<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/NCT03294512</url>
  </required_header>
  <id_info>
    <org_study_id>1050557</org_study_id>
    <nct_id>NCT03294512</nct_id>
  </id_info>
  <brief_title>Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform</brief_title>
  <acronym>iMAWDS</acronym>
  <official_title>Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform (iMAWDS Mobile HF Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intermountain Health Care, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Savvysherpa, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Intermountain Health Care, Inc.</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>
      The purpose of this study is to create a smartphone app that delivers the educational content&#xD;
      of the current Intermountain MAWDS* program and allows patients to enter and track their&#xD;
      MAWDS data within the app; and to determine if a broad-scale project can be conducted within&#xD;
      the limits of currently available technology. Information from this study will be used to&#xD;
      design a larger study that is powered to assess the association between data obtained via a&#xD;
      MAWDS app and heart failure outcomes.&#xD;
&#xD;
      (*MAWDS- Medications, Activity, Weight, Diet, Symptoms)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Intermountain Heart Institute will collaborate with Savvysherpa Inc to develop a&#xD;
      sensor-based digital platform based on MAWDS. (MAWDS is Intermountain's acronym that stands&#xD;
      for Medications, Activity, Weight, Diet, Symptoms; used across Intermountain Healthcare to&#xD;
      represent the most important concepts and skills to teach heart failure patients) This will&#xD;
      be used to deliver simple, home-based interventions via an app on the subject's iPhone. The&#xD;
      app will be programmed to send notifications to the subject to enter their MAWDS data and&#xD;
      perform a 6-minute walk test at specific time points during the study. Written informed&#xD;
      consent will be obtained from each subject prior to participation. A study team member will&#xD;
      register eligible subjects as well as assist them with the iPhone and HealthKit set-up and&#xD;
      train them on the app usage. Protocol-required information will be obtained from subject's&#xD;
      medical records (collected as part of their usual medical care). Subjects will be asked to&#xD;
      enter data into the MAWDS iPhone app at specified intervals for a period of 3 months. The&#xD;
      data, with the date and time it was entered, will be posted to a study-specific database.&#xD;
      Periodically, the MAWDS app will query activity data from HealthKit and post that to the same&#xD;
      database. Scheduled notifications will appear in the iPhone's Notification Center, reminding&#xD;
      the subject to use the app. To assess subject engagement, the app will collect and store&#xD;
      standard usage statistics provided by the iOS (e.g., number of times and duration the app is&#xD;
      used per day, number of data entries, etc). The subjects' electronic medical records will be&#xD;
      reviewed for a period of 3 months following enrollment, focused on healthcare utilization&#xD;
      (e.g., hospital readmissions, mortality, changes in Intermountain HF (heart failure) Risk&#xD;
      Score, etc). All information will be made part of the study-specific database. Follow-up&#xD;
      phone calls will be done, as needed, within the first 2 weeks after enrollment to remind&#xD;
      subjects to activate the app, ensure that the subjects are using the app appropriately, and&#xD;
      address any issues noted on monitoring the data collected via the app. Subjects will have no&#xD;
      other research-related clinic visits or in-person follow-up evaluations, other than the visit&#xD;
      for obtaining informed consent, registration and setting up of the app, and follow-up&#xD;
      telephone calls as needed. Upon completion of the study, the app on the subject's iPhone will&#xD;
      be disabled and Savvysherpa will disconnect the &quot;backend&quot; data capture. Data will no longer&#xD;
      be collected from the subject and his/her medical records will no longer be accessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">May 11, 2018</completion_date>
  <primary_completion_date type="Actual">May 11, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of patients utilizing the app.</measure>
    <time_frame>3 months</time_frame>
    <description>Data will be collected that shows the number of patients engaging with the app.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Heart Failure Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who are seen at Intermountain Medical Center with heart failure, based on the Intermountain-specific Heart Failure Identification and Risk Stratification, will be screened for this study. The Principal Investigator and/or his delegate will confirm the presence of heart failure, based on established standard of care criteria for diagnosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MAWDS data entry on app</intervention_name>
    <description>Utilize the smartphone app to enter their MAWDS (Medication, Activity, Weight, Diet, Symptoms) data</description>
    <arm_group_label>Heart Failure Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female &gt; 18 years of age&#xD;
&#xD;
          2. Ability to understand and sign a written informed consent form, which must be obtained&#xD;
             prior to initiation of any study procedures&#xD;
&#xD;
          3. Documentation of heart failure of any etiology, using standard of care criteria for&#xD;
             diagnosis, and based on clinical assessment of the Principal Investigator and/or his&#xD;
             delegate&#xD;
&#xD;
          4. Possess (and are comfortable using) an iPhone of appropriate age (model 5S or newer,&#xD;
             since these models have a motion coprocessor that can run iOS 8 or later, as needed to&#xD;
