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

May 8, 2024 updated by: University of Bergen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
    • Vestland
      • Bergen, Vestland, Norway, 5043
        • Recruiting
        • Bergen Røde Kors Sykehjem AS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Older adults with dementia or cognitive impairment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 device, it will be immediately removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activities of Daily Living (ADL) - Physical Self Maintenance Scale (PSMS), Lawton and Brody, 1969.
Time Frame: 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.
Baseline and every 6.months (up to one year)
Digital biomarker estimations for apathy, agitation, pain, and sleep disturbances
Time Frame: 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.
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
Digital secondary outcomes
Time Frame: Baseline and every 6.months (up to one year)
Device-native scores for activity and sleep.
Baseline and every 6.months (up to one year)
Edmonton Symptom Assessment System (ESAS++)
Time Frame: 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 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)
Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)
Time Frame: 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. 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)
Time Frame: Baseline and every 6.months (up to one year)
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)
Time Frame: Baseline and every 6.months (up to one year)
Oral health section only/specific of the InterRai-PC, assessment of symptoms
Baseline and every 6.months (up to one year)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Medical Health Rating Scale (GMHR)
Time Frame: Baseline
Mortality risk measure for general wellbeing, medical comorbidity, degree of somatic illness; top 2 scores are good, bottom 2 indicate serious illness with comorbidities. Bedside measure validated in NH with people with dementia.
Baseline
4 A's Test for Delirium (4AT)
Time Frame: Baseline
Distinction between dementia and delirium for inclusion to study, >4 indicates delirium; will be used as an exclusion criteria (particpants must score <4)
Baseline
Clinical Frailty Scale (CFS)
Time Frame: Baseline
Mortality risk measure for general wellbeing, higher scores indicate greater disability (1-9)
Baseline
Chart review
Time Frame: 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.
Baseline
Clinical Dementia Rating (CDR)
Time Frame: Baseline
Classification of cognitive impairment, 0 no cognitive impairment, 0.5 questionable impairment, 1 mild cognitive impairment, 2 moderate cognitive impairment, 3 severe cognitive impairment.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Haukeland University Hospital
Helse Vest
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
  • Study Chair: Lydia Boyle, MSc, DPT, University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center
  • Principal Investigator: Monica Patrascu, Eng, PhD, University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-12829-D10484

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Based on previous experience, more data is often produced than is used in a single PhD project. This also applies to data that can be viewed and analyzed in a new context. In recent years, we have had good experience in using existing data for new PhD candidates (such as the first article in the course of the PhD studies) or for collaboration partners who send Master students/PhD candidates to our center to carry out new analyses. This may include data from traditional outcome measures or sensor data. The University of Bergen will always retain management rights and only share anonymized data for local use.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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