NCT06246734

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

March 3, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

January 30, 2024

Last Update Submit

January 7, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Other Outcomes (1)

  • Engagement with Pet

    Follow-up interview, 6-8 weeks after baseline

Study Arms (2)

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.

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.

Interventions

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.

Treatment, Immediate Robot Pet Companion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Uncomfortable with robot pet companion in home
  • Family Caregiver \< 18 years age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

DementiaSocial BehaviorCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehaviorStress, PsychologicalBehavioral Symptoms

Study Officials

  • Steven M Albert, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor blind to treatment allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

March 3, 2024

Primary Completion

October 31, 2024

Study Completion

December 31, 2024

Last Updated

January 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Following study completion for 12 months
Access Criteria
Email: smalbert@pitt.edu

Locations