PainChek® US Validation Nursing Home Study

NCT06049732 | Completed DMC

• 1 other identifier: PCK - US001/2020
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 5

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.

Conditions

Dementia; Pain

Keywords

Pain assessment

Outcome Measures

Primary Outcomes (2)

• Change in pain score using PainChek Adult

  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.

  Throughout the study on multiple occasions, on average every 7 days

• Change in pain score using Abbey Pain Scale

  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.

  Throughout the study on multiple occasions, on average every 7 days

Other Outcomes (2)

• Change in heart rate using a finger pulse oximeter

  Throughout the study on multiple occasions, on average every 7 days

• Change in respiratory rate using a finger pulse oximeter

  Throughout the study on multiple occasions, on average every 7 days

Study Arms (1)

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®

Interventions

PainChek® DEVICE

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

Also known as: Abbey Pain Scale

Nursing home residents with moderate to severe dementia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PainChek Ltd: lead
• Donawa Lifescience Consulting SRL: collaborator
• TechnoSTAT Clinical Services: collaborator

Study Sites (5)

NewAldaya Lifescapes

Cedar Falls, Iowa, 50613, United States

Location

The Meth-Wick Community

Cedar Rapids, Iowa, 52405, United States

Location

Luther Manor Communities

Dubuque, Iowa, 52991, United States

Location

Oaknoll Retirement Residence

Iowa City, Iowa, 52246, United States

Location

The New Jewish Home

New York, New York, 10025, United States

Location

Related Publications (5)

• 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.

  PMID: 28800333 BACKGROUND

• 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.

  PMID: 30038491 BACKGROUND

• 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.

  PMID: 29910632 BACKGROUND

• 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.

  PMID: 29393207 BACKGROUND

• 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.

  PMID: 34049501 BACKGROUND

MeSH Terms

Conditions

Dementia; Pain

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kim Bergen-Jackson, PhD

  Christian Retirement Services, Inc (Oaknoll)

  PRINCIPAL INVESTIGATOR

• Wingyun Mak, PhD

  The New Jewish Home

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 22, 2023
• Study Start: October 17, 2023
• Primary Completion: June 18, 2024
• Study Completion: September 18, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)