<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/NCT04499729</url>
  </required_header>
  <id_info>
    <org_study_id>R44MH114725</org_study_id>
    <nct_id>NCT04499729</nct_id>
  </id_info>
  <brief_title>Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation</brief_title>
  <official_title>Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adaptive Health, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Adaptive Health, Inc</source>
  <oversight_info>
    <has_dmc>Yes</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 overarching aim of the proposed project is to conduct a pragmatic, quality improvement&#xD;
      evaluation of the IntelliCare Platform for improving processes of care in the Rush&#xD;
      Collaborative Care program, and improving patient population depression outcomes, to&#xD;
      determine the long-term utility of IntelliCare for Rush.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a pragmatic, system-wide rollout quality improvement evaluation design&#xD;
      displayed in Figure 1. The Rush IRB has waived consent for this quality improvement trial.&#xD;
      Data from the EHR will be used beginning December 1, 2019. The first care manager (CM) will&#xD;
      begin enrolling patients into IntelliCare in September, 2020. Additional CMs will begin using&#xD;
      IntelliCare at approximately 3 month intervals. In September 2021, support for IntelliCare&#xD;
      from the evaluation team will be withdrawn, to examine the sustainability of the IntelliCare&#xD;
      Platform.&#xD;
&#xD;
      Patients Data from all patients, aged 18 or older, enrolled collaborative care from December&#xD;
      1, 2019 through August 31, 2022 will be used to evaluate the IntelliCare service. All CCT&#xD;
      patients who are 18 or older, and have a smartphone will be offered enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The recruitment site (Rush University Medical Center Collaborative Care Program) redefined&#xD;
    their service objectives such that IntelliCare was no longer a good fit.&#xD;
  </why_stopped>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Actual">May 1, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>We will utilize a pragmatic, system-wide rollout quality improvement evaluation design. Data from patients in the Rush Collaborative Care service will be used beginning Dec 1, 2019. The first care manager will begin offering IntelliCare as part of the collaborative care service in September, 2020, and one additional care manager will begin offering IntelliCare to patients every 3 months</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>Up to 20 Months</time_frame>
    <description>Patient Health Questionnaire-9 (PHQ-9) assessment for depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of assessments</measure>
    <time_frame>Up to 20 Months</time_frame>
    <description>Number of Patient Health Questionnaire (PHQ-9) assessments acquired in the EHR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>First to last assessment</measure>
    <time_frame>Up to 20 Months</time_frame>
    <description>Time from first to last PHQ-9</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">318</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TAU will be the treatment that is provided through the Rush Collaborative Care program as part of their service</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IntelliCare</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be offered IntelliCare as part of their care in the Rush Collaborative Care service. Patients who agree will download the IntelliCare app, which provides self management and collects symptom self-report data. Symptom severity scores are displayed to the care manager, allowing them to manage the patient's care. The app also provides a secure messaging service for communication between the care manager and the patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IntelliCare</intervention_name>
    <description>IntelliCare provides self management and collects symptom self-report data. Symptom severity scores are displayed to the care manager, allowing them to manage the patient's care. The app also provides a secure messaging service for communication between the care manager and the patient.</description>
    <arm_group_label>IntelliCare</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as Usual (TAU)</intervention_name>
    <description>Treatment as usual in the Rush Collaborative Care service</description>
    <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in Rush Collaborative Care service&#xD;
&#xD;
          -  Owns a personal smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Carolyn MacIver</last_name>
    <role>Principal Investigator</role>
    <affiliation>Adaptive Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>November 22, 2021</last_update_submitted>
  <last_update_submitted_qc>November 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2021</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>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>There is not current plan to share IPD outside the research team.</ipd_description>
  </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/NCT04499729
org study id: R44MH114725
nct id: NCT04499729
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The overarching aim of the proposed project is to conduct a pragmatic, quality improvement
      evaluation of the IntelliCare Platform for improving processes of care in the Rush
      Collaborative Care program, and improving patient population depression outcomes, to
      determine the long-term utility of IntelliCare for Rush.
This study is a pragmatic, system-wide rollout quality improvement evaluation design
      displayed in Figure 1. The Rush IRB has waived consent for this quality improvement trial.
      Data from the EHR will be used beginning December 1, 2019. The first care manager (CM) will
      begin enrolling patients into IntelliCare in September, 2020. Additional CMs will begin using
      IntelliCare at approximately 3 month intervals. In September 2021, support for IntelliCare
      from the evaluation team will be withdrawn, to examine the sustainability of the IntelliCare
      Platform.

      Patients Data from all patients, aged 18 or older, enrolled collaborative care from December
      1, 2019 through August 31, 2022 will be used to evaluate the IntelliCare service. All CCT
      patients who are 18 or older, and have a smartphone will be offered enrollment.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: We will utilize a pragmatic, system-wide rollout quality improvement evaluation design. Data from patients in the Rush Collaborative Care service will be used beginning Dec 1, 2019. The first care manager will begin offering IntelliCare as part of the collaborative care service in September, 2020, and one additional care manager will begin offering IntelliCare to patients every 3 months
primary purpose: Health Services Research
masking: None (Open Label)
measure: Depression
time frame: Up to 20 Months
description: Patient Health Questionnaire-9 (PHQ-9) assessment for depression
measure: Number of assessments
time frame: Up to 20 Months
description: Number of Patient Health Questionnaire (PHQ-9) assessments acquired in the EHR
measure: First to last assessment
time frame: Up to 20 Months
description: Time from first to last PHQ-9
arm group label: Treatment as Usual (TAU)
arm group type: Active Comparator
description: TAU will be the treatment that is provided through the Rush Collaborative Care program as part of their service
arm group label: IntelliCare
arm group type: Experimental
description: Patients will be offered IntelliCare as part of their care in the Rush Collaborative Care service. Patients who agree will download the IntelliCare app, which provides self management and collects symptom self-report data. Symptom severity scores are displayed to the care manager, allowing them to manage the patient's care. The app also provides a secure messaging service for communication between the care manager and the patient.
intervention type: Device
intervention name: IntelliCare
description: IntelliCare provides self management and collects symptom self-report data. Symptom severity scores are displayed to the care manager, allowing them to manage the patient's care. The app also provides a secure messaging service for communication between the care manager and the patient.
arm group label: IntelliCare
intervention type: Behavioral
intervention name: Treatment as Usual (TAU)
description: Treatment as usual in the Rush Collaborative Care service
arm group label: Treatment as Usual (TAU)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carolyn MacIver
role: Principal Investigator
affiliation: Adaptive Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
sharing ipd: Undecided
ipd description: There is not current plan to share IPD outside the research team.