Digital Phenotyping for Changes in Activity at the End of Life in People With Dementia

Study Overview
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Brief Summary
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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
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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 have lived in a nursing home for >1 year. 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.

Official Title
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Digital Phenotyping for Changes in Activity at the End of Life in People With Dementia: an Observational Trial Based on Sensing Technology

Conditions
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Dementia

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People with dementia (Mini-Mental-State Examination (MMSE) <20 or have a likely diagnosis of dementia based on a medical review) Hospital (admitted for >3 days) Nursing home (where they have resided for >1 year) >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 have lived <1 year in the nursing home

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>Persons with dementia | Other: No intervention<br>* 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 devices, they will be immediately removed and the participant will drop-out.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 one year) | 
| 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. | Baseline and every 6.months (up to one year) | 
| Digital biomarker estimations for apathy, agitation, pain, and sleep disturbances | Estimation of activity changes and selected behavioral disturbances 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 one year), continuous up to 12 weeks if a serious health event occurs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and every 6.months (up to one year) | 
| Mobilization, Observation, Behavioral, Intensity Dementia (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 | Baseline and every 6.months (up to one year) | 
| InterRai-Palliative Care (InterRai-PC) | Oral health section only/specific of the InterRai-PC, assessment of symptoms | Baseline and every 6.months (up to one year) | 
| Digital secondary outcomes | Device-native scores for activity and sleep. | Baseline and every 6.months (up to one year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end-of-life care