Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437132
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-07
Brief Title:
Decoding Death and Dying in People With Dementia by Digital Thanotyping
Sponsor:
University of Bergen
Organization:
University of Bergen
Study Overview
Official Title:
Decoding Death and Dying in People With Dementia by Digital Thanotyping
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
5-D
Brief Summary:
How can healthcare professionals recognize that a person with dementia is at the end of life When people are dying their physical mental and social abilities are gradually declining No reliable method of predicting perceived dying currently exists although the technology is available sensors algorithms
The aim of Decoding Death and Dying in Dementia by Digital thanotyping 5-D is to provide methods and tools to diagnose and describe dying to an unprecedented level of accuracy and robustness within a timespan larger than is possible now focusing on the case of dying people with dementia as one of the most vulnerable and difficult to study groups 5-D combines clinical assessment tools with wearable sensing technology to monitor a pain and distressing symptoms b behavioral and psychological symptoms in dementia BPSD c oral changes and to decode the point of no return as the beginning of perceived dying
To obtain this outcome in nursing home patients with dementia the investigator will test the main hypothesis from monitoring the evolution of thanotype components over time and their interdependencies the prediction of the point of no return is possible The objectives of 5-D are
O1 Collect data using sensors and validated assessment scales O2 Develop estimation methods for BPSD from sensor measurements O3 Develop digital tools to capture the expression of pain O4 Determine the relationship between breathing and oral symptoms O5 Develop models for symptom interdependencies at the end of life and the point of no return
O6 Perform human-in-the-loop validation of developed tools models and algorithms
The ground-breaking interdisciplinary novelty of 5-D endeavors to enhance the understanding of end-of-life underlying pain and symptoms in people with dementia Advancing our theoretical knowledge to uncover how when and why perceived dying can be identified opens the doors for transferable research across several scientific fields
The aim of Decoding Death and Dying in Dementia by Digital thanotyping 5-D is to provide methods and tools to diagnose and describe dying to an unprecedented level of accuracy and robustness within a timespan larger than is possible now focusing on the case of dying people with dementia as one of the most vulnerable and difficult to study groups 5-D combines clinical assessment tools with wearable sensing technology to monitor a pain and distressing symptoms b behavioral and psychological symptoms in dementia BPSD c oral changes and to decode the point of no return as the beginning of perceived dying
To obtain this outcome in nursing home patients with dementia the investigator will test the main hypothesis from monitoring the evolution of thanotype components over time and their interdependencies the prediction of the point of no return is possible The objectives of 5-D are
O1 Collect data using sensors and validated assessment scales O2 Develop estimation methods for BPSD from sensor measurements O3 Develop digital tools to capture the expression of pain O4 Determine the relationship between breathing and oral symptoms O5 Develop models for symptom interdependencies at the end of life and the point of no return
O6 Perform human-in-the-loop validation of developed tools models and algorithms
The ground-breaking interdisciplinary novelty of 5-D endeavors to enhance the understanding of end-of-life underlying pain and symptoms in people with dementia Advancing our theoretical knowledge to uncover how when and why perceived dying can be identified opens the doors for transferable research across several scientific fields
Detailed Description:
Decoding death and dying in people with dementia by digital thanotyping 5-D aims to pioneer the methodology of defining perceived dying by a data- and knowledge-driven digital representation of the end-of-life trajectory and its associated processes inferred from different measurements The investigator proposes a novel digital thanotyping approach Greek for thánatos defined as the moment-by-moment in-situ quantification of the individual state of the human body In 5-D the investigator defines the point of no return as the declining state from which the person with dementia does not recover and marks the beginning of the perceived dying In this trial the investigator describes methods and tools to define dying to an unprecedented level of accuracy and robustness within a timespan larger than is possible now in one of the most difficult to access and vulnerable groups Results will be transferable to other life-threatening diseases relevant for hospitals and homecare services alike The investigator hypothesizes that from monitoring the evolution of clinical manifestations over time and their interdependencies the prediction of the point of no return is possible
5-D is a 5-year multicenter observation-analytic longitudinal study aimed toward method development combining clinical data and information with systems modelling and systems identification The investigator will recruit people with dementia N480 from the 10-12 Norwegian nursing homes NH from the Bergen Municipality which have a cumulative capacity of 800 patientsyear out of a total of 2500 patientsyear across the municipality The recruitment pool will be extended if necessary to other NHs within the municipality The investigator chooses NHs as the location for this research instead of patient homes because 57 of the dying population and 97 of all people with dementia in Norway die in NHs12 Most people in NHs present multimorbidity among them 52 have severe dementia Mini-Mental-State Examination MMSE score 0-11 25 moderate dementia MMSE 12-17 16 mild dementia 18-23 and 6 no dementia 24-3013 Inclusion criteria NH inhabitants 64 years with significant cognitive impairment14 Exclusion criteria people without informedpresumed consent people already participating in other studies people who might be distressed by sensors
5-D is a 5-year multicenter observation-analytic longitudinal study aimed toward method development combining clinical data and information with systems modelling and systems identification The investigator will recruit people with dementia N480 from the 10-12 Norwegian nursing homes NH from the Bergen Municipality which have a cumulative capacity of 800 patientsyear out of a total of 2500 patientsyear across the municipality The recruitment pool will be extended if necessary to other NHs within the municipality The investigator chooses NHs as the location for this research instead of patient homes because 57 of the dying population and 97 of all people with dementia in Norway die in NHs12 Most people in NHs present multimorbidity among them 52 have severe dementia Mini-Mental-State Examination MMSE score 0-11 25 moderate dementia MMSE 12-17 16 mild dementia 18-23 and 6 no dementia 24-3013 Inclusion criteria NH inhabitants 64 years with significant cognitive impairment14 Exclusion criteria people without informedpresumed consent people already participating in other studies people who might be distressed by sensors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None