Companion Robotic Pets and Older Adults

Dementia Clinical Trial

Official title:

Effect of Companion Robotic Pets on Older Adult Well-Being

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246734
• Other study ID #: STUDY23090076
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: Steven M Albert, PhD
• Phone: 412-383-8693
• Email: smalbert[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research will assess the effect of companion robotic pets on the wellbeing of older adults and their family caregivers.

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: 1. Older adults with disabilities engage with such robotic companions; 2. Placing a robotic pet in a home enhances mood and positive affect in older people; 3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participating in Family Caregiver Support Program or OPTIONS Program administered by Allegheny County Area Agency on Aging

2. Provide unpaid family or friend caregiver support for at least 6 months

3. Older person aged 50+

4. Able to provide verbal informed consent

Exclusion Criteria:

1. Uncomfortable with robot pet companion in home

2. Family Caregiver < 18 years age

Related Conditions & MeSH terms

• Caregiver Burden
• Dementia
• Social Behavior

Intervention

Behavioral:
• Hasbro Joy for All robot pet companion
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Allegheny County Department of Human Services, Area Agency on Aging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Engagement with Pet	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
Primary	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).	Baseline and Follow-up, 6-8 weeks later
Primary	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).	Baseline and Follow-up, 6-8 weeks later