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Clinical Trials/NCT06683443
NCT06683443
Completed
Not Applicable

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

Sarasota Memorial Health Care System1 site in 1 country106 target enrollmentJanuary 2, 2024

Overview

Phase
Not Applicable
Intervention
Robotic Joy for All™ pet
Conditions
Dementia
Sponsor
Sarasota Memorial Health Care System
Enrollment
106
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
last month

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
January 2, 2024
End Date
December 29, 2025
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sarasota Memorial Health Care System
Responsible Party
Principal Investigator
Principal Investigator

Joanna D'Elia

Adv Specialty Program Coord, Clinical Specialty Programs

Sarasota Memorial Health Care System

Eligibility Criteria

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

Arms & Interventions

Robotic Pet

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

Intervention: Robotic Joy for All™ pet

Control

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

Outcomes

Primary Outcomes

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.

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.

The use of intravenous psychotropic medications.

Time Frame: 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.

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

Hospital length of stay.

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

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

The use of restraints.

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

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

Occurrence of falls.

Time Frame: 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.

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

"Code Greys"

Time Frame: 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.

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

Intravenous catheter dislodgement occurrences.

Time Frame: 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.

Patient's will be monitored for intravenous catheter dislodgements.

Delirium order set.

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

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

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

Time Frame: 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.

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.

Blood Pressure

Time Frame: 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.

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.

Heart Rate

Time Frame: 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.

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

Pain Signs

Time Frame: 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.

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.

Secondary Outcomes

  • 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.(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..)

Study Sites (1)

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