Clinical trial NCT06049732: PainChek® US Validation Nursing Home Study
Official title: Psychometric Evaluation of the Electronic Pain Assessment Tool PainChek® Adult in Nursing Homes in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Pain
Keywords: Pain assessment
Lead sponsor: PainChek Ltd
Sponsor class: INDUSTRY
Collaborators: name: Donawa Lifescience Consulting SRL
name: TechnoSTAT Clinical Services
First posted: 2023-09-22
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

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.

Primary outcomes:
measure: Change in pain score using PainChek Adult
timeFrame: Throughout the study on multiple occasions, on average every 7 days
measure: Change in pain score using Abbey Pain Scale
timeFrame: Throughout the study on multiple occasions, on average every 7 days
Secondary outcomes:
Other outcomes:
measure: Change in heart rate using a finger pulse oximeter
timeFrame: Throughout the study on multiple occasions, on average every 7 days
measure: Change in respiratory rate using a finger pulse oximeter
timeFrame: Throughout the study on multiple occasions, on average every 7 days
Locations:
city: Cedar Falls
country: United States
facility: NewAldaya Lifescapes
state: Iowa
city: Cedar Rapids
country: United States
facility: The Meth-Wick Community
state: Iowa
city: Dubuque
country: United States
facility: Luther Manor Communities
state: Iowa
city: Iowa City
country: United States
facility: Oaknoll Retirement Residence
state: Iowa
city: New York
country: United States
facility: The New Jewish Home
state: New York
Study officials:
affiliation: Christian Retirement Services, Inc (Oaknoll)
name: Kim Bergen-Jackson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The New Jewish Home
name: Wingyun Mak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atee M, Hoti K, Parsons R, Hughes JD. Pain Assessment in Dementia: Evaluation of a Point-of-Care Technological Solution. J Alzheimers Dis. 2017;60(1):137-150. doi: 10.3233/JAD-170375.
citation: Atee M, Hoti K, Parsons R, Hughes JD. A novel pain assessment tool incorporating automated facial analysis: interrater reliability in advanced dementia. Clin Interv Aging. 2018 Jul 16;13:1245-1258. doi: 10.2147/CIA.S168024. eCollection 2018.
citation: Hoti K, Atee M, Hughes JD. Clinimetric properties of the electronic Pain Assessment Tool (ePAT) for aged-care residents with moderate to severe dementia. J Pain Res. 2018 Jun 1;11:1037-1044. doi: 10.2147/JPR.S158793. eCollection 2018.
citation: Atee M, Hoti K, Hughes JD. Psychometric Evaluation of the Electronic Pain Assessment Tool: An Innovative Instrument for Individuals with Moderate-to-Severe Dementia. Dement Geriatr Cogn Disord. 2017;44(5-6):256-267. doi: 10.1159/000485377. Epub 2018 Jan 23.
citation: Babicova I, Cross A, Forman D, Hughes J, Hoti K. Evaluation of the Psychometric Properties of PainChek(R) in UK Aged Care Residents with advanced dementia. BMC Geriatr. 2021 May 28;21(1):337. doi: 10.1186/s12877-021-02280-0.