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DementiaDIPHDEMNCT06032091

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

An observational study of Dementia, run by University of Bergen at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Dementia
How many people
50 participants
Where
1 siteNorway
Study dates
2 May 2023to 1 May 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Older adults with dementia or cognitive impairment.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Lydia Dawn Boyle, MSc, DPT contact

+4740518081

lydia.boyle@uib.no

Monica Patrascu, Eng, PhD contact

+4755588501

monica.patrascu@uib.no

Norway1 site, 1 recruiting

  • Bergen Røde Kors Sykehjem AS

    Bergen, Vestland, 5043

    Morten Amundsen, +4755397700, postmottak@brks.no

    Recruiting

Other trials in Norway

About this study

Official title: 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.

Read more

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.

Read the 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.

Conditions
Dementia
Being tested
No intervention
Keywords
end-of-life care
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    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.

Study groups in NCT06032091
Study groupRoleWhat they receive
ParticipantsPersons with dementia
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: Baseline and every 6.months (up to one year), continuous up to 12 weeks if a serious health event occurs

Secondary outcomes (5)

  1. 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.

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

  2. 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

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

  3. InterRai-Palliative Care (InterRai-PC)

    Oral health section only/specific of the InterRai-PC, assessment of symptoms

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

  4. Digital secondary outcomes

    Device-native scores for activity and sleep.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2023
  2. Study start2 May 2023
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06032091
Sponsor's protocol ID
F-12829-D10484
Acronym
DIPHDEM
Status last verified
Oct 2023
First submitted
9 Jun 2023
Last updated
10 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Publications

  • Sallnow L, Smith R, Ahmedzai SH, Bhadelia A, Chamberlain C, Cong Y, Doble B, Dullie L, Durie R, Finkelstein EA, Guglani S, Hodson M, Husebo BS, Kellehear A, Kitzinger C, Knaul FM, Murray SA, Neuberger J, O'Mahony S, Rajagopal MR, Russell S, Sase E, Sleeman KE, Solomon S, Taylor R, Tutu van Furth M, Wyatt K; Lancet Commission on the Value of Death. Report of the Lancet Commission on the Value of Death: bringing death back into life. Lancet. 2022 Feb 26;399(10327):837-884. doi: 10.1016/S0140-6736(21)02314-X. Epub 2022 Feb 1. No abstract available.

    PubMed 35114146

  • Sandvik RK, Selbaek G, Bergh S, Aarsland D, Husebo BS. Signs of Imminent Dying and Change in Symptom Intensity During Pharmacological Treatment in Dying Nursing Home Patients: A Prospective Trajectory Study. J Am Med Dir Assoc. 2016 Sep 1;17(9):821-7. doi: 10.1016/j.jamda.2016.05.006. Epub 2016 Jun 16.

    PubMed 27321869

  • Abbott KM, Bangerter LR, Humes S, Klumpp R, Van Haitsma K. "It's important, but...": Perceived Barriers and Situational Dependencies to Social Contact Preferences of Nursing Home Residents. Gerontologist. 2018 Nov 3;58(6):1126-1135. doi: 10.1093/geront/gnx109.

    PubMed 28645167

  • Vik-Mo AO, Giil LM, Borda MG, Ballard C, Aarsland D. The individual course of neuropsychiatric symptoms in people with Alzheimer's and Lewy body dementia: 12-year longitudinal cohort study. Br J Psychiatry. 2020 Jan;216(1):43-48. doi: 10.1192/bjp.2019.195.

    PubMed 31506117

  • Faeo SE, Husebo BS, Bruvik FK, Tranvag O. "We live as good a life as we can, in the situation we're in" - the significance of the home as perceived by persons with dementia. BMC Geriatr. 2019 Jun 6;19(1):158. doi: 10.1186/s12877-019-1171-6.

    PubMed 31170916

  • Husebo BS, Heintz HL, Berge LI, Owoyemi P, Rahman AT, Vahia IV. Sensing Technology to Monitor Behavioral and Psychological Symptoms and to Assess Treatment Response in People With Dementia. A Systematic Review. Front Pharmacol. 2020 Feb 4;10:1699. doi: 10.3389/fphar.2019.01699. eCollection 2019.

    PubMed 32116687

  • Vahia IV, Forester BP. Motion mapping in humans as a biomarker for psychiatric disorders. Neuropsychopharmacology. 2019 Jan;44(1):231-232. doi: 10.1038/s41386-018-0205-7. No abstract available.

    PubMed 30214060

  • Au-Yeung WM, Miller L, Beattie Z, May R, Cray HV, Kabelac Z, Katabi D, Kaye J, Vahia IV. Monitoring Behaviors of Patients With Late-Stage Dementia Using Passive Environmental Sensing Approaches: A Case Series. Am J Geriatr Psychiatry. 2022 Jan;30(1):1-11. doi: 10.1016/j.jagp.2021.04.008. Epub 2021 Apr 22.

    PubMed 34039534

  • Torrado JC, Husebo BS, Allore HG, Erdal A, Faeo SE, Reithe H, Forsund E, Tzoulis C, Patrascu M. Digital phenotyping by wearable-driven artificial intelligence in older adults and people with Parkinson's disease: Protocol of the mixed method, cyclic ActiveAgeing study. PLoS One. 2022 Oct 14;17(10):e0275747. doi: 10.1371/journal.pone.0275747. eCollection 2022.

    PubMed 36240173

  • Schuurmans AAT, de Looff P, Nijhof KS, Rosada C, Scholte RHJ, Popma A, Otten R. Validity of the Empatica E4 Wristband to Measure Heart Rate Variability (HRV) Parameters: a Comparison to Electrocardiography (ECG). J Med Syst. 2020 Sep 23;44(11):190. doi: 10.1007/s10916-020-01648-w.

    PubMed 32965570

  • Toften S, Pallesen S, Hrozanova M, Moen F, Gronli J. Validation of sleep stage classification using non-contact radar technology and machine learning (Somnofy(R)). Sleep Med. 2020 Nov;75:54-61. doi: 10.1016/j.sleep.2020.02.022. Epub 2020 Mar 6.

    PubMed 32853919

  • Jorm AF. The Informant Questionnaire on cognitive decline in the elderly (IQCODE): a review. Int Psychogeriatr. 2004 Sep;16(3):275-93. doi: 10.1017/s1041610204000390.

    PubMed 15559753

  • Reisberg B. Functional assessment staging (FAST). Psychopharmacol Bull. 1988;24(4):653-9. No abstract available.

    PubMed 3249767

  • Evensen S, Hylen Ranhoff A, Lydersen S, Saltvedt I. The delirium screening tool 4AT in routine clinical practice: prediction of mortality, sensitivity and specificity. Eur Geriatr Med. 2021 Aug;12(4):793-800. doi: 10.1007/s41999-021-00489-1. Epub 2021 Apr 4.

    PubMed 33813725

  • Thorpe O, McCabe E, Herrero EM, Doyle WO, Dillon A, Edge L, Flynn S, Mullen A, Davis A, Molamphy A, Kirwan A, Briggs R, Lavan AH, Shields D, McMahon G, Hennessy A, Kennedy U, Staunton P, Kidney E, Yeung SJ, Glynn D, Horgan F, Cunningham C, Romero-Ortuno R. Scoring the Clinical Frailty Scale in the Emergency Department: The Home FIRsT Experience. J Frailty Sarcopenia Falls. 2022 Jun 1;7(2):95-100. doi: 10.22540/JFSF-07-095. eCollection 2022 Jun.

    PubMed 35775090

Questions about this trial

What is this clinical trial studying?

An observational study of Dementia, run by University of Bergen at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lydia Dawn Boyle, MSc, DPT (+4740518081, lydia.boyle@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06032091, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.

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