PainChek® US Validation Nursing Home Study

Launched by PAINCHEK LTD · Sep 17, 2023

Keywords

ClinConnect Summary

The PainChek® US Validation Nursing Home Study is researching a new tool called PainChek®, which is a mobile app designed to help healthcare workers and caregivers assess pain in people living with moderate to severe dementia. Many individuals with dementia have difficulty communicating their pain, which can lead to it being overlooked and untreated. This study aims to see how well the PainChek® app works in identifying pain compared to another method known as the Abbey Pain Scale.

To participate in this study, individuals must have a diagnosis of moderate to severe dementia and be unable to reliably communicate their pain. They should also have lived in a nursing home for at least 30 days. Participants will be evaluated using the PainChek® app and will be supported by trained staff throughout the process. It's important to note that individuals with certain health conditions or those currently involved in other clinical trials may not be eligible. This study aims to improve pain management for people with dementia, which can enhance their quality of life.

Gender

ALL

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.