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Decoding Death and Dying in People With Dementia by Digital Thanotyping

Study acronym: 5-D
StatusEnrolling by Invitation
PhaseNot specified
Started
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Trial flagged as At Risk
Enrollment reduced 44% 480 → 270 participants
See other at-risk trials from University of Bergen

Record History

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  1. Notable Enrollment reduced: 480 → 270 participants Show 5 more changesShow less
    • Trial status changed: Recruiting → Enrolling by Invitation
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Study description revised
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,978 trials monitored
See 106 trials at risk
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
Trial Details
NCT Number NCT06437132
Lead Sponsor University of Bergen
Collaborators: Leiden University, Harvard University, Yale University, Tohoku University, Bergen kommune
Conditions
(from sponsor)
Dementia
Related terms Death, Dementia, Psychomotor Agitation, Respiratory Aspiration
Enrollment 270 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov