xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06032091</url>
    </required_header>
    <id_info>
      <org_study_id>F-12829-D10484</org_study_id>
      <nct_id>NCT06032091</nct_id>
    </id_info>
    <brief_title>Digital Phenotyping for Changes in Activity at the End of Life in People With Dementia</brief_title>
    <acronym>DIPHDEM</acronym>
    <official_title>Digital Phenotyping for Changes in Activity at the End of Life in People With Dementia: an Observational Trial Based on Sensing Technology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Bergen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Helse Vest</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Haukeland University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Haraldsplass Deaconess Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Bergen Red Cross Nursing Home</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Bergen</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background:&#xD;
  &#xD;
        Almost 90% of people with dementia develop serious symptoms such as apathy, agitation, pain,&#xD;
        and sleep disturbances. Movement and participation in daily activities also decrease&#xD;
        dramatically over time. Traditional measures for these symptoms are usually in the form of a&#xD;
        questionnaire and are not very accurate. Technology, such as a smartwatch, can be an&#xD;
        effective tool for complementing traditional measures. Currently, there are few studies which&#xD;
        look at activity and symptom measurements at the end-of-life. This makes results from this&#xD;
        study extremely valuable for future care decisions, especially for people which may not be&#xD;
        able to communicate their needs during the end-of-life period.&#xD;
  &#xD;
        Method/Design:&#xD;
  &#xD;
        DIgital PHenotyping in DEMentia (DIPH.DEM), a 3-year cross-sectional observational study&#xD;
        (N=50), will look at activities, apathy, agitation, and sleep disturbances using sensing&#xD;
        technologies to monitor participants at the end of life. The objective of the study is to use&#xD;
        a smartwatch and wireless radar (bedside) device (Somnofy), in addition to validated&#xD;
        assessment tools to describe the activity patterns for patients with dementia at the end of&#xD;
        life (baseline and every 6.months). We hypothesize that this will enable better estimation of&#xD;
        time of death, facilitating discussion surrounding improvement of end-of-life interventions&#xD;
        and directives.&#xD;
  &#xD;
        Discussion:&#xD;
  &#xD;
        The use of sensors (smartwatch and wireless beside device) can provide valuable knowledge on&#xD;
        living and dying with dementia, improve end-of-life directives, and provide guidance for&#xD;
        timely, appropriate interventions, including referral to palliative services.&#xD;
  &#xD;
        Impact on society:&#xD;
  &#xD;
        DIPH.DEM has the potential to enable more timely, precise, and quality care for people with&#xD;
        dementia living at home, in nursing homes, and hospitals.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        About 90% of people with dementia develop behavioral and psychological symptoms such as&#xD;
        agitation, depression and psychosis. In addition, their activity levels decrease over time.&#xD;
        Traditional outcome measures can capture physical, mental and social activities of clinical&#xD;
        conditions, but usually have low validity.The use of sensor technology in people with&#xD;
        dementia is currently poorly validated. DIPH.DEM will examine whether digital tools such as a&#xD;
        smartwatch and Somnofy (radar installation) can provide objective measurements of the&#xD;
        patient's activities and symptoms throughout the nursing home/hospital stay, including the&#xD;
        end of life phase. The participants are people with dementia, &gt;64 years, who have lived in a&#xD;
        nursing home for &gt;1 year. A selection of traditional tools and sensor data is collected at&#xD;
        baseline and every 6 months (7 days continuous monitoring). If the participant has a&#xD;
        significant change in health status, we will begin with continuous sensor measurements until&#xD;
        the end of life (up to 12 weeks). DIPH.DEM can provide valuable information on activity&#xD;
        development and symptom presentation toward the end of life in people with dementia. Informal&#xD;
        caregivers (usually a family member) will be included to assist with the outcome measures&#xD;
        within the study. Participants will be recruited from the Health Region West Norway and&#xD;
        Bergen Municipality (sampling method is by invitation to volunteer). All consent procedures&#xD;
        will be developed in accordance with Norwegian law.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">February 2026</completion_date>
    <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Edmonton Symptom Assessment System (ESAS)</measure>
      <time_frame>Baseline and every 6.months (up to one year)</time_frame>
      <description>Symptom assessment for palliative care period and the end of life period, with added items: death rattle, dyspnea, sleep disturbances, emesis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Activities of Daily Living (ADL)</measure>
      <time_frame>Baseline and every 6.months (up to one year)</time_frame>
      <description>Personal functional daily activities such as toileting, eating, self-care, movement/ambulation, transfers, bathing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Digital biomarker estimations for apathy, agitation, pain, and sleep disturbances</measure>
      <time_frame>Baseline and every 6.months (up to one year), continuous up to 12 weeks if a serious health event occurs</time_frame>
      <description>Estimation of activity changes and selected behavioral disturbances resulting from the combined digital phenotype modeling</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)</measure>
      <time_frame>Baseline and every 6.months (up to one year)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mobilization, Observation, Behavioral, Intensity Dementia (MOBID-2)</measure>
      <time_frame>Baseline and every 6.months (up to one year)</time_frame>
      <description>Measurement of pain specific to a dementia population.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>InterRai-Palliative Care (InterRai-PC)</measure>
      <time_frame>Baseline and every 6.months (up to one year)</time_frame>
      <description>Oral health section only/specific of the InterRai-PC</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Digital secondary outcomes</measure>
      <time_frame>Baseline and every 6.months (up to one year)</time_frame>
      <description>Device-native scores for activity and sleep.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Chart review</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Mini-Mental-State Examination (MMSE)</measure>
      <time_frame>Baseline</time_frame>
      <description>Classification of disease, &lt;20 (mild-severe dementia)</description>
    </other_outcome>
    <other_outcome>
