The Use of PARO to Decrease Agitation in Persons With Dementia and/or Delirium

NCT05565703 | Completed

• 1 other identifier: 833696
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This Clinical trial tests the efficacy of using the PARO robotic seal to decrease agitation in hospitalized older adults with dementia and/or delirium. This clinical trial also tests the efficacy of the cleaning protocol for the robot. This randomized control trial includes a one hour interaction with the PARO robot two days in a row compared to an attention control with the researcher sitting with the participant in their room for one hour two days in a row. The outcomes being evaluated include both qualitative and quantitative data. Qualitative data from videotaped interactions with the persons interacting with the PARO Robot include episodes of agitation, and emotional responses to the robot via facial expressions. The quantitative outcomes include the Agitation, use of 1:1 sitters, use of psychoactive medications and length of stay.

Conditions

Dementia; Delirium

Keywords

Robotics; Nursing; nonpharmacological interventions

Outcome Measures

Primary Outcomes (21)

• Cohen-Mansfield agitation inventory observational

  a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.

  Day 1 this tool is assessed at baseline

• Cohen-Mansfield agitation inventory observational

  a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.

  Day 2 this tool is assessed at baseline

• Cohen-Mansfield agitation inventory observational

  a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.

  Day 1 this tool is assessed again 20 minutes post baseline assessment

• Cohen-Mansfield agitation inventory observational

  a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.

  Day 2 this tool is assessed again 20 minutes post baseline assessment

• Cohen-Mansfield agitation inventory observational

  a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.

  Day 1 this tool is assessed 40 minutes post baseline assessment

• Cohen-Mansfield agitation inventory observational

  a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.

  Day 2 this tool is assessed 40 minutes post baseline assessment

• Cohen-Mansfield agitation inventory observational

  a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.

  Day 1 this tool is assessed at 60 minutes post baseline

• Cohen-Mansfield agitation inventory observational

  a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.

  Day 2 this tool is assessed at 60 minutes post baseline

• Cohen-Mansfield agitation inventory observational

  a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.

  Day 1 this tool is assessed at 70 minutes after the baseline

• Cohen-Mansfield agitation inventory observational

  a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.

  Day 2 this tool is assessed at 70 minutes after the baseline

• Pain in Dementia Scale

  This is another observational scale that identifies behaviors consistent with pain in persons with dementia. The scores range from 0 to 10 with higher scores indicating more pain.

  Day 1 this tool is assessed at baseline

• Pain in Dementia Scale

  This is another observational scale that identifies behaviors consistent with pain in persons with dementia. The scores range from 0 to 10 with higher scores indicating more pain.

  Day 2 this tool is assessed at baseline

• Pain in Dementia Scale

  This is another observational scale that identifies behaviors consistent with pain in persons with dementia. The scores range from 0 to 10 with higher scores indicating more pain.

  Day 1 and 2 this tool is assessed again 20 minutes post baseline assessment

• Pain in Dementia Scale

  This is another observational scale that identifies behaviors consistent with pain in persons with dementia. The scores range from 0 to 10 with higher scores indicating more pain.

  Day 1 this tool is assessed again 20 minutes post baseline assessment

• Pain in Dementia Scale

  This is another observational scale that identifies behaviors consistent with pain in persons with dementia. The scores range from 0 to 10 with higher scores indicating more pain.

  Day 2 this tool is assessed 40 minutes post baseline assessment

• Pain in Dementia Scale

  This is another observational scale that identifies behaviors consistent with pain in persons with dementia. The scores range from 0 to 10 with higher scores indicating more pain.

  Day 1 this tool is assessed at 60 minutes post baseline

• Pain in Dementia Scale

  This is another observational scale that identifies behaviors consistent with pain in persons with dementia. The scores range from 0 to 10 with higher scores indicating more pain.

  Day 2 this tool is assessed at 60 minutes post baseline

• Pain in Dementia Scale

  This is another observational scale that identifies behaviors consistent with pain in persons with dementia. The scores range from 0 to 10 with higher scores indicating more pain.

  Day 1 this tool is assessed at 70 minutes post the baseline

• Pain in Dementia Scale

  This is another observational scale that identifies behaviors consistent with pain in persons with dementia. The scores range from 0 to 10 with higher scores indicating more pain.

  Day 2 this tool is assessed at 70 minutes post the baseline

• Social Interaction Tool

  This observational tool captures the interactions between the participant and the robot during the 60 minute intervention

  Day 1 this tool is completed at the end of the 60 minute interaction with the PARO robot

• Social Interaction Tool

  This observational tool captures the interactions between the participant and the robot during the 60 minute intervention

  Day 2 this tool is completed at the end of the 60 minute interaction with the PARO robot

Secondary Outcomes (4)

• Number of 1:1 sitter hours

  Within 6 weeks of the participant's discharge a report is reviewed online to determine the number of hours this person had a sitter while in the hospital

• Number of psychoactive medications

  The medications are recorded within 2 hours of the Participant's Day 1 and Day 2

• Length of stay

  Within 6 weeks of the participant's discharge the number of days are retrieved from the participant electronic records

• Emotional response to the robot

  Within one year of the participants engagement with the study the videotapes are reviewed and coded.

Study Arms (2)

Intervention Group

EXPERIMENTAL

This group is randomly selected from the Acute care for elders unit and receives a one hour intervention with the PARO robotic seal two days in a row during their hospital stay.

Other: PARO Robotic Seal Intervention

Attention Control Group

ACTIVE COMPARATOR

This group is randomly selected from the Acute Care for Elders unit and receives a one hour visit from the Researcher or research assistant two days in a row.

Other: Attention Control

Interventions

PARO Robotic Seal Intervention OTHER

PARO is a therapeutic robot used to comfort PWD exhibiting agitation and restlessness (www.parorobots.com). Participants are brought out to the activity are on the ACE Unit and provided with an isolation gown to wear during their interaction with the seal. The robot is then placed on their laps for them to hold on their laps, pet, rock and pick up. The participants can also brush the robot and/or give it a bath with baby wipes. The researcher encourages participant engagement with the robot. If the participant does not want the robot on their lap it is placed on a bedside table for them to interact with.

Intervention Group

Attention Control OTHER

The participants are randomly assigned and receive a one hour visit by the researcher or research assistant

Attention Control Group

Eligibility Criteria

• Age: 60 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient on the acute Care for Elders unit
• years old or older up to 110 years old
• Have a diagnosis of Alzheimer's Disease and related disorders or delirium during their current hospitalization.
• Have exhibited agitation in the hospitalization based on charge nurse report.
• Responsible party provides consent and the participant assents.
• Willing to wear an isolation gown.

You may not qualify if:

• On isolation
• Has excessive secretions
• Has an open wound
• Does not assent to participate

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (10)

• Cohen-Mansfield J. Conceptualization of agitation: results based on the Cohen-Mansfield Agitation Inventory and the Agitation Behavior Mapping Instrument. Int Psychogeriatr. 1996;8 Suppl 3:309-15; discussion 351-4. doi: 10.1017/s1041610297003530. No abstract available.

  PMID: 9154580 BACKGROUND

• Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. doi: 10.1093/geronj/44.3.m77.

  PMID: 2715584 BACKGROUND

• Cummings J, Mintzer J, Brodaty H, Sano M, Banerjee S, Devanand DP, Gauthier S, Howard R, Lanctot K, Lyketsos CG, Peskind E, Porsteinsson AP, Reich E, Sampaio C, Steffens D, Wortmann M, Zhong K; International Psychogeriatric Association. Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clinical and research definition. Int Psychogeriatr. 2015 Jan;27(1):7-17. doi: 10.1017/S1041610214001963. Epub 2014 Oct 14.

  PMID: 25311499 BACKGROUND

• Dodds P, Martyn K, Brown M. Infection prevention and control challenges of using a therapeutic robot. Nurs Older People. 2018 Mar 23;30(3):34-40. doi: 10.7748/nop.2018.e994.

  PMID: 29569863 BACKGROUND

• Fick DM, Mion LC. How to try this: Delirium superimposed on dementia. Am J Nurs. 2008 Jan;108(1):52-60; quiz 61. doi: 10.1097/01.NAJ.0000304476.80530.7d.

  PMID: 18156861 BACKGROUND

• Griffiths AW, Albertyn CP, Burnley NL, Creese B, Walwyn R, Holloway I, Safarikova J, Surr CA. Validation of the Cohen-Mansfield Agitation Inventory Observational (CMAI-O) tool. Int Psychogeriatr. 2020 Jan;32(1):75-85. doi: 10.1017/S1041610219000279.

  PMID: 30968783 BACKGROUND

• Herr K, Bursch H, Ersek M, Miller LL, Swafford K. Use of pain-behavioral assessment tools in the nursing home: expert consensus recommendations for practice. J Gerontol Nurs. 2010 Mar;36(3):18-29; quiz 30-1. doi: 10.3928/00989134-20100108-04.

  PMID: 20128526 BACKGROUND

• Horgas A, Miller L. Pain assessment in people with dementia. Am J Nurs. 2008 Jul;108(7):62-70; quiz 71. doi: 10.1097/01.NAJ.0000325648.01797.fc.

  PMID: 18580131 BACKGROUND

• Moyle W, Jones CJ, Murfield JE, Thalib L, Beattie ERA, Shum DKH, O'Dwyer ST, Mervin MC, Draper BM. Use of a Robotic Seal as a Therapeutic Tool to Improve Dementia Symptoms: A Cluster-Randomized Controlled Trial. J Am Med Dir Assoc. 2017 Sep 1;18(9):766-773. doi: 10.1016/j.jamda.2017.03.018. Epub 2017 Aug 2.

  PMID: 28780395 BACKGROUND

• Regier NG, Gitlin LN. Dementia-related restlessness: relationship to characteristics of persons with dementia and family caregivers. Int J Geriatr Psychiatry. 2018 Jan;33(1):185-192. doi: 10.1002/gps.4705. Epub 2017 Mar 23.

  PMID: 28332736 BACKGROUND

Related Links

• PARO Robot Web page
• Living with seal robots\_\_its sociopsychological and physiological influences on the elderly at a care house.

MeSH Terms

Conditions

Dementia; Delirium

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pamela Z Cacchione, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Geropsychiatric Nursing

Model Details: Randomized controlled trial including an intervention and attention control group

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: October 4, 2022
• Study Start: October 30, 2018
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)