PainChek® US Validation Nursing Home Study

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.

Inclusion criteria

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

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

• Mini-Mental State Examination (MMSE) score < 19 OR
• MDS Cognitive Performance Scale (CPS) score > 3 OR
• Another cognitive assessment tool routinely used within the aged care facility allowing the identification of subjects with moderate-to-severe dementia
• are unable to reliably self-report pain as determined by the caregiver
• have been living in the aged care home for at least 30 days prior to the day of screening
• 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:

• 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)
• the treating physician determines it is inappropriate to assess the subject for pain
• 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.