xml: <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/NCT05974865</url>
    </required_header>
    <id_info>
      <org_study_id>HD050437</org_study_id>
      <secondary_id>R01HD050437</secondary_id>
      <nct_id>NCT05974865</nct_id>
    </id_info>
    <brief_title>Amelioration of Literacy Deficits in Prenatal Care</brief_title>
    <official_title>Amelioration of Literacy Deficits in Prenatal Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johns Hopkins Bloomberg School of Public Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Johns Hopkins Bloomberg School of Public Health</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the study was to develop and evaluate a skill-based, computer intervention&#xD;
        designed to facilitate effective prenatal visit communication for women with restricted&#xD;
        literacy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary aim of the study is to develop and evaluate a skills-based, interactive computer&#xD;
        intervention designed to enhance the communication skills of pregnant women with restricted&#xD;
        literacy. To this end, a randomized trial compared a skill-based computer intervention to a&#xD;
        facilitated review of pertinent print-based educational material on communication processes&#xD;
        and its consequences. Intervention impact was evaluated through medical visit recordings and&#xD;
        post-visit assessments by patients and clinicians. We hypothesized that women assigned to the&#xD;
        skills-based, computer intervention would demonstrate greater use of targeted skills, be more&#xD;
        actively engaged in the communication process, and experience more patient-centered visits&#xD;
        than women assigned to the print-based intervention. We also hypothesized that computer use&#xD;
        would result in greater visit satisfaction and closer patient and clinician alignment in&#xD;
        their assessment of the patient's physical and emotional health status..&#xD;
  &#xD;
        Study Design included 84 women seeing 19 obstetrical clinicians were randomized to use an&#xD;
        interactive, skill-based, computer program or to a personalized review of a prenatal guide.&#xD;
        Prenatal visits were recorded and coded using the Roter Interaction Analysis System (RIAS).&#xD;
        Post-visit satisfaction and perceptions of physical and emotional health were reported.&#xD;
        Analysis adjusted for the nesting of patients within physicians, gestation, literacy and&#xD;
        visit length.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date>September 2006</start_date>
    <completion_date type="Actual">June 2011</completion_date>
    <primary_completion_date type="Actual">June 2011</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>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>patient-centered communication</measure>
      <time_frame>Baseline</time_frame>
      <description>Audio recordings of the prenatal visits are coded using the Roter Interaction Analysis System (RIAS). The communication outcome measure is derived from this coding.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>depression as assessed by the Edinburgh Depression Scale</measure>
      <time_frame>post medical visit up to 8 months</time_frame>
      <description>The correlation between patient score on the The Edinburgh Depression Scale and the clinician's rating of signs of emotional state. The Edinburgh has 10 items items on a 4 point scale with score range 10-40. Higher scores indicating more symptoms of depression. Clinician completed a novel post visit assessment of the participant's emotional state asking to indicate signs of anxiety and depression observed during the recorded visit. 1 (no signs), 2 (some symptoms, but no illness), ), 3 (mild case), 4 (moderate case), 5 (severe case). Higher ratings indicated more significant anxiety and depression.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>patient satisfaction as assessed by a questionnaire developed by the study team</measure>
      <time_frame>post medical visit up to 8 months</time_frame>
      <description>Patient satisfaction with medical visit as assessed by a questionnaire developed by the study team. The measure consisted of 8 items on a 5-point scale ranging from poor (1) to excellent (5). Scale scores range from 8- 40.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">355</enrollment>
    <condition>Prenatal Care</condition>
    <condition>Health Literacy</condition>
    <condition>Numeracy</condition>
    <arm_group>
      <arm_group_label>Healthy Babies and Health Moms</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy Babies and Healthy Moms was designed as a 20-minute communication skills-based computer program based on key social learning principles designed to empower women to more actively and productively use targetted skills to improve the medical dialogue of their prenatal visits.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Baby Basics Prenatal Guide</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The Baby Basics Prenatal Guide, published by the What to Expect Foundation, was used in a face-to-face educational session with a study research assistant during which pregnancy related information was personalized by reviewing relevant sections of the Baby Basics prenatal guide.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Healthy Babies and Healthy Moms</intervention_name>
      <arm_group_label>Healthy Babies and Health Moms</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Baby Basics Prenatal Guide</intervention_name>
      <arm_group_label>Baby Basics Prenatal Guide</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women attending study prenatal clinics with consenting clinicians. English&#xD;
               speaking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Debra Roter, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Johns Hopkins Hospital</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21205</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 22, 2014</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>patient-physician communication</keyword>
    <keyword>patient activation intervention</keyword>
    <keyword>RIAS</keyword>
    <keyword>health literacy</keyword>
    <keyword>spoken literacy</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974865
  org study id: HD050437
  secondary id: R01HD050437
  nct id: NCT05974865
  lead sponsor: 
  collaborator: 
  has dmc: No
  The purpose of the study was to develop and evaluate a skill-based, computer intervention
        designed to facilitate effective prenatal visit communication for women with restricted
        literacy.
  The primary aim of the study is to develop and evaluate a skills-based, interactive computer
        intervention designed to enhance the communication skills of pregnant women with restricted
        literacy. To this end, a randomized trial compared a skill-based computer intervention to a
        facilitated review of pertinent print-based educational material on communication processes
        and its consequences. Intervention impact was evaluated through medical visit recordings and
        post-visit assessments by patients and clinicians. We hypothesized that women assigned to the
        skills-based, computer intervention would demonstrate greater use of targeted skills, be more
        actively engaged in the communication process, and experience more patient-centered visits
        than women assigned to the print-based intervention. We also hypothesized that computer use
        would result in greater visit satisfaction and closer patient and clinician alignment in
        their assessment of the patient's physical and emotional health status..
  
        Study Design included 84 women seeing 19 obstetrical clinicians were randomized to use an
        interactive, skill-based, computer program or to a personalized review of a prenatal guide.
        Prenatal visits were recorded and coded using the Roter Interaction Analysis System (RIAS).
        Post-visit satisfaction and perceptions of physical and emotional health were reported.
        Analysis adjusted for the nesting of patients within physicians, gestation, literacy and
        visit length.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: patient-centered communication
  time frame: Baseline
  description: Audio recordings of the prenatal visits are coded using the Roter Interaction Analysis System (RIAS). The communication outcome measure is derived from this coding.
  measure: depression as assessed by the Edinburgh Depression Scale
  time frame: post medical visit up to 8 months
  description: The correlation between patient score on the The Edinburgh Depression Scale and the clinician's rating of signs of emotional state. The Edinburgh has 10 items items on a 4 point scale with score range 10-40. Higher scores indicating more symptoms of depression. Clinician completed a novel post visit assessment of the participant's emotional state asking to indicate signs of anxiety and depression observed during the recorded visit. 1 (no signs), 2 (some symptoms, but no illness), ), 3 (mild case), 4 (moderate case), 5 (severe case). Higher ratings indicated more significant anxiety and depression.
  measure: patient satisfaction as assessed by a questionnaire developed by the study team
  time frame: post medical visit up to 8 months
  description: Patient satisfaction with medical visit as assessed by a questionnaire developed by the study team. The measure consisted of 8 items on a 5-point scale ranging from poor (1) to excellent (5). Scale scores range from 8- 40.
  arm group label: Healthy Babies and Health Moms
  arm group type: Experimental
  description: Healthy Babies and Healthy Moms was designed as a 20-minute communication skills-based computer program based on key social learning principles designed to empower women to more actively and productively use targetted skills to improve the medical dialogue of their prenatal visits.
  arm group label: Baby Basics Prenatal Guide
  arm group type: Active Comparator
  description: The Baby Basics Prenatal Guide, published by the What to Expect Foundation, was used in a face-to-face educational session with a study research assistant during which pregnancy related information was personalized by reviewing relevant sections of the Baby Basics prenatal guide.
  intervention type: Behavioral
  intervention name: Healthy Babies and Healthy Moms
  arm group label: Healthy Babies and Health Moms
  intervention type: Behavioral
  intervention name: Baby Basics Prenatal Guide
  arm group label: Baby Basics Prenatal Guide
  criteria: 
  gender: Female
  minimum age: 16 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Debra Roter, PhD
  role: Principal Investigator
  affiliation: Johns Hopkins Bloomberg School of Public Health
  facility: 
  country: United States
  responsible party type: Sponsor