PainChek® US Validation Nursing Home Study (NCT06049732) | Clinical Trial Compass
CompletedNot Applicable
PainChek® US Validation Nursing Home Study
United States105 participantsStarted 2023-10-17
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pain score using PainChek Adult
Timeframe: Throughout the study on multiple occasions, on average every 7 days
2
Change in pain score using Abbey Pain Scale
Timeframe: Throughout the study on multiple occasions, on average every 7 days
. 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.