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DementiaNCT06683443

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

A study testing Robotic Joy for All™ pet in people with Dementia and Delirium, run by Sarasota Memorial Health Care System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Dementia, Delirium
What is being tested?
Robotic Joy for All™ pet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteUnited States
Study dates
2 Jan 2024to 29 Dec 2025
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34239

Other trials in United States

About this study

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.

Conditions
Dementia, Delirium
Being tested
Robotic Joy for All™ pet
Keywords
dementia, memory impairment, delirium
Medical subject headings
Dementia, Delirium, Memory Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic Joy for All™ petBehavioural

    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.

Study groups in NCT06683443
Study groupRoleWhat they receive
Robotic PetExperimentalThe intervention group will receive the robotic Joy for All™ pet.
Receives: Behavioral: Robotic Joy for All™ pet
ControlNo interventionControl group will receive the current standard of care, no robotic pet.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess how the use of the Joy for All™ companion pet, as compared to standard care, impacts the development or progression of acute delirium in patients with dementia in an acute care setting.

    Delirium, measured by the Nursing Delirium Screening (Nu-DESC) scale, will be compared between intervention group and control group. The NUDESC score ranges from 0-10.

    Measured: Measured at shift change (12 hours intervals), or any time a change in mental status is observed. This will be assessed from the time the "robotic pet order" is placed until discharge up to 60 days.

  2. The use of intravenous psychotropic medications.

    The use of intravenous psychotropic medications (i.e. Haldol, Ativan, etc.) in patients with dementia will be compared between groups.

    Measured: Recorded any time intravenous psychotropic medication is administered starting from the time the "robotic pet order" is placed until patient is discharge up to 60 days.

  3. Hospital length of stay.

    Hospital length of stay will be evaluated between the intervention group and the control group.

    Measured: Length of stay is measured from time of admission to time of discharge up to 60 days.

  4. The use of restraints.

    The use of restraints will be compared intervention group and control group.

    Measured: Use of restraints will be recorded starting from the time the "robotic pet order" is placed until patient is discharged up to 60 days.

  5. Occurrence of falls.

    The number of falls patients have during their hospital stay will be compared between the intervention group and control group.

    Measured: Any fall that occurs during an enrolled patient's hospital stay will be recorded starting from the time the "robotic pet order" is placed until patient is discharged up to 60 days.

  6. "Code Greys"

    The number of "Code Greys" called will be recorded and compared between groups.

    Measured: During the length of the patient's hospitalization, any "Code Grey" will be recorded at time of occurrence starting from the time the "robotic pet order" is placed until patient is discharged up to 60 days.

  7. Intravenous catheter dislodgement occurrences.

    Patient's will be monitored for intravenous catheter dislodgements.

    Measured: All enrolled patients will have any intravenous catheter dislodgment recorded at time of occurrence. This will be recorded starting from the time the "robotic pet order" is placed until patient is discharged, up to 60 days.

  8. Delirium order set.

    Any worsening of condition, evidence of delirium, or delirium order set will be monitored and recorded.

    Measured: Delirium and worsening of condition will be recorded at time of observation during hospitalization stay up to 60 days.

  9. Use of patient safety attendants (order and length of use)

    The group receiving the Joy for All companion pet use of patient safety attendants and/or use of cameras will be compared to the controls group use of patient safety attendants and/or cameras. Number of uses and time of use will be recorded.

    Measured: Patient safety attendant use and camera use will be recorded for use and length of time for each patient enrolled in the study starting from the time the "robotic pet order" is placed until patient is discharged up to 60 days.

  10. Blood Pressure

    Assess how the use of the Joy for All™ companion pet, as compared to standard care, impacts systolic and diastolic blood pressure in patients with mild-to-moderate dementia in an acute care setting.

    Measured: Blood pressure measurements will be collected and monitored during the time the patient is admitted following standard of care procedure, from the time the "robotic pet order", and continue until patient is discharge, up to 60 days.

  11. Heart Rate

    Assess how the use of the Joy for All™ companion pet, as compared to standard care, impacts heart rates in patients with mild-to-moderate dementia in an acute care setting

    Measured: Heart rate measurements will be collected and monitored during the time the patient is admitted following standard of care procedure, from the time the "robotic pet order" is placed, and continue until patient is discharge, up to 60 days.

  12. Pain Signs

    Assess how the use of the Joy for All™ companion pet, as compared to standard care, impacts pain signs in patients with mild-to-moderate dementia in an acute care setting, using a 0-10 Likert scale for pain assessment.

    Measured: Signs of pain will be collected and monitored during the time the patient is admitted following standard of care procedure, from the time the "robotic pet order" is placed, and continue until patient is discharge, up to 60 days.

Secondary outcomes (1)
  1. Determine the registered nurses acceptability of the Joy for All™ companion pet as a form of complementary therapy for patients with dementia in the acute setting.

    Registered nurses will report Joy for All™ companion pets as an acceptable form of complementary therapy for patients with dementia as measured by the Theoretic Framework of Acceptability (TFA) Questionnaire.

    Measured: Flyers will be provided to nurse leadership, charge nurses and in unit common areas (e.g., breakroom) 1-2 times a month for them to take the survey. Emails will also be sent out with the link to take the survey up to 2 years..

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start2 Jan 2024
  3. Primary completion29 Dec 2025
  4. Study completion29 Dec 2025

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06683443
Sponsor's protocol ID
23-MEDI-96
Status last verified
Oct 2025
First submitted
19 Jul 2024
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • 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.

    PubMed 32789476
  • 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.

    PubMed 32297232
  • 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.

    PubMed 21975343
  • 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.

    PubMed 27967207
  • 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.

    PubMed 29165558
  • 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.

    PubMed 30474401
  • 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.

    PubMed 27716673

Questions about this trial

What is this clinical trial studying?

A study testing Robotic Joy for All™ pet in people with Dementia and Delirium, run by Sarasota Memorial Health Care System 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 5 inclusion and 6 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 17 Mar 2026. 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?

Assess how the use of the Joy for All™ companion pet, as compared to standard care, impacts the development or progression of acute delirium in patients with dementia in an acute care setting. (time frame: Measured at shift change (12 hours intervals), or any time a change in mental status is observed. This will be assessed from the time the "robotic pet order" is placed until discharge up to 60 days.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06683443, which also lists 8 linked publications.

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 17 Mar 2026.

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