Dementia, Social Behavior, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hasbro Joy for All robot pet companionBehavioural
The robot pets are stuffed animals (dogs and cats) that have features that make them seem lifelike. For example, the animal toys turn their heads when petted, purr or make puppy sounds, feel warm, have a heartbeat, and go to sleep when they are ignored. They respond to attention and petting like a real pet. The robot pets do not collect information and do not require any maintenance, except a battery. Engagement with the device is at the discretion of participants.
| Study group | Role | What they receive |
|---|---|---|
| Treatment, Immediate Robot Pet Companion | Experimental | Participants will receive a Hasbro Joy for All robotic pet. These are low cost (< $150), life-like cats and dogs that respond to human interaction by making sounds or turning their head for eye contact. The robot companion pets are designed as supports for older people with cognitive impairment. In this trial, the older person can treat it like a pet or ignore it. Family caregivers will report on engagement with the pet and effects on mood. Receives: Behavioral: Hasbro Joy for All robot pet companion |
| Control, Delayed Robot Pet Companion | No intervention | During the 6-8 week trial, this group will not receive the robot pet companion but will complete baseline and follow-up assessments on teh same schedule as the treatment arm. Participants in this arm will receive the robot pet after the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive Affect Scale from Baseline to 6-8 weeks
PROMIS Positive Affect Short Form 15a Scale: The PROMIS measures are normed for population probability samples, with raw scores transformed into T scores (mean 50, SD=10). The scale measures positive emotion (e.g., enjoyment, engagement, serenity).
Measured: Baseline and Follow-up, 6-8 weeks later
Change in Negative Affect from Baseline to 6-8 weeks
PROMIS Emotional Distress and Anger Short Form Scale: The PROMIS measures are normed for population probability samples, with raw scores transformed into T scores (mean = 50, SD=10). The scale measures emotional distress (e.g., irritability, anger).
Measured: Baseline and Follow-up, 6-8 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start3 Mar 2024
- Primary completion31 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Allegheny County Department of Human Services, Area Agency on Aging
- Responsible party
- Principal investigator, Steven M. Albert, University of Pittsburgh
- Investigators
- Steven M Albert, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246734
- Sponsor's protocol ID
- STUDY23090076
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual-level research data will be made available to qualified researchers who submit an analytic plan for IRB-approved research. Only de-identified data will be shared. Also, we will contact Pitt's Office of Sponsored Programs prior to sharing any data outside of the institution.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Companion Robotic Pets on Older Adult Well-Being
- ClinicalTrials.gov ID
- NCT06246734
- Acronym / sponsor ID
- STUDY23090076
- Conditions
- Dementia, Social Behavior, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Allegheny County Department of Human Services, Area Agency on Aging
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 7 Feb 2024 (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.
This research will assess the effect of companion robotic pets on the wellbeing of older adults and their family caregivers.
Detailed description
Social robot pets have been shown to have a positive impact on age-related physical, cognitive, emotional, and social challenges that affect independence and quality of life. These "pets" are designed to interact with people as a real pet might. They purr when stroked, make eye contact, have a heartbeat, turn toward a person when touched, are warm, and appear lifelike. Does introduction of such a pet reduce loneliness or promote engagement in older adults with cognitive or physical disability?
This research will determine if:
- Older adults with disabilities engage with such robotic companions;
- Placing a robotic pet in a home enhances mood and positive affect in older people;
- Caregivers to these adults find the robots beneficial for their own mood and time use.
In a single-blind randomized controlled trial over 6-8 weeks, we hypothesize that older adults in the intervention arm will engage with the pets and show benefit in mood as reported by family caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment, Immediate Robot Pet Companion | Experimental | Behavioral: Hasbro Joy for All robot pet companionParticipants will receive a Hasbro Joy for All robotic pet. These are low cost (< $150), life-like cats and dogs that respond to human interaction by making sounds or turning their head for eye contact. The robot companion pets are designed as supports for older people with cognitive impairment. In this trial, the older person can treat it like a pet or ignore it. Family caregivers will report on engagement with the pet and effects on mood. |
| Control, Delayed Robot Pet Companion | No intervention | –During the 6-8 week trial, this group will not receive the robot pet companion but will complete baseline and follow-up assessments on teh same schedule as the treatment arm. Participants in this arm will receive the robot pet after the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participating in Family Caregiver Support Program or OPTIONS Program administered by Allegheny County Area Agency on Aging
- Provide unpaid family or friend caregiver support for at least 6 months
- Older person aged 50+
- Able to provide verbal informed consent
Key exclusion criteria (2 listed)
- Uncomfortable with robot pet companion in home
- Family Caregiver < 18 years age
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 |
|---|---|---|
| Hasbro Joy for All robot pet companionThe robot pets are stuffed animals (dogs and cats) that have features that make them seem lifelike. For example, the animal toys turn their heads when petted, purr or make puppy sounds, feel warm, have a heartbeat, and go to sleep when they are ignored. They respond to attention and petting like a real pet. The robot pets do not collect information and do not require any maintenance, except a battery. Engagement with the device is at the discretion of participants. | Behavioural | Treatment, Immediate Robot Pet Companion |
Primary outcome
Change in Positive Affect Scale from Baseline to 6-8 weeks
Time frame: Baseline and Follow-up, 6-8 weeks later
PROMIS Positive Affect Short Form 15a Scale: The PROMIS measures are normed for population probability samples, with raw scores transformed into T scores (mean 50, SD=10). The scale measures positive emotion (e.g., enjoyment, engagement, serenity).
Change in Negative Affect from Baseline to 6-8 weeks
Time frame: Baseline and Follow-up, 6-8 weeks later
PROMIS Emotional Distress and Anger Short Form Scale: The PROMIS measures are normed for population probability samples, with raw scores transformed into T scores (mean = 50, SD=10). The scale measures emotional distress (e.g., irritability, anger).
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 9 Jan 2025.
- Individual participant dataSharing planned: Yes. All individual-level research data will be made available to qualified researchers who submit an analytic plan for IRB-approved research. Only de-identified data will be shared. Also, we will contact Pitt's Office of Sponsored Programs prior to sharing any data outside of the institution.
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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.
Steven M Albert, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hasbro Joy for All robot pet companion in people with Dementia and Social Behavior, run by University of Pittsburgh at 1 site 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 4 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 9 Jan 2025. 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 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?
Change in Positive Affect Scale from Baseline to 6-8 weeks (time frame: Baseline and Follow-up, 6-8 weeks later). 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 9 Jan 2025.