The Use of PARO to Decrease Agitation in Persons With Dementia and/or Delirium
NCT ID: NCT05565703
Last Updated: 2024-06-10
Study Results
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Basic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2018-10-30
2023-10-30
Brief Summary
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Detailed Description
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The main study outcome is agitation operationalized by the CMAI-O with restlessness operationalized by the general restlessness item on the CMAI-O defined as "fidgeting, always moving around in seat, getting up and sitting down, inability to sit still." Agitation has been associated with restless behaviors in measurement tools and consensus definitions. The International Psychogeriatric Association provided the following provisional consensus clinical and research definition of agitation in cognitive disorders "Agitation is defined broadly: 1) Occurring with patients with a cognitive impairment or dementia syndrome; 2) exhibiting behavior consistent with emotional distress; 3) manifesting in at least one of the following behaviors: excessive motor-activity (e.g. pacing, rocking, gesturing, pointing fingers, restlessness, performing repetitious mannerism); verbal aggression (e.g. yelling, speaking in an excessively loud voice, using profanity, screaming, shouting); or physical aggression (e.g. grabbing, shoving, pushing, resisting, hitting others, kicking objects or people, scratching, biting, throwing objects, hitting self, slamming doors, tearing things, and destroying property); and 4) evidencing behaviors that cause excess disability and are not solely attributable to another disorder (psychiatric, medical or substance related). In a recent concept analysis, restlessness was defined by three attributes: 1) Diffuse motor activity or motion subject to limited control judged by an observer to be excessive and/or inappropriate to the circumstances; 2) the behavior is generally non-productive or disorganized, failing to address potential underlying causes; and 3) the behavior is associated with a degree of subjective distress that is either communicated by the person with dementia or extrapolated from the behavior itself. While this is more specific than the item on the CMAI-O, the two are similar. The study protocol outlined below will be conducted on the hospital's Acute Care for the Elderly (ACE) unit. One in four admissions to the ACE unit has a diagnosis of dementia. The ACE unit has 36 beds designed to care for older adults aged ≥70 years old. ACE nurses and caregivers specialize in care of the older adult. Yet, care of the PWD with or without delirium remains challenging. Dementia or DSD-related behaviors can be difficult to console or comfort away. The ACE unit is equipped with a small activity area where PWD and persons with DSD can engage in activities. Yet, what often occurs is they are brought to this area and put in front of the television with a 1:1 caregiver sitting at their side. This rarely has a positive effect. Animal-assisted therapy (AAT) has demonstrated positive effects on agitation and restlessness in older adults. However, animals require a significant amount of care, can cause allergies, carry infections and other concerns. Due to the benefits of AAT and the recognition of its limitations, robotic animals have been introduced into clinical care. Therapeutic robotic animals have been used in the community and long-term care settings, but rarely in the acute care setting. The ACE unit is the perfect setting to pilot test the use of the therapeutic robot.
PARO (PersonAl Robot) is a relatively new therapeutic robot out of Japan currently being used in the community and long-term care settings to comfort PWD exhibiting agitation and restlessness (www.parorobots.com). PARO is used in two ways: as therapy for a predetermined purpose and a fixed time as determined by a health care provider or in unsupervised use for fun in an activity. PARO has tactile, visual, auditory, temperature, and balance sensors along with three microphones to detect sound direction and intensity. PARO recognizes its name, greetings, and a few words. PARO is equipped with a behavioral control algorithm guiding the robot's responses to the older adult's interactions. PARO has been found to reduce problematic behaviors in those with dementia in need of nursing care and lessen the burden on their families. PARO provides 1) comfort by reducing anxiety, sadness, or loneliness and relieving pain; and 2) inclusion - interaction with PARO together with caregivers and sharing fun. Eighty-five percent of persons offered the opportunity to engage with PARO had a positive therapeutic effect. PARO helps avoid the potentially dangerous side effects of antipsychotics or benzodiazepines. Most importantly, PARO has no negative side effects.
Two studies have been conducted that evaluate the use of PARO with PWD in an acute hospital setting.
Study Aims and Hypotheses
This study has 4 aims: 1) To test a standardized protocol for the introduction of PARO to PWD and persons with DSD exhibiting agitation and restlessness; 2) To evaluate the feasibility of measuring the effect of PARO on agitation and restlessness using a tablet-based assessment with the Cohen-Mansfield Agitation Inventory Observation Tool (CMAI-OT) and the Pain Assessment in Advanced Dementia (PAINAD); 3) To evaluate the feasibility of measuring the effect of PARO on the social response of PWD using The Social Interaction Tool in real-time and using videotaped interactions, and 4) To determine the effectiveness of an evidence-based cleaning protocol within and between participants.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intervention Group
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.
PARO Robotic Seal Intervention
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.
Attention Control Group
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.
Attention Control
The participants are randomly assigned and receive a one hour visit by the researcher or research assistant
Interventions
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PARO Robotic Seal Intervention
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.
Attention Control
The participants are randomly assigned and receive a one hour visit by the researcher or research assistant
Eligibility Criteria
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Inclusion Criteria
* 60 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.
Exclusion Criteria
* Has excessive secretions
* Has an open wound
* Does not assent to participate
60 Years
110 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Pamela Cacchione
Professor of Geropsychiatric Nursing
Principal Investigators
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Pamela Z Cacchione, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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PARO Robot Web page
Living with seal robots\_\_its sociopsychological and physiological influences on the elderly at a care house.
Other Identifiers
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833696
Identifier Type: -
Identifier Source: org_study_id
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