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

NCT06032091 | Recruiting

• 1 other identifier: F-12829-D10484
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

end-of-life care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)

  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)

• InterRai-Palliative Care (InterRai-PC)

  Baseline and every 6.months (up to one year)

• Digital secondary outcomes

  Baseline and every 6.months (up to one year)

• Edmonton Symptom Assessment System (ESAS++)

  Baseline and every 6.months (up to one year)

Other Outcomes (5)

• Chart review

  Baseline

• Clinical Dementia Rating (CDR)

  Baseline

• General Medical Health Rating Scale (GMHR)

  Baseline

Study Arms (1)

Participants

Persons with dementia

Other: No intervention

Interventions

No intervention OTHER

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.

Participants

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults with dementia or cognitive impairment.

You may qualify if:

• People with dementia or who have a likely diagnosis of dementia
• Hospital (admitted for \>3 days)
• Nursing home resident
• \>64 years old

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Bergen Røde Kors Sykehjem AS

Bergen, Vestland, 5043, Norway

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Bettina S Husebo, MD, PhD

  University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center

  STUDY DIRECTOR

• Monica Patrascu, Eng, PhD

  University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center

  PRINCIPAL INVESTIGATOR

• Lydia Boyle, MSc, DPT

  University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center

  STUDY CHAIR

Central Study Contacts

Lydia Dawn Boyle, MSc, DPT

CONTACT

+4740518081; lydia.boyle@uib.no

Monica Patrascu, Eng, PhD

CONTACT

+4755588501; monica.patrascu@uib.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: September 11, 2023
• Study Start: May 2, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 10, 2024

Record last verified: 2023-10

Locations

NO (1)