DementiaNCT06049732
PainChek® US Validation Nursing Home Study
An observational study of Dementia and Pain, run by PainChek Ltd at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- PainChek®
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Oct 2023to 18 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
NewAldaya Lifescapes
Cedar Falls, Iowa, 50613
The Meth-Wick Community
Cedar Rapids, Iowa, 52405
Luther Manor Communities
Dubuque, Iowa, 52991
Oaknoll Retirement Residence
Iowa City, Iowa, 52246
The New Jewish Home
New York, New York, 10025
About this study
Official title: Psychometric Evaluation of the Electronic Pain Assessment Tool PainChek® Adult in Nursing Homes in the United States
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.
Read the 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 Abbey Pain Scale (APS).
In addition, the study data will be used to demonstrate test-retest reliability of the PainChek® device.
Study Objectives: PainChek® has been calibrated and successfully validated against the Abbey Pain Scale in Australia and the United Kingdom. The primary objective of the study is to demonstrate the validity of this calibration in the US intended use population.
As secondary objective, this study will the test-retest reliability of PainChek® as compared to the Abbey Pain Scale (APS).
As an additional exploratory objective, the association between respiratory rate (RR) and heart rate (HR) and pain scores detected by PainChek® and APS will be investigated.
Data generated in this study will be used in support of a United States Food and Drug Administration (FDA) De Novo submission.
Clinical Sites: The study will include between 5 and 12 nursing homes in the US.
Study Procedures: The study is entirely observational and follows the patient's standard of care (SOC).
Each participating site will assign raters providing pain assessments for the study. Each rater will be requested to assess pain of enrolled subjects using either the PainChek® device (PainChek® raters) or the Abbey Pain Scale (APS raters). Raters from all participating sites will be trained on the assessment tools by PainChek.
Consent to participate in the study will be requested from legally authorized representatives (LARs) of subjects with moderate-to-severe dementia potentially eligible to participate in the study. Following consent signature by the subject's LAR, subjects will be enrolled in the study. Weekly pain ratings of enrolled subjects will be done concurrently by two independent raters using PainChek® and the Abbey Pain Scale (APS). Pain assessments will be done twice (at rest and post movement) at each session. At the end of both the at rest and post movement pain assessments, the subject's respiratory rate (RR) and heart rate (HR) will be measured using a fingertip pulse oximeter. In addition, the study coordinator will document changes in clinical status of the resident between each encounter.
Raters will be blinded to each other's assessment, to prior pain assessments on the same subject and to subject's clinical status as assessed by the study coordinator. Each subject is planned to be assessed up to 10 times for maximum study duration per subject of 16 weeks.
- Being tested
- PainChek®
- Keywords
- Pain assessment
- Medical subject headings
- Dementia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PainChek®Device
Also called Abbey Pain Scale
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: PainChek® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Throughout the study on multiple occasions, on average every 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start17 Oct 2023
- Primary completion18 Jun 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- PainChek Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l., TechnoSTAT Clinical Services
- Responsible party
- Sponsor
- Investigators
- Kim Bergen-Jackson, PhD, Principal investigator, Christian Retirement Services, Inc (Oaknoll)Wingyun Mak, PhD, Principal investigator, The New Jewish Home
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049732
- Sponsor's protocol ID
- PCK - US001/2020
- Status last verified
- Nov 2024
- First submitted
- 10 Sep 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Publications
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.
PubMed 28800333Atee 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.
PubMed 30038491Hoti 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.
PubMed 29910632Atee 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.
PubMed 29393207Babicova 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.
PubMed 34049501
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Evaluation of the Electronic Pain Assessment Tool PainChek® Adult in Nursing Homes in the United States
- ClinicalTrials.gov ID
- NCT06049732
- Acronym / sponsor ID
- PCK - US001/2020
- Keywords
- Pain assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- PainChek LtdIndustry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l., TechnoSTAT Clinical Services
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Abbey Pain Scale (APS).
In addition, the study data will be used to demonstrate test-retest reliability of the PainChek® device.
Study Objectives: PainChek® has been calibrated and successfully validated against the Abbey Pain Scale in Australia and the United Kingdom. The primary objective of the study is to demonstrate the validity of this calibration in the US intended use population.
As secondary objective, this study will the test-retest reliability of PainChek® as compared to the Abbey Pain Scale (APS).
As an additional exploratory objective, the association between respiratory rate (RR) and heart rate (HR) and pain scores detected by PainChek® and APS will be investigated.
Data generated in this study will be used in support of a United States Food and Drug Administration (FDA) De Novo submission.
Clinical Sites: The study will include between 5 and 12 nursing homes in the US.
Study Procedures: The study is entirely observational and follows the patient's standard of care (SOC).
Each participating site will assign raters providing pain assessments for the study. Each rater will be requested to assess pain of enrolled subjects using either the PainChek® device (PainChek® raters) or the Abbey Pain Scale (APS raters). Raters from all participating sites will be trained on the assessment tools by PainChek.
Consent to participate in the study will be requested from legally authorized representatives (LARs) of subjects with moderate-to-severe dementia potentially eligible to participate in the study. Following consent signature by the subject's LAR, subjects will be enrolled in the study. Weekly pain ratings of enrolled subjects will be done concurrently by two independent raters using PainChek® and the Abbey Pain Scale (APS). Pain assessments will be done twice (at rest and post movement) at each session. At the end of both the at rest and post movement pain assessments, the subject's respiratory rate (RR) and heart rate (HR) will be measured using a fingertip pulse oximeter. In addition, the study coordinator will document changes in clinical status of the resident between each encounter.
Raters will be blinded to each other's assessment, to prior pain assessments on the same subject and to subject's clinical status as assessed by the study coordinator. Each subject is planned to be assessed up to 10 times for maximum study duration per subject of 16 weeks.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nursing home residents with moderate to severe dementia | – | Device: PainChek®Simultaneous pain assessments using PainChek® and the Abbey Pain Scale undertaken by two independent pain assessors, blinded to each others results |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Subjects enrolled in the study should meet all of the following criteria:
Key exclusion criteria (4 listed)
- Subjects enrolled in the study should not meet any of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PainChek®Also: Abbey Pain ScaleBoth 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 | Device | Nursing home residents with moderate to severe dementia |
Primary outcome
Change in pain score using PainChek Adult
Time frame: Throughout the study on multiple occasions, on average every 7 days
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.
Change in pain score using Abbey Pain Scale
Time frame: Throughout the study on multiple occasions, on average every 7 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Background: PubMed 28800333Atee 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.
- Background: PubMed 30038491Atee 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.
- Background: PubMed 29910632Hoti 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.
- Background: PubMed 29393207Atee 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.
- Background: PubMed 34049501Babicova 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Bergen-Jackson, PhD principal investigator
Christian Retirement Services, Inc (Oaknoll)
Wingyun Mak, PhD principal investigator
The New Jewish Home
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Pain, run by PainChek Ltd at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score using PainChek Adult (time frame: Throughout the study on multiple occasions, on average every 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06049732, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024; AzTrials last refreshed its copy on 27 Oct 2026.