<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/NCT03038841</url>
  </required_header>
  <id_info>
    <org_study_id>PC 16/16</org_study_id>
    <nct_id>NCT03038841</nct_id>
  </id_info>
  <brief_title>Mobile Health Technology for Palliative Care Patients</brief_title>
  <official_title>Mobile Health Technologies for Palliative Care Patients at the Interface of In-patient to Out-patient Care: A Feasibility Study Aiming to Early Predict Deterioration of Patient's Health Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swiss Academy of Medical Sciences (SAMS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</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>
      To test the potential and acceptance of wireless activity tracking in palliative care&#xD;
      patients leaving hospital care. Explorative study, collaboration project of the Clinic of&#xD;
      Radiation-Oncology, University Hospital Zurich and the Wearable Computing Laboratory, Swiss&#xD;
      Federal Institut of Technology. Patients receive a tracking bracelet and a smart phone in&#xD;
      order to gather objective physical activity parameters as step count, sleep duration, heart&#xD;
      rate, social activity patterns (e.g. making calls) as well as subjective ratings of pain and&#xD;
      distress. Quality of life (QoL) will be captured by paper questionnaire. Correlations between&#xD;
      patients' physical activity patterns and the pain and distress level assessed from electronic&#xD;
      scales as well as QoL-questionnaire will be performed. Acceptance will be evaluated by&#xD;
      quantitative questionnaires and interviews. The proposed study is meant to be preparatory&#xD;
      work for an intervention study to test the effect of wireless monitoring of palliative care&#xD;
      patients on fostering early interventions for symptom relief and support of QoL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">May 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Weeks</target_duration>
  <primary_outcome>
    <measure>Feasibility (time of complete data transfer in weeks)</measure>
    <time_frame>12 weeks</time_frame>
    <description>time of complete data transfer in weeks</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Metastatic Cancer</condition>
  <condition>Mobile Health</condition>
  <condition>Chronic Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mobile Health</intervention_name>
    <description>Patients discharged from hospital will be equipped with a tracking bracelet and a smart phone</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized at one of the wards of the Clinic of Radiation-Oncology University&#xD;
        Hospital Zurich, including a ward of specialized Palliative Care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  established diagnosis of metastatic cancer or other severe illness with limited&#xD;
             life-expectancy (physicians guess &lt;12 months, &gt; 8 weeks)&#xD;
&#xD;
          -  Karnofsky Index ≥50%&#xD;
&#xD;
          -  ECOG≤ 2&#xD;
&#xD;
          -  aged &gt; 18 years&#xD;
&#xD;
          -  passed a short handling test with devices (tracking bracelet, smart phone)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  relevant cognitive impairment&#xD;
&#xD;
          -  insufficient knowledge of German language.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias Guckenberger, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Clinic of Radiation-Oncology USZ</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gerhard Tröster, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>ETH Zürich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gudrun Theile, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinic of Radiation-Oncology USZ</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gudrun Theile, MD</last_name>
    <phone>+41 44 255 5495</phone>
    <email>gudrun.theile@usz.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matea Pavic, MD</last_name>
    <phone>+41 44 255 3015</phone>
    <email>matea.pavic@usz.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clinic of Radiation-Oncology University Hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <state>Zurich</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gudrun Theile, MD</last_name>
      <phone>+41 44 255 5495</phone>
      <email>gudrun.theile@usz.ch</email>
    </contact>
    <contact_backup>
      <last_name>Matea Pavic, MD</last_name>
      <phone>+41 44 255 3015</phone>
      <email>matea.pavic@usz.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>June 20, 2017</last_update_submitted>
  <last_update_submitted_qc>June 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03038841
org study id: PC 16/16
nct id: NCT03038841
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To test the potential and acceptance of wireless activity tracking in palliative care
      patients leaving hospital care. Explorative study, collaboration project of the Clinic of
      Radiation-Oncology, University Hospital Zurich and the Wearable Computing Laboratory, Swiss
      Federal Institut of Technology. Patients receive a tracking bracelet and a smart phone in
      order to gather objective physical activity parameters as step count, sleep duration, heart
      rate, social activity patterns (e.g. making calls) as well as subjective ratings of pain and
      distress. Quality of life (QoL) will be captured by paper questionnaire. Correlations between
      patients' physical activity patterns and the pain and distress level assessed from electronic
      scales as well as QoL-questionnaire will be performed. Acceptance will be evaluated by
      quantitative questionnaires and interviews. The proposed study is meant to be preparatory
      work for an intervention study to test the effect of wireless monitoring of palliative care
      patients on fostering early interventions for symptom relief and support of QoL.
observational model: Other
time perspective: Prospective
measure: Feasibility (time of complete data transfer in weeks)
time frame: 12 weeks
description: time of complete data transfer in weeks
intervention type: Device
intervention name: Mobile Health
description: Patients discharged from hospital will be equipped with a tracking bracelet and a smart phone
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 105 Years
healthy volunteers: No
last name: Matthias Guckenberger, Prof
role: Study Chair
affiliation: Clinic of Radiation-Oncology USZ
last name: Gerhard Tröster, Prof
role: Study Chair
affiliation: ETH Zürich
last name: Gudrun Theile, MD
role: Principal Investigator
affiliation: Clinic of Radiation-Oncology USZ
last name: Gudrun Theile, MD
phone: +41 44 255 5495
email: gudrun.theile@usz.ch
last name: Matea Pavic, MD
phone: +41 44 255 3015
email: matea.pavic@usz.ch
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
responsible party type: Sponsor
mesh term: Chronic Disease
sharing ipd: No