Digital Phenotyping for Changes in Activity at the End of Life in People With Dementia: an Observational Trial Based on Sensing Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Activities of Daily Living (ADL) - Physical Self Maintenance Scale (PSMS), Lawton and Brody, 1969.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Activities of Daily Living (ADL) - Physical Self Maintenance Scale (PSMS), Lawton and Brody, 1969.
时间窗: Baseline and every 6.months (up to one year)
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.
Digital biomarker estimations for apathy, agitation, pain, and sleep disturbances
时间窗: Baseline and every 6.months (up to one year), continuous up to 12 weeks if a serious health event occurs
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.
次要结局
- InterRai-Palliative Care (InterRai-PC)(Baseline and every 6.months (up to one year))
- Mobilization, Observation, Behavioral, Intensity Dementia (MOBID-2)(Baseline and every 6.months (up to one year))
- Digital secondary outcomes(Baseline and every 6.months (up to one year))
- Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)(Baseline and every 6.months (up to one year))
- Edmonton Symptom Assessment System (ESAS++)(Baseline and every 6.months (up to one year))