Clinical trial NCT06437132: Decoding Death and Dying in People With Dementia by Digital Thanotyping
Official title: Decoding Death and Dying in People With Dementia by Digital Thanotyping
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia
Keywords: end of life
dementia
nursing home
pain assessment and treatment
symptom assessment and treatment
mouth care
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Leiden University
name: Harvard University
name: Yale University
name: Tohoku University
name: Bergen kommune
First posted: 2024-05-31
Enrollment: 480
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: nursing home patients with dementia

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

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 (N=480) from the 10-12 Norwegian nursing homes (NH) from the Bergen Municipality, which have a cumulative capacity of \>800 patients/year (out of a total of 2500 patients/year 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 NHs.(12) 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 (24-30).(13) Inclusion criteria: NH inhabitants \>64 years, with significant cognitive impairment.(14) Exclusion criteria: people without informed/presumed consent, people already participating in other studies, people who might be distressed by sensors.

Eligibility criteria: Inclusion Criteria:

* Nursing home resident
* \>64 years old
* People with dementia or who have a likely diagnosis of dementia
* Score of \<4 on the 4 A's Test for Delirium (4AT) will be required for inclusion (no delirium)

Exclusion Criteria:

* People without dementia or cognitive impairment
* People that are considered already in a health status emergency (\< 6 weeks to live)
* People that are not living in the nursing home
* People without informed/presumed consent

Primary outcomes:
measure: Edmonton Symptom Assessment System (ESAS++)
timeFrame: Baseline and every 6.months (up to three years); When the patient is suggested to be at the end of life and is dying; ESAS will be assessed once the day.
measure: Digital biomarker estimations
timeFrame: Baseline and every 6.months (up to three years), continuous up to 12 weeks if a serious health event occurs]
Secondary outcomes:
measure: Activities of Daily Living (ADL) - Physical Self Maintenance Scale (PSMS), Lawton and Brody, 1969.
timeFrame: Baseline and every 6.months (up to three years)
measure: Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)
timeFrame: Baseline and every 6.months (up to three years)
measure: Mobilization - Observation - Behavioral - Intensity - Dementia Pain Scale (MOBID-2)
timeFrame: Baseline and every 6.months (up to three years)
measure: InterRai-Palliative Care (InterRai-PC)
timeFrame: Baseline and every 6.months (up to three years)
measure: Oral inspection
timeFrame: Baseline and every 4.months (up to three years)
Other outcomes:
measure: General Medical Health Rating Scale (GMHR)
timeFrame: Baseline
measure: Chart review
timeFrame: Baseline
measure: Clinical Dementia Rating (CDR)
timeFrame: Baseline
measure: 4 A's Test for Delirium (4AT)
timeFrame: Baseline
measure: Clinical Frailty Scale (CFS)
timeFrame: Baseline
Locations:
city: Bergen
country: Norway
facility: Bergen Røde Kors Sykehjem AS
state: Vestland
Study officials:
References: