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PainChek® US Validation Nursing Home Study

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ClinicalTrials.gov Identifier: NCT06049732
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : April 5, 2024
Sponsor:
Collaborators:
Donawa Lifescience Consulting SRL
TechnoSTAT Clinical Services
Information provided by (Responsible Party):
PainChek Ltd

Study Description
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Brief Summary:

Pain is common amongst people living with dementia. However, as people's dementia worsens their ability to self-report pain diminishes because of limitations in their cognition and communication abilities. As a result pain in people with moderate to severe dementia often goes under-recognised and undertreated.

PainChek® is a technology-enabled, observational pain assessment tool, in the form of a mobile application designed specifically to assist healthcare professionals and professional caregivers assess pain in people with moderate severe dementia. In this study the investigators aim to assess the performance of PainChek® in assessing pain in nursing home residents with moderate to severe dementia compared to the Abbey Pain Scale.


Condition or disease Intervention/treatment
Dementia Pain Device: PainChek®

Detailed Description:

Study Design: This is a prospective, multicenter, observational study with the primary objective to validate PainChek® for assessing pain in subjects with moderate-to-severe dementia compared to the Abbey Pain Scale (APS).

In addition, the study data will be used to demonstrate test-retest reliability of the PainChek® device.

Study Objectives: PainChek® has been calibrated and successfully validated against the Abbey Pain Scale in Australia and the United Kingdom. The primary objective of the study is to demonstrate the validity of this calibration in the US intended use population.

As secondary objective, this study will the test-retest reliability of PainChek® as compared to the Abbey Pain Scale (APS).

As an additional exploratory objective, the association between respiratory rate (RR) and heart rate (HR) and pain scores detected by PainChek® and APS will be investigated.

Data generated in this study will be used in support of a United States Food and Drug Administration (FDA) De Novo submission.

Clinical Sites: The study will include between 5 and 12 nursing homes in the US.

Study Procedures: The study is entirely observational and follows the patient's standard of care (SOC).

Each participating site will assign raters providing pain assessments for the study. Each rater will be requested to assess pain of enrolled subjects using either the PainChek® device (PainChek® raters) or the Abbey Pain Scale (APS raters). Raters from all participating sites will be trained on the assessment tools by PainChek.

Consent to participate in the study will be requested from legally authorized representatives (LARs) of subjects with moderate-to-severe dementia potentially eligible to participate in the study. Following consent signature by the subject's LAR, subjects will be enrolled in the study. Weekly pain ratings of enrolled subjects will be done concurrently by two independent raters using PainChek® and the Abbey Pain Scale (APS). Pain assessments will be done twice (at rest and post movement) at each session. At the end of both the at rest and post movement pain assessments, the subject's respiratory rate (RR) and heart rate (HR) will be measured using a fingertip pulse oximeter. In addition, the study coordinator will document changes in clinical status of the resident between each encounter.

Raters will be blinded to each other's assessment, to prior pain assessments on the same subject and to subject's clinical status as assessed by the study coordinator. Each subject is planned to be assessed up to 10 times for maximum study duration per subject of 16 weeks.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Psychometric Evaluation of the Electronic Pain Assessment Tool PainChek® Adult in Nursing Homes in the United States
Actual Study Start Date : October 17, 2023
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Nursing home residents with moderate to severe dementia
Simultaneous pain assessments using PainChek® and the Abbey Pain Scale undertaken by two independent pain assessors, blinded to each others results
 Device: PainChek®
Both PainChek® and the Abbey Pain Scale are observational pain assessment tools which have been designed to assist healthcare professionals and profession caregivers assess pain in people who cannot self-report their pain
Other Name: Abbey Pain Scale


Outcome Measures
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Primary Outcome Measures :
  1. Change in pain score using PainChek Adult [ Time Frame: Throughout the study on multiple occasions, on average every 7 days ]
    Change in pain measurement using PainChek Adult pain scale with the resident At Rest then Post Movement or vice versa. The scale includes 42 items across 6 domains, with scores of 0-6 representing No Pain, 7-11 Mild Pain, 12-15 Moderate Pain and 16-42 Severe Pain.

