Clinical trial NCT06683443: Assessing the Effects of Robotic Pets on Patients With Dementia in the Acute Care Hospital Setting
Official title: Assessing the Effects of Robotic Pets on Patients With Dementia in the Acute Care Hospital Setting
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dementia
Delirium
Keywords: dementia
memory impairment
delirium
Lead sponsor: Sarasota Memorial Health Care System
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 106
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
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.
timeFrame: 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..
measure: The use of intravenous psychotropic medications.
timeFrame: 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.
measure: Hospital length of stay.
timeFrame: Length of stay is measured from time of admission to time of discharge up to 60 days.
measure: The use of restraints.
timeFrame: Use of restraints will be recorded starting from the time the "robotic pet order" is placed until patient is discharged up to 60 days.
measure: Occurrence of falls.
timeFrame: 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.
measure: "Code Greys"
timeFrame: 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..
measure: Intravenous catheter dislodgement occurrences.
timeFrame: 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.
measure: Delirium order set.
timeFrame: Delirium and worsening of condition will be recorded at time of observation during hospitalization stay up to 60 days..
measure: Use of patient safety attendants (order and length of use)
timeFrame: 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..
Secondary outcomes:
measure: 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.
timeFrame: 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..
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System
state: Florida
Study officials:
affiliation: Sarasota Memorial Health Care System
name: Joanna D'Elia, MSN, RN, GERO-BC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heidenreich, A. & Gresbach, S. (2018). The "Nu" way for nurses to screen for delirium. American Nurse Today, 13(5). 52-54.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.