Assessing the Effects of Robotic Pets on Patients With Dementia in the Acute Care Hospital Setting

NCT ID: NCT06683443

Last Updated: 2025-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Robotic pets can provide a source of affection and companionship for patients. This is especially important as individuals with dementia may receive infrequent visitation from family members if their families struggle with how to cope and communicate with their loved one. Several options such as the "Joy for All™" and "Paro" robotic pets offer a source of companionship that is both interactive and comforting.

Sarasota Memorial Health Care System (SMHCS) researchers are seeking to make companion pets available to patients with dementia to provide them with a supplemental enrichment experience that enhances their overall care and lowers their risk for superimposed delirium. The intervention will consist of providing a robotic pet to the patient within 48 hours of admission, which the patient will keep with them throughout their hospital stay and upon discharge. SMHCS researchers will evaluate the effects of the robotic pet interaction on patient delirium scores, as measured by the Nursing Delirium Screening Scale (Nu-DESC), length of stay, and the use of intravenous psychotropic medications, code greys, falls occurrence, restraint use, and IV dislodgement in patients with mild-to-moderate dementia. The Nu-DESC scale is a short assessment tool, estimated to take approximately 3-5 minutes to complete and is already part of standard care at SMHCS. This tool is used by nursing staff with minimal additional training and shows consistent sensitivity (85.7%) and specificity (86.8%) in detecting delirium. The NuDESC score may be positive in a patient with dementia, since some characteristics of dementia can be similar to delirium. However, patients with dementia are at higher risk for developing delirium, so the NuDESC is a helpful tool for the nurse. A score of 2 or higher is considered screening positive for delirium. For this study, the NuDESC tool will be used as a guideline to assist in the screening of delirium. The patients will have to score a 4 or less to be included in the study. Patients that are scoring \>4 will be excluded. Theoretic Framework of Acceptability (TFA) is a questionnaire which will be used to assess health care provider acceptability of the companion animal. This tool is currently not in use at SMHCS, but it will be used as part of this study to assess whether health care providers accept (or reject) the robotic pets as companion animals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dementia Delirium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A total of 106 patients, ages 65 years or older, with dementia who are admitted to the designated medical-surgical units at SMHCS will be enrolled in the study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robotic Pet

The intervention group will receive the robotic Joy for All™ pet.

Group Type EXPERIMENTAL

Robotic Joy for All™ pet

Intervention Type BEHAVIORAL

Patients will be provided with the robotic pet within 48 hours of admission and have access to the pets throughout their hospitalization to provide comfort and engagement.

Control

Control group will receive the current standard of care, no robotic pet.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robotic Joy for All™ pet

Patients will be provided with the robotic pet within 48 hours of admission and have access to the pets throughout their hospitalization to provide comfort and engagement.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with:

* Dementia indicated in the patient's chart
* Admitted to the designated medical-surgical units at Sarasota Memorial Health Care System
* Ages 65 and older
* NuDESC score will be 0-4 during study enrollment.

Exclusion Criteria

* Patients who are:

* \<65 years old
* NuDESC score \>4 during study enrollment
* Patients at risk for alcohol withdrawal or substance abuse withdrawal
* Enhanced isolation precautions (c.diff)
* Presenting with paranoia, hallucinations, or severe agitation
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sarasota Memorial Health Care System

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joanna D'Elia

Adv Specialty Program Coord, Clinical Specialty Programs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joanna D'Elia, MSN, RN, GERO-BC

Role: PRINCIPAL_INVESTIGATOR

Sarasota Memorial Health Care System

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Heidenreich, A. & Gresbach, S. (2018). The "Nu" way for nurses to screen for delirium. American Nurse Today, 13(5). 52-54.

Reference Type BACKGROUND

Hudson J, Ungar R, Albright L, Tkatch R, Schaeffer J, Wicker ER. Robotic Pet Use Among Community-Dwelling Older Adults. J Gerontol B Psychol Sci Soc Sci. 2020 Oct 16;75(9):2018-2028. doi: 10.1093/geronb/gbaa119.

Reference Type BACKGROUND
PMID: 32789476 (View on PubMed)

Morandi A, Bellelli G. Delirium superimposed on dementia. Eur Geriatr Med. 2020 Feb;11(1):53-62. doi: 10.1007/s41999-019-00261-6. Epub 2019 Nov 14.

Reference Type BACKGROUND
PMID: 32297232 (View on PubMed)

Morley JE. Dementia-related agitation. J Am Med Dir Assoc. 2011 Nov;12(9):611-612.e2. doi: 10.1016/j.jamda.2011.08.008. Epub 2011 Oct 5. No abstract available.

Reference Type BACKGROUND
PMID: 21975343 (View on PubMed)

Moyle W, Bramble M, Jones C, Murfield J. Care staff perceptions of a social robot called Paro and a look-alike Plush Toy: a descriptive qualitative approach. Aging Ment Health. 2018 Mar;22(3):330-335. doi: 10.1080/13607863.2016.1262820. Epub 2016 Dec 14.

Reference Type BACKGROUND
PMID: 27967207 (View on PubMed)

Moyle W, Bramble M, Jones CJ, Murfield JE. "She Had a Smile on Her Face as Wide as the Great Australian Bite": A Qualitative Examination of Family Perceptions of a Therapeutic Robot and a Plush Toy. Gerontologist. 2019 Jan 9;59(1):177-185. doi: 10.1093/geront/gnx180.

Reference Type BACKGROUND
PMID: 29165558 (View on PubMed)

Moyle W, Murfield J, Jones C, Beattie E, Draper B, Ownsworth T. Can lifelike baby dolls reduce symptoms of anxiety, agitation, or aggression for people with dementia in long-term care? Findings from a pilot randomised controlled trial. Aging Ment Health. 2019 Oct;23(10):1442-1450. doi: 10.1080/13607863.2018.1498447. Epub 2018 Nov 24.

Reference Type BACKGROUND
PMID: 30474401 (View on PubMed)

Petersen S, Houston S, Qin H, Tague C, Studley J. The Utilization of Robotic Pets in Dementia Care. J Alzheimers Dis. 2017;55(2):569-574. doi: 10.3233/JAD-160703.

Reference Type BACKGROUND
PMID: 27716673 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://doi.org/10.7748/nop.35.2.6.s2

Delirium: when to be worried about confusion and what to do next: Update for nurses on timely assessment of this common condition in acute settings and long-term care, and why it should be treated as a medical emergency. Nursing Older People, 35(2), 6-8.

https://doi.org/10.1016/S1474-4422(15)00101-5

The interface between delirium and dementia in elderly adults. The Lancet Neurology, 14(8), 823-832.

http://www.parorobots.com/

PARO Therapeutic Robot

https://www.ncbi.nlm.nih.gov/books/NBK470399/

Delirium. \[Updated 2022 Nov 19\].

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23-MEDI-96

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Rural Dementia Caregiver Project
NCT04428112 COMPLETED NA