<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/NCT03242213</url>
  </required_header>
  <id_info>
    <org_study_id>6680</org_study_id>
    <nct_id>NCT03242213</nct_id>
  </id_info>
  <brief_title>Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement</brief_title>
  <official_title>Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advocate Health Care</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Advocate Health Care</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 current randomized controlled trial is a pilot study that will assess the effectiveness&#xD;
      and feasibility of a mobile phone application intervention. The objective is to determine&#xD;
      whether the use of a mobile health application for patient self-management of depression&#xD;
      improves patient-provider engagement for patients diagnosed with major depressive disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study will be a randomized, real-world effectiveness study. Patients diagnosed&#xD;
      with major depressive disorder starting a new prescription for an antidepressant monotherapy&#xD;
      will be eligible for participation. The study will enroll 40 patients (20 in an observational&#xD;
      arm of usual care and 20 with access to a mobile health application). No intervention will&#xD;
      occur in the usual care arm. The intervention in this study is a mobile health app, which&#xD;
      provides patients with a way to track emotional wellbeing and depression symptoms, set up&#xD;
      medication reminders, track adherence to medications, record side effects experienced, and&#xD;
      take surveys/tests to assess cognitive symptoms and depression. Patient reported outcomes and&#xD;
      clinical data will be collected at baseline and at study primary endpoint (18 weeks) to&#xD;
      assess changes over time and between groups for: patient-provider engagement, disease&#xD;
      severity, quality of life, employment productivity, cognitive function, resource utilization,&#xD;
      and medication adherence. Additionally, resource utilization will be assessed at the one year&#xD;
      time point. A Student's t test, if allowed for by the data distribution, will be used to&#xD;
      assess between group differences in patient reported outcome scales assessing&#xD;
      patient-provider engagement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Actual">September 9, 2019</completion_date>
  <primary_completion_date type="Actual">January 18, 2019</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient activation</measure>
    <time_frame>18 weeks</time_frame>
    <description>This will be assessed by the Patient Activation Measure, a validated scale that measures patient knowledge, skills and confidence in disease self-management in the primary care setting.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-provider engagement</measure>
    <time_frame>18 weeks</time_frame>
    <description>This will be assessed by the Patient-Provider Engagement Scale (PPES-7), an instrument developed for this study to measure patient knowledge, communication, and interaction with their provider specific to depression management.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression symptoms</measure>
    <time_frame>18 weeks</time_frame>
    <description>This patient reported outcome is assessed by the clinical depression severity. PHQ-9 scale, which scores each of the nine DSM-IV criteria as &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive dysfunction</measure>
    <time_frame>18 weeks</time_frame>
    <description>This patient reported outcome is assessed by the cognitive dysfunction PDQ-D scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication changes</measure>
    <time_frame>18 weeks</time_frame>
    <description>This outcome will be assessed by clinical data on the frequency and types of medication switches.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>18 weeks</time_frame>
    <description>This patient reported outcome is assessed by the quality of life WHO-5 survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization</measure>
    <time_frame>18 weeks</time_frame>
    <description>This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Long-term follow health care utilization</measure>
    <time_frame>1 year</time_frame>
    <description>This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of Care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mobile App</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of Care and Mobile App</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile App</intervention_name>
    <description>The intervention in this study is a mobile health app, which provides patients with a way to track emotional wellbeing and depression symptoms, set up medication reminders, track adherence to medications, record side effects experienced, and take surveys/tests to assess cognitive symptoms and depression.</description>
    <arm_group_label>Mobile App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 70&#xD;
&#xD;
          -  Ability to consent and participate in study (technical requirements for app: iPhone&#xD;
             version 5 or later, active data plan or regular WiFi access)&#xD;
&#xD;
          -  Diagnosis with major depressive disorder&#xD;
&#xD;
          -  PHQ-9 score greater than 5 at baseline&#xD;
&#xD;
          -  Recent (0-14 days) start on monotherapy depression medication (either new prescription&#xD;
             or a change from a previous medication)&#xD;
&#xD;
          -  Outpatient care provided by participating Advocate Medical Group clinics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis with major psychiatric disorder (e.g. bipolar disorder, manic depressive&#xD;
             disorder)&#xD;
&#xD;
          -  Contraindications to use of depression medications&#xD;
&#xD;
          -  Patients with treatment resistant depression [defined as patients who have not&#xD;
             responded to two or more separate different antidepressant monotherapy trials of&#xD;
             adequate dose and duration (6 weeks or longer) in the current depressive episode]&#xD;
&#xD;
          -  Considered at imminent risk for hospitalization due to severe depression in the&#xD;
             opinion of the treating physician&#xD;
&#xD;
          -  History of hospitalization due to major depressive disorder in prior 3 months&#xD;
&#xD;
          -  Significant risk of suicide according to the treating physician's clinical judgment or&#xD;
             previous suicide attempt in prior 6 months&#xD;
&#xD;
          -  History of response only to combination or augmentation therapy in current depressive&#xD;
             episode&#xD;
&#xD;
          -  Receipt of any investigational compound in prior 30 days (or five half-lives,&#xD;
             whichever is longer)&#xD;
&#xD;
          -  Current participation in another clinical study&#xD;
&#xD;
          -  Lack of functional English literacy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Kemp, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Advocate Health Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advocate Christ Medical Center</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>January 20, 2021</last_update_submitted>
  <last_update_submitted_qc>January 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Advocate Health Care</investigator_affiliation>
    <investigator_full_name>David Kemp</investigator_full_name>
    <investigator_title>Medical Director, Behavioral Health Service Line</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</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/NCT03242213
org study id: 6680
nct id: NCT03242213
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current randomized controlled trial is a pilot study that will assess the effectiveness
      and feasibility of a mobile phone application intervention. The objective is to determine
      whether the use of a mobile health application for patient self-management of depression
      improves patient-provider engagement for patients diagnosed with major depressive disorder.
This pilot study will be a randomized, real-world effectiveness study. Patients diagnosed
      with major depressive disorder starting a new prescription for an antidepressant monotherapy
      will be eligible for participation. The study will enroll 40 patients (20 in an observational
      arm of usual care and 20 with access to a mobile health application). No intervention will
      occur in the usual care arm. The intervention in this study is a mobile health app, which
      provides patients with a way to track emotional wellbeing and depression symptoms, set up
      medication reminders, track adherence to medications, record side effects experienced, and
      take surveys/tests to assess cognitive symptoms and depression. Patient reported outcomes and
      clinical data will be collected at baseline and at study primary endpoint (18 weeks) to
      assess changes over time and between groups for: patient-provider engagement, disease
      severity, quality of life, employment productivity, cognitive function, resource utilization,
      and medication adherence. Additionally, resource utilization will be assessed at the one year
      time point. A Student's t test, if allowed for by the data distribution, will be used to
      assess between group differences in patient reported outcome scales assessing
      patient-provider engagement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient activation
time frame: 18 weeks
description: This will be assessed by the Patient Activation Measure, a validated scale that measures patient knowledge, skills and confidence in disease self-management in the primary care setting.
measure: Patient-provider engagement
time frame: 18 weeks
description: This will be assessed by the Patient-Provider Engagement Scale (PPES-7), an instrument developed for this study to measure patient knowledge, communication, and interaction with their provider specific to depression management.
measure: Depression symptoms
time frame: 18 weeks
description: This patient reported outcome is assessed by the clinical depression severity. PHQ-9 scale, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
measure: Cognitive dysfunction
time frame: 18 weeks
description: This patient reported outcome is assessed by the cognitive dysfunction PDQ-D scale.
measure: Medication changes
time frame: 18 weeks
description: This outcome will be assessed by clinical data on the frequency and types of medication switches.
measure: Quality of Life
time frame: 18 weeks
description: This patient reported outcome is assessed by the quality of life WHO-5 survey.
measure: Health care utilization
time frame: 18 weeks
description: This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey.
measure: Long-term follow health care utilization
time frame: 1 year
description: This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey.
arm group label: Usual Care
arm group type: No Intervention
description: Standard of Care
arm group label: Mobile App
arm group type: Active Comparator
description: Standard of Care and Mobile App
intervention type: Behavioral
intervention name: Mobile App
description: The intervention in this study is a mobile health app, which provides patients with a way to track emotional wellbeing and depression symptoms, set up medication reminders, track adherence to medications, record side effects experienced, and take surveys/tests to assess cognitive symptoms and depression.
arm group label: Mobile App
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: David Kemp, MD, MS
role: Principal Investigator
affiliation: Advocate Health Care
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Advocate Health Care
investigator full name: David Kemp
investigator title: Medical Director, Behavioral Health Service Line
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
sharing ipd: No