- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06246734
Companion Robotic Pets and Older Adults
Effect of Companion Robotic Pets on Older Adult Well-Being
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15261
- University of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Uncomfortable with robot pet companion in home
- Family Caregiver < 18 years age
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment, Immediate Robot Pet Companion
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.
|
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.
|
|
No Intervention: Control, Delayed Robot Pet Companion
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline and Follow-up, 6-8 weeks later
|
|
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).
|
Baseline and Follow-up, 6-8 weeks later
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Engagement with Pet
Time Frame: Follow-up interview, 6-8 weeks after baseline
|
Adapted companion animal questionnaire, treatment arm.
The scale measures daily involvement with a pet, such as the frequency of holding the animal, sleeping in the same room, feeling responsible for the animal).
Scale scores range from 6-30.
|
Follow-up interview, 6-8 weeks after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steven M Albert, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY23090076
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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