Status:
COMPLETED
PainChek® US Validation Nursing Home Study
Lead Sponsor:
PainChek Ltd
Collaborating Sponsors:
Donawa Lifescience Consulting SRL
TechnoSTAT Clinical Services
Conditions:
Dementia
Pain
Eligibility:
All Genders
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 abili...
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 A...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 17 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 18 2024
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06049732
Start Date
October 17 2023
End Date
September 18 2024
Last Update
November 6 2024
Active Locations (5)
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1
NewAldaya Lifescapes
Cedar Falls, Iowa, United States, 50613
2
The Meth-Wick Community
Cedar Rapids, Iowa, United States, 52405
3
Luther Manor Communities
Dubuque, Iowa, United States, 52991
4
Oaknoll Retirement Residence
Iowa City, Iowa, United States, 52246