Digital Phenotyping for Changes in Activity at the End of Life in People With Dementia
NCT ID: NCT06032091
Last Updated: 2024-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2023-05-02
2026-05-01
Brief Summary
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Almost 90% of people with dementia develop serious symptoms such as apathy, agitation, pain, and sleep disturbances. Movement and participation in daily activities also decrease dramatically over time. Traditional measures for these symptoms are usually in the form of a questionnaire and are not very accurate. Technology, such as a smartwatch, can be an effective tool for complementing traditional measures. Currently, there are few studies which look at activity and symptom measurements at the end-of-life. This makes results from this study extremely valuable for future care decisions, especially for people which may not be able to communicate their needs during the end-of-life period.
Method/Design:
DIgital PHenotyping in DEMentia (DIPH.DEM), a 3-year cross-sectional observational study (N=50), will look at activities, apathy, agitation, and sleep disturbances using sensing technologies to monitor participants at the end of life. The objective of the study is to use a smartwatch and wireless radar (bedside) device (Somnofy), in addition to validated assessment tools to describe the activity patterns for patients with dementia at the end of life (baseline and every 6.months). We hypothesize that this will enable better estimation of time of death, facilitating discussion surrounding improvement of end-of-life interventions and directives.
Discussion:
The use of sensors (smartwatch and wireless beside device) can provide valuable knowledge on living and dying with dementia, improve end-of-life directives, and provide guidance for timely, appropriate interventions, including referral to palliative services.
Impact on society:
DIPH.DEM has the potential to enable more timely, precise, and quality care for people with dementia living at home, in nursing homes, and hospitals.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants
Persons with dementia
No 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. Previous studies show acceptability toward wearable devices among persons with dementia; however, if the care staff recognize discomfort or distress caused by the device, it will be immediately removed.
Interventions
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No 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. Previous studies show acceptability toward wearable devices among persons with dementia; however, if the care staff recognize discomfort or distress caused by the device, it will be immediately removed.
Eligibility Criteria
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Inclusion Criteria
* Hospital (admitted for \>3 days)
* Nursing home resident
* \>64 years old
* Score of \<4 on the 4 A's Test for Delirium (4AT) will be required for inclusion (no delirium)
Exclusion Criteria
* People that are considered already in a health status emergency (\< 6 weeks to live)
* People that are not living in the nursing home
65 Years
ALL
No
Sponsors
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Helse Vest
OTHER
Haukeland University Hospital
OTHER
Haraldsplass Deaconess Hospital
OTHER
Bergen Red Cross Nursing Home
UNKNOWN
University of Bergen
OTHER
Responsible Party
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Principal Investigators
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Bettina S Husebo, MD, PhD
Role: STUDY_DIRECTOR
University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center
Monica Patrascu, Eng, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center
Lydia Boyle, MSc, DPT
Role: STUDY_CHAIR
University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center
Locations
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Bergen Røde Kors Sykehjem AS
Bergen, Vestland, Norway
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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F-12829-D10484
Identifier Type: -
Identifier Source: org_study_id
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