<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/NCT04474730</url>
  </required_header>
  <id_info>
    <org_study_id>51563</org_study_id>
    <nct_id>NCT04474730</nct_id>
  </id_info>
  <brief_title>Physical Activity Monitoring Among BMT Patients</brief_title>
  <official_title>Physical Activity Monitoring Among Bone Marrow Transplant Patients: An Apple Watch Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ming-Yuan Chih</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the feasibility of an apple watch-based application to promote&#xD;
      physical activity among bone marrow transplant (BMT) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research objective is to test the feasibility of using an Apple Watch-based system with&#xD;
      the capacity to monitor BMT patients' physical activity and other patient reported outcomes&#xD;
      at an ongoing basis within the inpatient BMT setting at the University of Kentucky Markey&#xD;
      Cancer Center (UKMCC). The central hypothesis in this project is that the Apple Watch-based&#xD;
      system designed based on user-centered design principles and the proposed study method will&#xD;
      yield high feasibility.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>In this study, we conduct a small randomized controlled trial to study the feasibility of an Apple Watch app developed to monitor bone marrow transplant patients' physical activities at their initial hospitalization.</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility - Recruitment</measure>
    <time_frame>The day of recruitment</time_frame>
    <description>Recruitment rate: the percentage of eligible patients who are enrolled</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility - Study completion</measure>
    <time_frame>From enrollment to 30 day post transplant or at hospital discharge</time_frame>
    <description>Study completion rate - The percentage of enrolled patients who completed the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility - Usability</measure>
    <time_frame>30 day post transplant or at hospital discharge</time_frame>
    <description>A survey scale (User version - Mobile Application Rating Scale or uMARS) will be used to measure usability. uMARS scale score is calculated by averaging the likert scale answers, which range from 0 to 5. The uMARS score of 3.5 or higher is deemed to be acceptable usability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>30 days post intervention or at hospital discharge</time_frame>
    <description>Steps</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Bone Marrow Transplantation</condition>
  <arm_group>
    <arm_group_label>Watch Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Watch+App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BMT Physical Activity app</intervention_name>
    <description>This app sends reminders to patients, collect activity data from Apple Watch, and allow patients to submit symptoms.</description>
    <arm_group_label>Watch+App</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Watch Only</intervention_name>
    <description>A locked Apple Watch will be used to collect physical activity data from the Watch Only patients.</description>
    <arm_group_label>Watch Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Design Phase: Post 100 days BMT patients, family caregivers and providers&#xD;
&#xD;
          -  Trial Phase: New BMT patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 18 years old;&#xD;
&#xD;
          -  can't communicate, read or write in English;&#xD;
&#xD;
          -  having any communicable infection or showing the signs of it, including coughing,&#xD;
             fever, or rash;&#xD;
&#xD;
          -  and incapable of completing the assigned research activities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming-Yuan Chih, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky Markey Cancer Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>October 28, 2022</last_update_submitted>
  <last_update_submitted_qc>October 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Ming-Yuan Chih</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Bone Marrow Transplantation</keyword>
  <keyword>Mobile Health</keyword>
  <keyword>Symptom Management</keyword>
  <keyword>Physical Activity</keyword>
  <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/NCT04474730
org study id: 51563
nct id: NCT04474730
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study aims to evaluate the feasibility of an apple watch-based application to promote
      physical activity among bone marrow transplant (BMT) patients.
The research objective is to test the feasibility of using an Apple Watch-based system with
      the capacity to monitor BMT patients' physical activity and other patient reported outcomes
      at an ongoing basis within the inpatient BMT setting at the University of Kentucky Markey
      Cancer Center (UKMCC). The central hypothesis in this project is that the Apple Watch-based
      system designed based on user-centered design principles and the proposed study method will
      yield high feasibility.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this study, we conduct a small randomized controlled trial to study the feasibility of an Apple Watch app developed to monitor bone marrow transplant patients' physical activities at their initial hospitalization.
primary purpose: Device Feasibility
masking: Single (Outcomes Assessor)
measure: Feasibility - Recruitment
time frame: The day of recruitment
description: Recruitment rate: the percentage of eligible patients who are enrolled
measure: Feasibility - Study completion
time frame: From enrollment to 30 day post transplant or at hospital discharge
description: Study completion rate - The percentage of enrolled patients who completed the study
measure: Feasibility - Usability
time frame: 30 day post transplant or at hospital discharge
description: A survey scale (User version - Mobile Application Rating Scale or uMARS) will be used to measure usability. uMARS scale score is calculated by averaging the likert scale answers, which range from 0 to 5. The uMARS score of 3.5 or higher is deemed to be acceptable usability.
measure: Physical Activity
time frame: 30 days post intervention or at hospital discharge
description: Steps
arm group label: Watch Only
arm group type: Active Comparator
arm group label: Watch+App
arm group type: Experimental
intervention type: Device
intervention name: BMT Physical Activity app
description: This app sends reminders to patients, collect activity data from Apple Watch, and allow patients to submit symptoms.
arm group label: Watch+App
intervention type: Other
intervention name: Watch Only
description: A locked Apple Watch will be used to collect physical activity data from the Watch Only patients.
arm group label: Watch Only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ming-Yuan Chih, PhD
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Ming-Yuan Chih
investigator title: Assistant Professor
sharing ipd: No