Clinical trial NCT06032091: Digital Phenotyping for Changes in Activity at the End of Life in People With Dementia
Official title: Digital Phenotyping for Changes in Activity at the End of Life in People With Dementia: an Observational Trial Based on Sensing Technology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia
Keywords: end-of-life care
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Helse Vest
name: Haukeland University Hospital
name: Haraldsplass Deaconess Hospital
name: Bergen Red Cross Nursing Home
First posted: 2023-09-11
Enrollment: 50
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: Older adults with dementia or cognitive impairment.

Brief summary: Background:

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.

Detailed description: About 90% of people with dementia develop behavioral and psychological symptoms such as agitation, depression and psychosis. In addition, their activity levels decrease over time. Traditional outcome measures can capture physical, mental and social activities of clinical conditions, but usually have low validity. The use of sensor technology in people with dementia is currently poorly validated. DIPH.DEM will examine whether digital tools such as a smartwatch and Somnofy (radar installation) can provide objective measurements of the patient's activities and symptoms throughout the nursing home/hospital stay, including the end of life phase. The participants are people with dementia, \>64 years, who are living in a nursing home. A selection of traditional tools and sensor data is collected at baseline and every 6 months (7 days continuous monitoring). If the participant has a significant change in health status, we will begin with continuous sensor measurements until the end of life (up to 12 weeks). DIPH.DEM can provide valuable information on activity development and symptom presentation toward the end of life in people with dementia. Informal caregivers (usually a family member) will be included to assist with the outcome measures within the study. Participants will be recruited from the Health Region West Norway and Bergen Municipality (sampling method is by invitation to volunteer). All consent procedures will be developed in accordance with Norwegian law.

Eligibility criteria: Inclusion Criteria:

* People with dementia or who have a likely diagnosis of dementia
* 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 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

Primary outcomes:
measure: Activities of Daily Living (ADL) - Physical Self Maintenance Scale (PSMS), Lawton and Brody, 1969.
timeFrame: Baseline and every 6.months (up to one year)
measure: Digital biomarker estimations for apathy, agitation, pain, and sleep disturbances
timeFrame: Baseline and every 6.months (up to one year), continuous up to 12 weeks if a serious health event occurs
Secondary outcomes:
measure: Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)
timeFrame: Baseline and every 6.months (up to one year)
measure: Mobilization, Observation, Behavioral, Intensity Dementia (MOBID-2)
timeFrame: Baseline and every 6.months (up to one year)
measure: InterRai-Palliative Care (InterRai-PC)
timeFrame: Baseline and every 6.months (up to one year)
measure: Digital secondary outcomes
timeFrame: Baseline and every 6.months (up to one year)
measure: Edmonton Symptom Assessment System (ESAS++)
timeFrame: Baseline and every 6.months (up to one year)
Other outcomes:
measure: Chart review
timeFrame: Baseline
measure: Clinical Dementia Rating (CDR)
timeFrame: Baseline
measure: General Medical Health Rating Scale (GMHR)
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:
affiliation: University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center
name: Bettina S Husebo, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center
name: Monica Patrascu, Eng, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center
name: Lydia Boyle, MSc, DPT
role: STUDY_CHAIR
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