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

Sponsor
University of Bergen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06032091
Collaborator
Helse Vest (Other), Haukeland University Hospital (Other), Haraldsplass Deaconess Hospital (Other), Bergen Red Cross Nursing Home (Other)
50
Enrollment
29
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Digital Phenotyping for Changes in Activity at the End of Life in People With Dementia: an Observational Trial Based on Sensing Technology
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Participants

Persons with dementia

Other: 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 devices, they will be immediately removed and the participant will drop-out.

Outcome Measures

Primary Outcome Measures

  1. Edmonton Symptom Assessment System (ESAS) [Baseline and every 6.months (up to one year)]

    Symptom assessment for palliative care period and the end of life period, with added items: death rattle, dyspnea, sleep disturbances, emesis.

  2. Activities of Daily Living (ADL) [Baseline and every 6.months (up to one year)]

    Personal functional daily activities such as toileting, eating, self-care, movement/ambulation, transfers, bathing.

  3. Digital biomarker estimations for apathy, agitation, pain, and sleep disturbances [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

Secondary Outcome Measures

  1. Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) [Baseline and every 6.months (up to one year)]

    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.

  2. Mobilization, Observation, Behavioral, Intensity Dementia (MOBID-2) [Baseline and every 6.months (up to one year)]

    Measurement of pain specific to a dementia population.

  3. InterRai-Palliative Care (InterRai-PC) [Baseline and every 6.months (up to one year)]

    Oral health section only/specific of the InterRai-PC

  4. Digital secondary outcomes [Baseline and every 6.months (up to one year)]

    Device-native scores for activity and sleep.

Other Outcome Measures

  1. Chart review [Baseline]

    A medication list will be compiled according to the Anatomical Therapeutic Chemical classification (ATC codes) and the Defined Daily Dose (DDD) of regularly scheduled treatments, diagnosis and medical history will be reviewed.

  2. Mini-Mental-State Examination (MMSE) [Baseline]

    Classification of disease, <20 (mild-severe dementia)

  3. Short Form of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) [Baseline]

    Classification of disease and cognitive impairment

  4. Functional Assessment Staging Tool (FAST) [Baseline]

    Staging of disease and associated with mortality risk measurement.

  5. General Medical Health Rating Scale (GMHR) [Baseline]

    Mortality risk measure for general wellbeing.

  6. 4 A's Test for Delirium (4AT) [Baseline]

    Distinction between dementia and delirium for inclusion to study.

  7. Clinical Frailty Scale (CFS) [Baseline]

    Mortality risk measure for general wellbeing.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Bergen
  • Helse Vest
  • Haukeland University Hospital
  • Haraldsplass Deaconess Hospital
  • Bergen Red Cross Nursing Home

Investigators

  • Study Director: Bettina S Husebo, MD, PhD, University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center
  • Principal Investigator: Monica Patrascu, PhD, Eng, University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center
  • Study Chair: Lydia Boyle, MSc, DPT, University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Bergen
ClinicalTrials.gov Identifier:
NCT06032091
Other Study ID Numbers:
  • F-12829-D10484
First Posted:
Sep 11, 2023
Last Update Posted:
Sep 11, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Bergen
end-of-life care
Additional relevant MeSH terms:
Dementia
Death

Study Results

No Results Posted as of Sep 11, 2023