Decoding Death and Dying in People With Dementia by Digital Thanotyping

ConditionDementia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age65+

SponsorUniversity of Bergen

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

nursing home patients with dementia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

No intervention
Other intervention
The study is observational and will not include any specific interventions other than the regular care practice that the participants receive from their care providers. The study will use a wrist-mounted smartwatch for monitoring (Garmin VivoActive5). Previous studies show acceptability toward wearable devices among persons with dementia. Moreover, the investigator will use Somnofy, VitalThings, a radar installation mounted behind the patients bed. At the very end of life, the investigator will also apply Shimmer3 Ebio sensor measuring the patients breathing activities. Before starting the data collection, care staff will recognize any discomfort or distress potentially caused by the devices, in which case the relevant device will be immediately removed.

Treatment groups

480 Participants

are divided into 1 treatment group

Group A: Participants1 intervention

Trial outcomes

Primary outcomes

Edmonton Symptom Assessment System (ESAS++)

Symptom assessment for palliative care period and the end of life period, with added items: death rattle, dyspnea, sleep disturbances, emesis specific to end of life. Likert scale 0-10; 0 indicating no symptoms and 10 is worst symptom.

Time frame

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.

Digital biomarker estimations

Digital biomarker estimations for behavioural and psychological disturbances (BPSD) e.g., apathy, agitation, pain, and sleep disturbances. Moreover, different types of breathing patterns (e.g., dyspnea, death rattle, lunge edema) Estimation of activity changes and selected BPSD resulting from the combined digital phenotype modeling; these estimations are experimental and "scores" will be based on analysis of found data after data collection period.

Time frame

Baseline and every 6.months (up to three years), continuous up to 12 weeks if a serious health event occurs]

Secondary outcomes

Activities of Daily Living (ADL) - Physical Self Maintenance Scale (PSMS), Lawton and Brody, 1969.

Personal functional daily activities such as toileting, eating, self-care, movement/ambulation, transfers, bathing. 6 sections - scoring 1-5 on each, higher score indicates greater disability.

Time frame

Baseline and every 6.months (up to three years)

Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)

Validated in Norwegian nursing homes, measuring symptoms of behavioral and psychological symptoms of dementia (BPSD) such as: apathy, agitation, depression, anxiety, sleep disturbance, and appetite/eating. Gives scores 1-4 (higher numbers being daily occurance) for amount, 1-3 for intensity and burden of care related to symptom for caregiver (1-5) for each symptom.

Time frame

Baseline and every 6.months (up to three years)

Mobilization - Observation - Behavioral - Intensity - Dementia Pain Scale (MOBID-2)

Measurement of pain specific to a dementia population; visual analog scale alongside likert scale 0-10, 0 being no pain and 10 being the worst pain, validated with persons with dementia

Time frame

Baseline and every 6.months (up to three years)

InterRai-Palliative Care (InterRai-PC)

Oral health section only/specific of the InterRai-PC, assessment of symptoms

Time frame

Baseline and every 6.months (up to three years)

Other outcomes

General Medical Health Rating Scale (GMHR)

Mortality risk measure for general wellbeing, medical comorbidity, degree of somatic illness; top 2 scores are good, bottom 2 indicate serious illness with comorbidities. Bedside measure validated in NH with people with dementia.

Time frame

Baseline

Chart review

A medication list will be compiled according to the Anatomical Therapeutic Chemical classification (ATC codes); including and of life, palliative treatment

Time frame

Baseline

Clinical Dementia Rating (CDR)

Classification of cognitive impairment, 0 no cognitive impairment, 0.5 questionable impairment, 1 mild cognitive impairment, 2 moderate cognitive impairment, 3 severe cognitive impairment.

Time frame

Baseline

4 A's Test for Delirium (4AT)

Distinction between dementia and delirium for inclusion to study, \>4 indicates delirium; will be used as an exclusion criteria (participants must score \<4)

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bergen

Lead sponsor

Leiden University

Collaborator

Harvard University

Collaborator

Yale University

Collaborator

Tohoku University

Collaborator

Bergen kommune

Collaborator

Source ClinicalTrials.gov

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