      <measure>Short Form of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)</measure>
      <time_frame>Baseline</time_frame>
      <description>Classification of disease and cognitive impairment</description>
    </other_outcome>
    <other_outcome>
      <measure>Functional Assessment Staging Tool (FAST)</measure>
      <time_frame>Baseline</time_frame>
      <description>Staging of disease and associated with mortality risk measurement.</description>
    </other_outcome>
    <other_outcome>
      <measure>General Medical Health Rating Scale (GMHR)</measure>
      <time_frame>Baseline</time_frame>
      <description>Mortality risk measure for general wellbeing.</description>
    </other_outcome>
    <other_outcome>
      <measure>4 A's Test for Delirium (4AT)</measure>
      <time_frame>Baseline</time_frame>
      <description>Distinction between dementia and delirium for inclusion to study.</description>
    </other_outcome>
    <other_outcome>
      <measure>Clinical Frailty Scale (CFS)</measure>
      <time_frame>Baseline</time_frame>
      <description>Mortality risk measure for general wellbeing.</description>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Dementia</condition>
    <arm_group>
      <arm_group_label>Participants</arm_group_label>
      <description>Persons with dementia</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>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.</description>
      <arm_group_label>Participants</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Older adults with dementia or cognitive impairment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  People with dementia (Mini-Mental-State Examination (MMSE) &lt;20 or have a likely&#xD;
               diagnosis of dementia based on a medical review)&#xD;
  &#xD;
            -  Hospital (admitted for &gt;3 days)&#xD;
  &#xD;
            -  Nursing home (where they have resided for &gt;1 year)&#xD;
  &#xD;
            -  &gt;64 years old&#xD;
  &#xD;
            -  Score of &lt;4 on the 4 A's Test for Delirium (4AT) will be required for inclusion (no&#xD;
               delirium)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People without dementia or cognitive impairment&#xD;
  &#xD;
            -  People that are considered already in a health status emergency (&lt; 6 weeks to live)&#xD;
  &#xD;
            -  People that have lived &lt;1 year in the nursing home&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bettina S Husebo, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Monica Patrascu, PhD, Eng</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lydia Boyle, MSc, DPT</last_name>
      <role>Study Chair</role>
      <affiliation>University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lydia Dawn Boyle, MSc, DPT</last_name>
      <phone>+4740518081</phone>
      <email>lydia.boyle@uib.no</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Monica Patrascu, PhD, Eng</last_name>
      <phone>+4755588501</phone>
      <email>monica.patrascu@uib.no</email>
    </overall_contact_backup>
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      <citation>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.</citation>
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      <PMID>28042071</PMID>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>end-of-life care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dementia</mesh_term>
      <mesh_term>Death</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_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.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06032091
  org study id: F-12829-D10484
  nct id: NCT06032091
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Edmonton Symptom Assessment System (ESAS)
  time frame: Baseline and every 6.months (up to one year)
  description: Symptom assessment for palliative care period and the end of life period, with added items: death rattle, dyspnea, sleep disturbances, emesis.
  measure: Activities of Daily Living (ADL)
  time frame: Baseline and every 6.months (up to one year)
  description: Personal functional daily activities such as toileting, eating, self-care, movement/ambulation, transfers, bathing.
  measure: 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
  description: Estimation of activity changes and selected behavioral disturbances resulting from the combined digital phenotype modeling
  measure: Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)
  time frame: Baseline and every 6.months (up to one year)
  description: 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.
  measure: Mobilization, Observation, Behavioral, Intensity Dementia (MOBID-2)
  time frame: Baseline and every 6.months (up to one year)
  description: Measurement of pain specific to a dementia population.
  measure: InterRai-Palliative Care (InterRai-PC)
  time frame: Baseline and every 6.months (up to one year)
  description: Oral health section only/specific of the InterRai-PC
  measure: Digital secondary outcomes
  time frame: Baseline and every 6.months (up to one year)
  description: Device-native scores for activity and sleep.
  measure: Chart review
  time frame: Baseline
  description: 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.
  measure: Mini-Mental-State Examination (MMSE)
  time frame: Baseline
  description: Classification of disease, <20 (mild-severe dementia)
  measure: Short Form of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
  time frame: Baseline
  description: Classification of disease and cognitive impairment
  measure: Functional Assessment Staging Tool (FAST)
  time frame: Baseline
  description: Staging of disease and associated with mortality risk measurement.
  measure: General Medical Health Rating Scale (GMHR)
  time frame: Baseline
  description: Mortality risk measure for general wellbeing.
  measure: 4 A's Test for Delirium (4AT)
  time frame: Baseline
  description: Distinction between dementia and delirium for inclusion to study.
  measure: Clinical Frailty Scale (CFS)
  time frame: Baseline
  description: Mortality risk measure for general wellbeing.
  arm group label: Participants
  description: Persons with dementia
  intervention type: Other
  intervention name: No intervention
  description: 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.
  arm group label: Participants
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bettina S Husebo, MD, PhD
  role: Study Director
  affiliation: University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center
  last name: Monica Patrascu, PhD, Eng
  role: Principal Investigator
  affiliation: University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center
  last name: Lydia Boyle, MSc, DPT
  role: Study Chair
  affiliation: University of Bergen, Center for Elderly and Nursing Home Medicine, Neuro-SysMed Center
  last name: Lydia Dawn Boyle, MSc, DPT
  phone: +4740518081
  email: lydia.boyle@uib.no
  last name: Monica Patrascu, PhD, Eng
  phone: +4755588501
  email: monica.patrascu@uib.no
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  PMID: 35114146
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  responsible party type: Sponsor
  mesh term: Dementia
  mesh term: Death
  sharing ipd: Undecided
  ipd 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.