Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-27 @ 4:02 AM
Study NCT ID:
NCT06049732
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2023-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PainChek® US Validation Nursing Home Study
Sponsor:
PainChek Ltd
Organization:
Study Overview
Official Title:
Psychometric Evaluation of the Electronic Pain Assessment Tool PainChek® Adult in Nursing Homes in the United States
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: