<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/NCT04475718</url>
  </required_header>
  <id_info>
    <org_study_id>R43MD014923</org_study_id>
    <secondary_id>R43MD014923</secondary_id>
    <nct_id>NCT04475718</nct_id>
  </id_info>
  <brief_title>Fourth Trimester - A Web-based Tool for Postpartum Care to Address the Needs of Underserved Women</brief_title>
  <official_title>Fourth Trimester - A Web-based Tool for Postpartum Care to Address the Needs of Underserved Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carelon Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orange Square Design, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Carelon Research</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 postpartum period is a critical time for both maternal and child health, and more than&#xD;
      half of all maternal deaths occur postpartum, from one day to one year after birth. This poor&#xD;
      outcome is linked to the racial and ethnic disparities that disproportionately effects low&#xD;
      income and black women. To reduce the burden of the postpartum period for this population,&#xD;
      the goal of this project is to develop an accessible, targeted online tool designed to&#xD;
      address the needs of underserved women who are at greater risk for adverse postpartum&#xD;
      outcomes by providing the appropriate tools, knowledge and skills to improve postpartum&#xD;
      health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the United States, the postpartum period is a critical time for both maternal and child&#xD;
      health, the mortality rate is the highest among other developed, high income countries and&#xD;
      more than half of all maternal deaths occur postpartum, from one day to one year after birth.&#xD;
      This poor outcome is linked to the racial and ethnic disparities that disproportionately&#xD;
      effect black women who are 3-4 times more likely to experience maternal mortality than white&#xD;
      women. Recently, the American College of Obstetricians and Gynecologists recognized the&#xD;
      deficiencies in postpartum care and coined the term the 'fourth trimester' to mark the time&#xD;
      following the birth of the infant through the first 3-months postpartum, and updated its&#xD;
      recommendations to address these challenges. With impacts to health outcomes and healthcare&#xD;
      costs, there is a need to holistically bridge the gap for low-income and/or ethnically&#xD;
      diverse groups of women to address the physical, cultural, and knowledge barriers to&#xD;
      accessing quality postpartum care.&#xD;
&#xD;
      To improve the rate at which underserved women are disproportionately affected by maternal&#xD;
      mortality and morbidity, the investigators need to engage women leading into and specifically&#xD;
      during the postpartum period to identity areas of need, and to provide tools which reduce&#xD;
      barriers for women to get appropriate postpartum care. Technology offers innovative solutions&#xD;
      to challenges around equal information access. Pregnant women often turn to the internet to&#xD;
      find out more information about their health and their developing babies health. Yet, studies&#xD;
      find that mothers are not finding sufficient resources to match their postpartum needs.&#xD;
&#xD;
      To address this gap in care, this project aims to develop a mobile tool designed to increase&#xD;
      accessibility to information and practical approaches for addressing the complex needs of&#xD;
      women in this 'fourth trimester'. This tool will specifically focus on underserved women who&#xD;
      are at greatest risk of adverse postpartum outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 17, 2021</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 29, 2021</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>
    <intervention_model_description>Interviews were conducted with 24 pregnant and postpartum women. From this research and other activities, the investigators built a prototype program. Once the prototype was completed, the investigators conducted a clinical trial with 87 participants. The pre-test captured key outcome measures (resilience, stress, anxiety, depression, fear, knowledge, and variables related to COVID-19) and other descriptive variables. All participants who completed the pre-test were given access to the prototype mobile postpartum tool. Participants were asked to actively engage with the tool for 4 weeks, during which time they provided real-time user experience feedback. At the end of the 4-week period, the investigators conducted a post-test to measure change in outcomes.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline Resilience at 4 Weeks</measure>
    <time_frame>baseline, 4 weeks</time_frame>
    <description>Measured by the Connor-Davidson Resilience Scale, a 25-item scale covering 17 domains related to resiliency, used with a variety of populations, across a wide range of languages, racial/ethnic, and cultural groups. It has strong psychometric properties and validated short forms. Scoring of the scale is based on summing the total of all items, each of which is scored from 0-4. For the CD-RISC-25, the full range is from 0 to 100, with higher scores reflecting greater resilience.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Depressive Symptoms at 4 Weeks Using the Edinburgh Postnatal Depression Scale (EPDS)</measure>
    <time_frame>baseline, 4 weeks</time_frame>
    <description>The Edinburgh Postnatal Depression Scale (EPDS) will be used to assess depressive symptoms. The 10-question Edinburgh Postnatal Depression Scale (EPDS) is a valuable and efficient way of identifying patients at risk for perinatal depression. Scores range from 0-30. Higher scores indicate more depressive symptoms. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Social Support at 4 Weeks Using the MOS Social Support Survey</measure>
    <time_frame>baseline, 4 weeks</time_frame>
    <description>The MOS Social Support Survey will be used to assess overall social support and 4 subscales (Emotional/Informational Support; Tangible Support; Affectionate Support; Positive Social Interaction). The MOS Social Support Survey is a 19-item self-administered instrument. Items range from 1-5. The overall social support score is calculated as the mean response to all 19 items. Scores range from 19-95 with higher scores indicating more support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Parent Anxiety at 4 Weeks</measure>
    <time_frame>baseline, 4 weeks</time_frame>
    <description>The State-Trait Anxiety Inventory (STAI) is a measure of trait and state anxiety with 20 items for assessing trait anxiety and 20 for state anxiety. It has been validated for use with pregnant women. All items are rated on a 4-point scale (e.g., from &quot;Almost Never&quot; to &quot;Almost Always&quot;). The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-T and STAI-S subscales. Higher scores indicate greater anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From COVID-19 and Mental Health Impacts at 4 Weeks</measure>
    <time_frame>baseline, 4 weeks</time_frame>
    <description>The COVID-19 and Mental Health Impacts tool is a survey to help better understand how the novel coronavirus (COVID-19) pandemic is affecting people's emotional and mental health. A modified version of this instrument was used (removing Q1) to assess the impact of COVID-19 on study participants. All items are rated on a 5-point scale (from Strongly Disagree to Strongly Agree). The range of possible scores is 12-60, with higher scores indicating greater impact of COVID-19. The overall summary score is the sum of all items . While COVID-19 impact was not a formal endpoints, a descriptive analysis of this measure was conducted.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Postpartum Sadness</condition>
  <arm_group>
    <arm_group_label>Fourth Trimester Mobile Tool</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Fourth Trimester Mobile Tool</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fourth Trimester Mobile Tool</intervention_name>
    <description>A mobile web-based tool for underserved women in the fourth trimester. The mobile platform teaches self-efficacy, care management, and coping skills to help reduce major health risks and provide tools and resources to maintain mental health.</description>
    <arm_group_label>Fourth Trimester Mobile Tool</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18+;&#xD;
&#xD;
          -  Self-reported annual household income less than $39,500 (at least 75% of participants&#xD;
             - defined as &quot;low income&quot; household by the PEW Research Center);&#xD;
&#xD;
          -  Racial/ethnic minority (at least 75% of participants must be non-white, with at least&#xD;
             50% identifying as Black/African American);&#xD;
&#xD;
          -  Be a new or expectant mother - participants must be at least 28 weeks/6 months&#xD;
             pregnant (3rd trimester), and up to 6 months post-birth (no more than 10% of&#xD;
             participants will be currently pregnant, at least 90% will be postpartum).&#xD;
&#xD;
          -  Able to comply with the terms of the study (available time commitment, have internet&#xD;
             access; willing to comply with the specified focus groups and survey); and&#xD;
&#xD;
          -  Able to read, write and speak English (all research and product development activities&#xD;
             will be conducted in English due to budgetary constraints).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to comply with the Inclusion Criteria&#xD;
&#xD;
          -  Did not have a live birth (for those who are post-birth)&#xD;
&#xD;
          -  Self-reported major medical/health issue which would impact participants' health or&#xD;
             ability to participate.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristine Merz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orange Square Design, Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa Marceau, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carelon Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HealthCore</name>
      <address>
        <city>Watertown</city>
        <state>Massachusetts</state>
        <zip>02472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange Square Design Inc.</name>
      <address>
        <city>Pawtucket</city>
        <state>Rhode Island</state>
        <zip>02860</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <results_first_submitted>August 23, 2022</results_first_submitted>
  <results_first_submitted_qc>January 15, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2023</results_first_posted>
  <last_update_submitted>January 15, 2023</last_update_submitted>
  <last_update_submitted_qc>January 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Carelon Research</investigator_affiliation>
    <investigator_full_name>Lisa Marceau</investigator_full_name>
    <investigator_title>Staff Vice President, Digital Research Solutions</investigator_title>
  </responsible_party>
  <keyword>Postpartum health</keyword>
  <keyword>Fourth trimester</keyword>
  <keyword>Resiliency</keyword>
