Decoding Death and Dying in People With Dementia by Digital Thanotyping

NCT06437132 | Recruiting

• 1 other identifier: 101088414 5-D ERC-2022-CoG
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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

Conditions

Dementia

Keywords

end of life; dementia; nursing home; pain assessment and treatment; symptom assessment and treatment; mouth care

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (5)

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

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

• Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)

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

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

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

• InterRai-Palliative Care (InterRai-PC)

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

• Oral inspection

  Baseline and every 4.months (up to three years)

Other Outcomes (5)

• General Medical Health Rating Scale (GMHR)

  Baseline

• Chart review

  Baseline

• Clinical Dementia Rating (CDR)

  Baseline

Study Arms (1)

Participants

Persons with dementia

Other: No intervention

Interventions

No intervention OTHER

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.

Participants

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

nursing home patients with dementia

You may qualify if:

• Nursing home resident
• \>64 years old
• People with dementia or who have a likely diagnosis of dementia

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead
• Leiden University: collaborator
• Harvard University: collaborator
• Yale University: collaborator
• Tohoku University: collaborator
• Bergen kommune: collaborator

Study Sites (1)

Bergen Røde Kors Sykehjem AS

Bergen, Vestland, 5043, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva and plaque collection from the mouth

MeSH Terms

Conditions

Dementia; Death

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bettina S. Husebø, PhD

CONTACT

48094660; bettina.husebo@uib.no

Monica Patrascu, PhD

CONTACT

91198669; monica.patrascu@uib.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof, MD, PhD

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 31, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

NO (1)