             run the app)&#xD;
&#xD;
          5. Willing and able to comply with the instructions for entering their MAWDS data into&#xD;
             the app installed in their iPhones&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Significant and/or severe co-morbidities, as assessed by the Principal Investigator&#xD;
             and/or his delegate&#xD;
&#xD;
          2. Currently in hospice care or planned discharge to hospice care at home or to a hospice&#xD;
             care facility&#xD;
&#xD;
          3. Inability to read and/or understand English (Non-English speaking and reading&#xD;
             participants will be excluded since the program requires a variety of communications,&#xD;
             not all of which have been validated in a language other than English).&#xD;
&#xD;
          4. Other conditions that in the opinion of the Principal Investigator and/or&#xD;
             Sub-Investigator may increase risk to the subject and/or compromise the quality of the&#xD;
             clinical trial&#xD;
&#xD;
          5. The Study Clinician(s) determine(s) that the subject is not eligible for participation&#xD;
             in this research study&#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>Kirk U Knowlton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>August 15, 2018</last_update_submitted>
  <last_update_submitted_qc>August 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2018</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>Heart Failure</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/NCT03294512
org study id: 1050557
nct id: NCT03294512
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to create a smartphone app that delivers the educational content
      of the current Intermountain MAWDS* program and allows patients to enter and track their
      MAWDS data within the app; and to determine if a broad-scale project can be conducted within
      the limits of currently available technology. Information from this study will be used to
      design a larger study that is powered to assess the association between data obtained via a
      MAWDS app and heart failure outcomes.

      (*MAWDS- Medications, Activity, Weight, Diet, Symptoms)
The Intermountain Heart Institute will collaborate with Savvysherpa Inc to develop a
      sensor-based digital platform based on MAWDS. (MAWDS is Intermountain's acronym that stands
      for Medications, Activity, Weight, Diet, Symptoms; used across Intermountain Healthcare to
      represent the most important concepts and skills to teach heart failure patients) This will
      be used to deliver simple, home-based interventions via an app on the subject's iPhone. The
      app will be programmed to send notifications to the subject to enter their MAWDS data and
      perform a 6-minute walk test at specific time points during the study. Written informed
      consent will be obtained from each subject prior to participation. A study team member will
      register eligible subjects as well as assist them with the iPhone and HealthKit set-up and
      train them on the app usage. Protocol-required information will be obtained from subject's
      medical records (collected as part of their usual medical care). Subjects will be asked to
      enter data into the MAWDS iPhone app at specified intervals for a period of 3 months. The
      data, with the date and time it was entered, will be posted to a study-specific database.
      Periodically, the MAWDS app will query activity data from HealthKit and post that to the same
      database. Scheduled notifications will appear in the iPhone's Notification Center, reminding
      the subject to use the app. To assess subject engagement, the app will collect and store
      standard usage statistics provided by the iOS (e.g., number of times and duration the app is
      used per day, number of data entries, etc). The subjects' electronic medical records will be
      reviewed for a period of 3 months following enrollment, focused on healthcare utilization
      (e.g., hospital readmissions, mortality, changes in Intermountain HF (heart failure) Risk
      Score, etc). All information will be made part of the study-specific database. Follow-up
      phone calls will be done, as needed, within the first 2 weeks after enrollment to remind
      subjects to activate the app, ensure that the subjects are using the app appropriately, and
      address any issues noted on monitoring the data collected via the app. Subjects will have no
      other research-related clinic visits or in-person follow-up evaluations, other than the visit
      for obtaining informed consent, registration and setting up of the app, and follow-up
      telephone calls as needed. Upon completion of the study, the app on the subject's iPhone will
      be disabled and Savvysherpa will disconnect the "backend" data capture. Data will no longer
      be collected from the subject and his/her medical records will no longer be accessed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: The number of patients utilizing the app.
time frame: 3 months
description: Data will be collected that shows the number of patients engaging with the app.
arm group label: Heart Failure Patients
arm group type: Experimental
description: Patients who are seen at Intermountain Medical Center with heart failure, based on the Intermountain-specific Heart Failure Identification and Risk Stratification, will be screened for this study. The Principal Investigator and/or his delegate will confirm the presence of heart failure, based on established standard of care criteria for diagnosis.
intervention type: Behavioral
intervention name: MAWDS data entry on app
description: Utilize the smartphone app to enter their MAWDS (Medication, Activity, Weight, Diet, Symptoms) data
arm group label: Heart Failure Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kirk U Knowlton, MD
role: Principal Investigator
affiliation: Intermountain Heart Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No