Clinical trial NCT05565703: The Use of PARO to Decrease Agitation in Persons With Dementia and/or Delirium
Official title: The Use of PARO to Decrease Agitation and Restlessness in Persons With Dementia and or Delirium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Delirium
Keywords: Robotics
Nursing
nonpharmacological interventions
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 104
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial including an intervention and attention control group
Primary purpose: OTHER

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.

Detailed description: Hospitalized persons with dementia (PWD) and or delirium superimposed on dementia (DSD) are particularly vulnerable to stress due to their decreased ability to interpret their environment and the invasive procedures required. The stress of the hospital environment can exacerbate dementia-related behaviors such as agitation and restlessness and precipitate DSD. Both can cause increased use of psychotropic medications, use of paid caregivers to provide one on one observation, costs of care, and length of stay. DSD is associated with hypoactive symptoms or hyperactive symptoms such as agitation and restlessness.

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.

Eligibility criteria: Inclusion Criteria:

* A patient on the acute Care for Elders unit
* 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:

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

Primary outcomes:
measure: Cohen-Mansfield agitation inventory observational
timeFrame: Day 1 this tool is assessed at baseline
measure: Cohen-Mansfield agitation inventory observational
timeFrame: Day 2 this tool is assessed at baseline
measure: Cohen-Mansfield agitation inventory observational
timeFrame: Day 1 this tool is assessed again 20 minutes post baseline assessment
measure: Cohen-Mansfield agitation inventory observational
timeFrame: Day 2 this tool is assessed again 20 minutes post baseline assessment
measure: Cohen-Mansfield agitation inventory observational
timeFrame: Day 1 this tool is assessed 40 minutes post baseline assessment
measure: Cohen-Mansfield agitation inventory observational
timeFrame: Day 2 this tool is assessed 40 minutes post baseline assessment
measure: Cohen-Mansfield agitation inventory observational
timeFrame: Day 1 this tool is assessed at 60 minutes post baseline
measure: Cohen-Mansfield agitation inventory observational
timeFrame: Day 2 this tool is assessed at 60 minutes post baseline
measure: Cohen-Mansfield agitation inventory observational
timeFrame: Day 1 this tool is assessed at 70 minutes after the baseline
measure: Cohen-Mansfield agitation inventory observational
timeFrame: Day 2 this tool is assessed at 70 minutes after the baseline
measure: Pain in Dementia Scale
timeFrame: Day 1 this tool is assessed at baseline
measure: Pain in Dementia Scale
timeFrame: Day 2 this tool is assessed at baseline
measure: Pain in Dementia Scale
timeFrame: Day 1 and 2 this tool is assessed again 20 minutes post baseline assessment
measure: Pain in Dementia Scale
timeFrame: Day 1 this tool is assessed again 20 minutes post baseline assessment
measure: Pain in Dementia Scale
timeFrame: Day 2 this tool is assessed 40 minutes post baseline assessment
measure: Pain in Dementia Scale
timeFrame: Day 1 this tool is assessed at 60 minutes post baseline
measure: Pain in Dementia Scale
timeFrame: Day 2 this tool is assessed at 60 minutes post baseline
measure: Pain in Dementia Scale
timeFrame: Day 1 this tool is assessed at 70 minutes post the baseline
measure: Pain in Dementia Scale
timeFrame: Day 2 this tool is assessed at 70 minutes post the baseline
measure: Social Interaction Tool
timeFrame: Day 1 this tool is completed at the end of the 60 minute interaction with the PARO robot
measure: Social Interaction Tool
timeFrame: Day 2 this tool is completed at the end of the 60 minute interaction with the PARO robot
Secondary outcomes:
measure: Number of 1:1 sitter hours
timeFrame: 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
measure: Number of psychoactive medications
timeFrame: The medications are recorded within 2 hours of the Participant's Day 1 and Day 2
measure: Length of stay
timeFrame: Within 6 weeks of the participant's discharge the number of days are retrieved from the participant electronic records
measure: Emotional response to the robot
timeFrame: Within one year of the participants engagement with the study the videotapes are reviewed and coded.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Pamela Z Cacchione, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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