  2. Change in pain score using Abbey Pain Scale [ Time Frame: Throughout the study on multiple occasions, on average every 7 days ]
    Change in pain measurement using the Abbey Pain Scale with the resident At Rest then Post Movement or vice versa. The scale includes 18 items across 6 domains, with scores of 0-2 representing No Pain, 3-7 Mild Pain, 8-13 Moderate Pain and 14-18 Severe Pain.


Other Outcome Measures:
  1. Change in heart rate using a finger pulse oximeter [ Time Frame: Throughout the study on multiple occasions, on average every 7 days ]
    Change in heart rate measured using a Masimo MightySat™ Rx Finger Pulse Oximeter with the subject At Rest then Post Movement or vice versa

  2. Change in respiratory rate using a finger pulse oximeter [ Time Frame: Throughout the study on multiple occasions, on average every 7 days ]
    Change in respiratory rate measured using a Masimo MightySat™ Rx Finger Pulse Oximeter with the subject At Rest then Post Movement or vice versa


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will include non-verbal subjects diagnosed with moderate to severe dementia living in nursing homes in the US. All comers will be evaluated for study eligibility.
Criteria

Inclusion Criteria:

  • Subjects enrolled in the study should meet all of the following criteria:

    1. have been diagnosed with moderate-to-severe dementia on the basis of the score obtained with one of the following tools:

      1. Mini-Mental State Examination (MMSE) score < 19 OR
      2. MDS Cognitive Performance Scale (CPS) score > 3 OR
      3. Another cognitive assessment tool routinely used within the aged care facility allowing the identification of subjects with moderate-to-severe dementia
    2. are unable to reliably self-report pain as determined by the caregiver
    3. have been living in the aged care home for at least 30 days prior to the day of screening
    4. must have had an informed consent signed by the subject's legally authorized representative

Exclusion Criteria:

  • Subjects enrolled in the study should not meet any of the following criteria:

    1. subject is unable to partially or completely exhibit any facial expression (e.g. as a result of a facial palsy, facial injuries or other pathologies)
    2. the treating physician determines it is inappropriate to assess the subject for pain
    3. subject is currently receiving or has received in the last 30 days prior to screening an investigational product and/or participated in another clinical trial.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06049732


Contacts
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Contact: Jeffery D Hughes, PhD +61412416888 jeff.hughes@painchek.com
Contact: Kreshnik Hoti, PhD Kreshnik.Hoti@painchek.com

Locations
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United States, Iowa
NewAldaya Lifescapes Recruiting
Cedar Falls, Iowa, United States, 50613
Contact: Kim Bergen-Jackson, PhD    319-466-3014    kbergen-jackson@oaknoll.com   
The Meth-Wick Community Recruiting
Cedar Rapids, Iowa, United States, 52405
Contact: Kim Bergen-Jackson, PhD    319-446-3014    kbergen-jackson@oaknoll.com   
Luther Manor Communities Recruiting
Dubuque, Iowa, United States, 52991
Contact: Kim Bergen-Jackson, PhD    319-466-3014    kbergen-jackson@oaknoll.com   
Oaknoll Retirement Residence Recruiting
Iowa City, Iowa, United States, 52246
Contact: Kim Bergen-Jackson, PhD    319-466-3014    kbergen-jackson@oaknoll.com   
United States, New York
The New Jewish Home Recruiting
New York, New York, United States, 10025
Contact: Wingyun Mak, PhD    212-870-7520    WMak@jewishhome.org   
Contact: Orah Burack, PhD    917-608-1345    OBurack@jewishhome.ord   
Sponsors and Collaborators
PainChek Ltd
Donawa Lifescience Consulting SRL
TechnoSTAT Clinical Services
Investigators
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Principal Investigator: Kim Bergen-Jackson, PhD Christian Retirement Services, Inc (Oaknoll)
Principal Investigator: Wingyun Mak, PhD The New Jewish Home
More Information
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Publications:

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Responsible Party: PainChek Ltd
ClinicalTrials.gov Identifier: NCT06049732    
Other Study ID Numbers: PCK - US001/2020
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PainChek Ltd:
Pain assessment
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders