PainChek® US Validation Nursing Home Study
Completed
Conditions studied: Dementia, Pain
In brief
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.
Key facts
- Study ID
- NCT06049732
- Run by
- PainChek Ltd
- People needed
- 105
- Starts
- 2023-10-17
- Expected to finish
- 2024-09-18
- Last updated by the study team
- 2024-11-06
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- NewAldaya Lifescapes — Cedar Falls, Iowa, United States
- The Meth-Wick Community — Cedar Rapids, Iowa, United States
- Luther Manor Communities — Dubuque, Iowa, United States
- Oaknoll Retirement Residence — Iowa City, Iowa, United States
- The New Jewish Home — New York, New York, United States
Full record on ClinicalTrials.gov
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