  <keyword>Health disparities</keyword>
  <keyword>Maternal health</keyword>
  <keyword>Mobile tools</keyword>
  <keyword>Human-centered design</keyword>
  <keyword>Digital health</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 29, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT04475718/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 25, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT04475718/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fourth Trimester Mobile Tool</title>
          <description>Fourth Trimester Mobile Tool&#xD;
Fourth Trimester Mobile Tool: A mobile web-based tool for underserved women in the fourth trimester. The mobile platform teaches self-efficacy, care management, and coping skills to help reduce major health risks and provide tools and resources to maintain mental health.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pre-Post Comparison</title>
          <description>Each participant was provided access to the Joyuus prototype for one month. Pilot participants were asked to complete a pretest, answer two real-time experience surveys while using the tool (visual identity and content), and complete a post-test one month after accessing the tool.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="87"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline Resilience at 4 Weeks</title>
        <description>Measured by the Connor-Davidson Resilience Scale, a 25-item scale covering 17 domains related to resiliency, used with a variety of populations, across a wide range of languages, racial/ethnic, and cultural groups. It has strong psychometric properties and validated short forms. Scoring of the scale is based on summing the total of all items, each of which is scored from 0-4. For the CD-RISC-25, the full range is from 0 to 100, with higher scores reflecting greater resilience.</description>
        <time_frame>baseline, 4 weeks</time_frame>
        <population>Analysis of change in outcome between baseline and after one-month will compare change in composite summary scale scores from pre-test to post-test for subjects in the ITT analysis set with data for both time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Pre-Post Comparison</title>
            <description>Each participant was provided access to the Joyuus prototype for one month. Pilot participants were asked to complete a pretest, answer two real-time experience surveys while using the tool (visual identity and content), and complete a post-test one month after accessing the tool.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Resilience at 4 Weeks</title>
          <description>Measured by the Connor-Davidson Resilience Scale, a 25-item scale covering 17 domains related to resiliency, used with a variety of populations, across a wide range of languages, racial/ethnic, and cultural groups. It has strong psychometric properties and validated short forms. Scoring of the scale is based on summing the total of all items, each of which is scored from 0-4. For the CD-RISC-25, the full range is from 0 to 100, with higher scores reflecting greater resilience.</description>
          <population>Analysis of change in outcome between baseline and after one-month will compare change in composite summary scale scores from pre-test to post-test for subjects in the ITT analysis set with data for both time points.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.57" lower_limit="25.45" upper_limit="27.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.29" lower_limit="27.11" upper_limit="29.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference of Post and Pre Total Score for Connor-Davidson Resilience Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.85" lower_limit=".92" upper_limit="2.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Preliminary Efficacy</non_inferiority_desc>
            <p_value>&lt;.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Depressive Symptoms at 4 Weeks Using the Edinburgh Postnatal Depression Scale (EPDS)</title>
        <description>The Edinburgh Postnatal Depression Scale (EPDS) will be used to assess depressive symptoms. The 10-question Edinburgh Postnatal Depression Scale (EPDS) is a valuable and efficient way of identifying patients at risk for perinatal depression. Scores range from 0-30. Higher scores indicate more depressive symptoms. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.</description>
        <time_frame>baseline, 4 weeks</time_frame>
        <population>87 participants completed baseline. 79 participants completed the post-test at 4 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>Fourth Trimester Mobile Tool</title>
            <description>Fourth Trimester Mobile Tool&#xD;
Fourth Trimester Mobile Tool: A mobile web-based tool for underserved women in the fourth trimester. The mobile platform teaches self-efficacy, care management, and coping skills to help reduce major health risks and provide tools and resources to maintain mental health.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Depressive Symptoms at 4 Weeks Using the Edinburgh Postnatal Depression Scale (EPDS)</title>
          <description>The Edinburgh Postnatal Depression Scale (EPDS) will be used to assess depressive symptoms. The 10-question Edinburgh Postnatal Depression Scale (EPDS) is a valuable and efficient way of identifying patients at risk for perinatal depression. Scores range from 0-30. Higher scores indicate more depressive symptoms. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.</description>
          <population>87 participants completed baseline. 79 participants completed the post-test at 4 weeks.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.90" lower_limit="7.74" upper_limit="10.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.70" lower_limit="7.56" upper_limit="9.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference of Post and Pre Total Score for Edinburgh Postnatal Depression Scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" lower_limit="-1.21" upper_limit="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Social Support at 4 Weeks Using the MOS Social Support Survey</title>
        <description>The MOS Social Support Survey will be used to assess overall social support and 4 subscales (Emotional/Informational Support; Tangible Support; Affectionate Support; Positive Social Interaction). The MOS Social Support Survey is a 19-item self-administered instrument. Items range from 1-5. The overall social support score is calculated as the mean response to all 19 items. Scores range from 19-95 with higher scores indicating more support.</description>
        <time_frame>baseline, 4 weeks</time_frame>
        <population>87 participants completed baseline. 79 participants completed the post-test at 4 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>Fourth Trimester Mobile Tool</title>
            <description>Fourth Trimester Mobile Tool&#xD;
Fourth Trimester Mobile Tool: A mobile web-based tool for underserved women in the fourth trimester. The mobile platform teaches self-efficacy, care management, and coping skills to help reduce major health risks and provide tools and resources to maintain mental health.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Social Support at 4 Weeks Using the MOS Social Support Survey</title>
          <description>The MOS Social Support Survey will be used to assess overall social support and 4 subscales (Emotional/Informational Support; Tangible Support; Affectionate Support; Positive Social Interaction). The MOS Social Support Survey is a 19-item self-administered instrument. Items range from 1-5. The overall social support score is calculated as the mean response to all 19 items. Scores range from 19-95 with higher scores indicating more support.</description>
          <population>87 participants completed baseline. 79 participants completed the post-test at 4 weeks.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.67" lower_limit="3.51" upper_limit="3.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.64" lower_limit="3.45" upper_limit="3.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference of Post and Pre overall summary score for MOS Social Support</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" lower_limit="-0.17" upper_limit="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Parent Anxiety at 4 Weeks</title>
        <description>The State-Trait Anxiety Inventory (STAI) is a measure of trait and state anxiety with 20 items for assessing trait anxiety and 20 for state anxiety. It has been validated for use with pregnant women. All items are rated on a 4-point scale (e.g., from &quot;Almost Never&quot; to &quot;Almost Always&quot;). The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-T and STAI-S subscales. Higher scores indicate greater anxiety.</description>
        <time_frame>baseline, 4 weeks</time_frame>
        <population>87 participants completed baseline. 79 participants completed the post-test at 4 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>Pre-Post Comparison</title>
            <description>Each participant was provided access to the Joyuus prototype for one month. Pilot participants were asked to complete a pretest, answer two real-time experience surveys while using the tool (visual identity and content), and complete a post-test one month after accessing the tool.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Parent Anxiety at 4 Weeks</title>
          <description>The State-Trait Anxiety Inventory (STAI) is a measure of trait and state anxiety with 20 items for assessing trait anxiety and 20 for state anxiety. It has been validated for use with pregnant women. All items are rated on a 4-point scale (e.g., from &quot;Almost Never&quot; to &quot;Almost Always&quot;). The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-T and STAI-S subscales. Higher scores indicate greater anxiety.</description>
          <population>87 participants completed baseline. 79 participants completed the post-test at 4 weeks.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.44" lower_limit="39.38" upper_limit="43.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.87" lower_limit="38.58" upper_limit="43.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference of Post and Pre Total score for State-Trait Anxiety Inventory</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.82" lower_limit="-2.35" upper_limit="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From COVID-19 and Mental Health Impacts at 4 Weeks</title>
        <description>The COVID-19 and Mental Health Impacts tool is a survey to help better understand how the novel coronavirus (COVID-19) pandemic is affecting people's emotional and mental health. A modified version of this instrument was used (removing Q1) to assess the impact of COVID-19 on study participants. All items are rated on a 5-point scale (from Strongly Disagree to Strongly Agree). The range of possible scores is 12-60, with higher scores indicating greater impact of COVID-19. The overall summary score is the sum of all items . While COVID-19 impact was not a formal endpoints, a descriptive analysis of this measure was conducted.</description>
        <time_frame>baseline, 4 weeks</time_frame>
        <population>87 participants completed baseline. 79 participants completed the post-test at 4 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>Fourth Trimester Mobile Tool</title>
            <description>Fourth Trimester Mobile Tool&#xD;
Fourth Trimester Mobile Tool: A mobile web-based tool for underserved women in the fourth trimester. The mobile platform teaches self-efficacy, care management, and coping skills to help reduce major health risks and provide tools and resources to maintain mental health.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From COVID-19 and Mental Health Impacts at 4 Weeks</title>
          <description>The COVID-19 and Mental Health Impacts tool is a survey to help better understand how the novel coronavirus (COVID-19) pandemic is affecting people's emotional and mental health. A modified version of this instrument was used (removing Q1) to assess the impact of COVID-19 on study participants. All items are rated on a 5-point scale (from Strongly Disagree to Strongly Agree). The range of possible scores is 12-60, with higher scores indicating greater impact of COVID-19. The overall summary score is the sum of all items . While COVID-19 impact was not a formal endpoints, a descriptive analysis of this measure was conducted.</description>
          <population>87 participants completed baseline. 79 participants completed the post-test at 4 weeks.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.34" lower_limit="27.34" upper_limit="31.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.65" lower_limit="27.55" upper_limit="31.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference of Post and Pre Total score for COVID-19 and Mental Health Impacts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" lower_limit="-1.53" upper_limit="1.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were collected for each participant at pre-test and post-test during the four week participation window.</time_frame>
      <desc>We surveyed participants on health-related measures at two timepoints (pre-test and post-test) and conducted weekly review of participant scores specifically for the Edinburgh Postnatal Depression Scale (EDPS) and the State-Trait Anxiety Inventory (STAI).&#xD;
A 0 for all-cause mortality indicates there were no cases of mortality during the study period.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fourth Trimester Mobile Tool</title>
          <description>Fourth Trimester Mobile Tool&#xD;
Fourth Trimester Mobile Tool: A mobile web-based tool for underserved women in the fourth trimester. The mobile platform teaches self-efficacy, care management, and coping skills to help reduce major health risks and provide tools and resources to maintain mental health.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Lisa Marceau</name_or_title>
      <organization>Orange Square Designs</organization>
      <phone>4014284197</phone>
      <email>lisa@orangesquare.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04475718
org study id: R43MD014923
secondary id: R43MD014923
nct id: NCT04475718
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The postpartum period is a critical time for both maternal and child health, and more than
      half of all maternal deaths occur postpartum, from one day to one year after birth. This poor
      outcome is linked to the racial and ethnic disparities that disproportionately effects low
      income and black women. To reduce the burden of the postpartum period for this population,
      the goal of this project is to develop an accessible, targeted online tool designed to
      address the needs of underserved women who are at greater risk for adverse postpartum
      outcomes by providing the appropriate tools, knowledge and skills to improve postpartum
      health.
In the United States, the postpartum period is a critical time for both maternal and child
      health, the mortality rate is the highest among other developed, high income countries and
      more than half of all maternal deaths occur postpartum, from one day to one year after birth.
      This poor outcome is linked to the racial and ethnic disparities that disproportionately
      effect black women who are 3-4 times more likely to experience maternal mortality than white
      women. Recently, the American College of Obstetricians and Gynecologists recognized the
      deficiencies in postpartum care and coined the term the 'fourth trimester' to mark the time
      following the birth of the infant through the first 3-months postpartum, and updated its
      recommendations to address these challenges. With impacts to health outcomes and healthcare
      costs, there is a need to holistically bridge the gap for low-income and/or ethnically
      diverse groups of women to address the physical, cultural, and knowledge barriers to
      accessing quality postpartum care.

      To improve the rate at which underserved women are disproportionately affected by maternal
      mortality and morbidity, the investigators need to engage women leading into and specifically
      during the postpartum period to identity areas of need, and to provide tools which reduce
      barriers for women to get appropriate postpartum care. Technology offers innovative solutions
      to challenges around equal information access. Pregnant women often turn to the internet to
      find out more information about their health and their developing babies health. Yet, studies
      find that mothers are not finding sufficient resources to match their postpartum needs.

      To address this gap in care, this project aims to develop a mobile tool designed to increase
      accessibility to information and practical approaches for addressing the complex needs of
      women in this 'fourth trimester'. This tool will specifically focus on underserved women who
      are at greatest risk of adverse postpartum outcomes.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Interviews were conducted with 24 pregnant and postpartum women. From this research and other activities, the investigators built a prototype program. Once the prototype was completed, the investigators conducted a clinical trial with 87 participants. The pre-test captured key outcome measures (resilience, stress, anxiety, depression, fear, knowledge, and variables related to COVID-19) and other descriptive variables. All participants who completed the pre-test were given access to the prototype mobile postpartum tool. Participants were asked to actively engage with the tool for 4 weeks, during which time they provided real-time user experience feedback. At the end of the 4-week period, the investigators conducted a post-test to measure change in outcomes.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change From Baseline Resilience at 4 Weeks
time frame: baseline, 4 weeks
description: Measured by the Connor-Davidson Resilience Scale, a 25-item scale covering 17 domains related to resiliency, used with a variety of populations, across a wide range of languages, racial/ethnic, and cultural groups. It has strong psychometric properties and validated short forms. Scoring of the scale is based on summing the total of all items, each of which is scored from 0-4. For the CD-RISC-25, the full range is from 0 to 100, with higher scores reflecting greater resilience.
measure: Change From Baseline Depressive Symptoms at 4 Weeks Using the Edinburgh Postnatal Depression Scale (EPDS)
time frame: baseline, 4 weeks
description: The Edinburgh Postnatal Depression Scale (EPDS) will be used to assess depressive symptoms. The 10-question Edinburgh Postnatal Depression Scale (EPDS) is a valuable and efficient way of identifying patients at risk for perinatal depression. Scores range from 0-30. Higher scores indicate more depressive symptoms. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.
measure: Change From Baseline Social Support at 4 Weeks Using the MOS Social Support Survey
time frame: baseline, 4 weeks
description: The MOS Social Support Survey will be used to assess overall social support and 4 subscales (Emotional/Informational Support; Tangible Support; Affectionate Support; Positive Social Interaction). The MOS Social Support Survey is a 19-item self-administered instrument. Items range from 1-5. The overall social support score is calculated as the mean response to all 19 items. Scores range from 19-95 with higher scores indicating more support.
measure: Change From Baseline Parent Anxiety at 4 Weeks
time frame: baseline, 4 weeks
description: The State-Trait Anxiety Inventory (STAI) is a measure of trait and state anxiety with 20 items for assessing trait anxiety and 20 for state anxiety. It has been validated for use with pregnant women. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-T and STAI-S subscales. Higher scores indicate greater anxiety.
measure: Change From COVID-19 and Mental Health Impacts at 4 Weeks
time frame: baseline, 4 weeks
description: The COVID-19 and Mental Health Impacts tool is a survey to help better understand how the novel coronavirus (COVID-19) pandemic is affecting people's emotional and mental health. A modified version of this instrument was used (removing Q1) to assess the impact of COVID-19 on study participants. All items are rated on a 5-point scale (from Strongly Disagree to Strongly Agree). The range of possible scores is 12-60, with higher scores indicating greater impact of COVID-19. The overall summary score is the sum of all items . While COVID-19 impact was not a formal endpoints, a descriptive analysis of this measure was conducted.
arm group label: Fourth Trimester Mobile Tool
arm group type: Other
description: Fourth Trimester Mobile Tool
intervention type: Behavioral
intervention name: Fourth Trimester Mobile Tool
description: A mobile web-based tool for underserved women in the fourth trimester. The mobile platform teaches self-efficacy, care management, and coping skills to help reduce major health risks and provide tools and resources to maintain mental health.
arm group label: Fourth Trimester Mobile Tool
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kristine Merz
role: Principal Investigator
affiliation: Orange Square Design, Inc.
last name: Lisa Marceau, MPH
role: Principal Investigator
affiliation: Carelon Research
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Carelon Research
investigator full name: Lisa Marceau
investigator title: Staff Vice President, Digital Research Solutions
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 