DementiaPARONCT05565703
The Use of PARO to Decrease Agitation in Persons With Dementia and/or Delirium
A study testing PARO Robotic Seal Intervention in people with Dementia and Delirium, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 110 years
- What is being tested?
- PARO Robotic Seal Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2018to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- On isolation
- Has excessive secretions
- Has an open wound
- Does not assent to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Use of PARO to Decrease Agitation and Restlessness in Persons With Dementia and or Delirium
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.
Read the 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.
- Being tested
- PARO Robotic Seal Intervention, Attention Control
- Keywords
- Robotics, Nursing, nonpharmacological interventions
- Medical subject headings
- Dementia, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARO Robotic Seal InterventionOther
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 ControlOther
The participants are randomly assigned and receive a one hour visit by the researcher or research assistant
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Obtained for a hospital report
Measured: 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
found in the electronic health record
Measured: The medications are recorded within 2 hours of the Participant's Day 1 and Day 2
Length of stay
number of days in the hospital found in the electronic record after discharge
Measured: Within 6 weeks of the participant's discharge the number of days are retrieved from the participant electronic records
Emotional response to the robot
qualitative descriptions of the individual's response and interaction with the robot
Measured: Within one year of the participants engagement with the study the videotapes are reviewed and coded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start30 Oct 2018
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial including an intervention and attention control group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Cacchione, University of Pennsylvania
- Investigators
- Pamela Z Cacchione, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565703
- Sponsor's protocol ID
- 833696
- Acronym
- PARO
- Status last verified
- Jun 2024
- First submitted
- 4 Aug 2022
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9154580Cohen-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.
PubMed 2715584Cummings 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.
PubMed 25311499Dodds 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.
PubMed 29569863Fick 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.
PubMed 18156861Griffiths 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.
PubMed 30968783Herr 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.
PubMed 20128526Horgas 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.
PubMed 18580131Moyle 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.
PubMed 28780395Regier 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.
PubMed 28332736
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of PARO to Decrease Agitation and Restlessness in Persons With Dementia and or Delirium
- ClinicalTrials.gov ID
- NCT05565703
- Acronym / sponsor ID
- PARO / 833696
- Keywords
- Robotics, Nursing, nonpharmacological interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial including an intervention and attention control group
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: PARO Robotic Seal InterventionThis 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. |
| Attention Control Group | Active comparator | Other: Attention ControlThis 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. |
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- On isolation
- Has excessive secretions
- Has an open wound
- Does not assent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PARO Robotic Seal InterventionPARO 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. | Other | Intervention Group |
| Attention ControlThe participants are randomly assigned and receive a one hour visit by the researcher or research assistant | Other | Attention Control Group |
Primary outcome
Cohen-Mansfield agitation inventory observational
Time frame: Day 1 this tool is assessed at baseline
a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.
Cohen-Mansfield agitation inventory observational
Time frame: Day 2 this tool is assessed at baseline
a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.
Cohen-Mansfield agitation inventory observational
Time frame: Day 1 this tool is assessed again 20 minutes post baseline assessment
a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.
Cohen-Mansfield agitation inventory observational
Time frame: Day 2 this tool is assessed again 20 minutes post baseline assessment
a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.
Cohen-Mansfield agitation inventory observational
Time frame: Day 1 this tool is assessed 40 minutes post baseline assessment
a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.
Cohen-Mansfield agitation inventory observational
Time frame: Day 2 this tool is assessed 40 minutes post baseline assessment
a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.
Cohen-Mansfield agitation inventory observational
Time frame: Day 1 this tool is assessed at 60 minutes post baseline
a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.
Cohen-Mansfield agitation inventory observational
Time frame: Day 2 this tool is assessed at 60 minutes post baseline
a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.
Cohen-Mansfield agitation inventory observational
Time frame: Day 1 this tool is assessed at 70 minutes after the baseline
a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.
Cohen-Mansfield agitation inventory observational
Time frame: Day 2 this tool is assessed at 70 minutes after the baseline
a 29 item observational scale for dementia and delirium related agitation behaviors- score range is 29 to 116 with higher scores indicating more agitation.
Pain in Dementia Scale
Time frame: Day 1 this tool is assessed at baseline
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.
Pain in Dementia Scale
Time frame: Day 2 this tool is assessed at baseline
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.
Pain in Dementia Scale
Time frame: Day 1 and 2 this tool is assessed again 20 minutes post baseline assessment
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.
Pain in Dementia Scale
Time frame: Day 1 this tool is assessed again 20 minutes post baseline assessment
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.
Pain in Dementia Scale
Time frame: Day 2 this tool is assessed 40 minutes post baseline assessment
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.
Pain in Dementia Scale
Time frame: Day 1 this tool is assessed at 60 minutes post baseline
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.
Pain in Dementia Scale
Time frame: Day 2 this tool is assessed at 60 minutes post baseline
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.
Pain in Dementia Scale
Time frame: Day 1 this tool is assessed at 70 minutes post the baseline
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.
Pain in Dementia Scale
Time frame: Day 2 this tool is assessed at 70 minutes post the baseline
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.
Social Interaction Tool
Time frame: Day 1 this tool is completed at the end of the 60 minute interaction with the PARO robot
This observational tool captures the interactions between the participant and the robot during the 60 minute intervention
Social Interaction Tool
Time frame: Day 2 this tool is completed at the end of the 60 minute interaction with the PARO robot
This observational tool captures the interactions between the participant and the robot during the 60 minute intervention
4 secondary outcomes
Number of 1:1 sitter hours
Time frame: 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
Time frame: The medications are recorded within 2 hours of the Participant's Day 1 and Day 2
Length of stay
Time frame: Within 6 weeks of the participant's discharge the number of days are retrieved from the participant electronic records
Emotional response to the robot
Time frame: Within one year of the participants engagement with the study the videotapes are reviewed and coded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Background: PubMed 9154580Cohen-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.
- Background: PubMed 2715584Cohen-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.
- Background: PubMed 25311499Cummings 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.
- Background: PubMed 29569863Dodds 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.
- Background: PubMed 18156861Fick 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.
- Background: PubMed 30968783Griffiths 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.
- Background: PubMed 20128526Herr 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.
- Background: PubMed 18580131Horgas 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.
- Background: PubMed 28780395Moyle 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.
- Background: PubMed 28332736Regier 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.
- PARO Robot Web pageLink provided by the sponsor.
- Living with seal robots\_\_its sociopsychological and physiological influences on the elderly at a care house.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Z Cacchione, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PARO Robotic Seal Intervention in people with Dementia and Delirium, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohen-Mansfield agitation inventory observational (time frame: Day 1 this tool is assessed at baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05565703, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.