<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/NCT01688427</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00051481</org_study_id>
    <secondary_id>1R01HD071771-01</secondary_id>
    <nct_id>NCT01688427</nct_id>
  </id_info>
  <brief_title>Perinatal Nurse Home Visiting Enhanced With mHealth Technology</brief_title>
  <official_title>Perinatal Nurse Home Visiting Enhanced With mHealth Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</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 University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is being done to test whether mobile technology will reduce possible&#xD;
      communication barriers between women and their home visitor; to improve assessing for health&#xD;
      problems that could affect their pregnancy; to help in the delivery of information and&#xD;
      actions to improve the health of the woman and their child.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study addresses PA-11-104 calling for Reducing Health Disparities among Minority and&#xD;
      Underserved Children. The Institute of Medicine, World Health Organization and Centers for&#xD;
      Disease Control and Prevention recognize that prenatal home visitation, which improves the&#xD;
      well-being of mother and children, presents an opportunity to provide early intervention to&#xD;
      reduce intimate partner violence (IPV) and the impact the exposure has on the children. Major&#xD;
      challenges for nurses and other home visitors (HV) are to accurately identify abused women&#xD;
      and facilitate their accessing resources needed to change their situation. HVs often find it&#xD;
      difficult to assess and intervene for IPV in the intimacy of home settings. The use of&#xD;
      mHealth technology may increase the sensitivity of screening instruments and reduce&#xD;
      communication barriers between HVs and clients regarding IPV, as well as enhance&#xD;
      implementation of IPV interventions and allow for a more standard delivery of an&#xD;
      intervention. Building on the successful trial testing the DOVE IPV intervention in prenatal&#xD;
      home visiting programs (NR009093), the investigators propose to test mHealth technology using&#xD;
      an open-source application, eMOCHA, to improve assessment of IPV and to deliver the DOVE&#xD;
      intervention. The proposed eMOCHA DOVE study will first (Specific Aim/Phase 1) compare&#xD;
      sensitivity and specificity of two different approaches for IPV assessment; paper and pencil&#xD;
      versus the eMOCHA mHealth technology. Phase 2 (Aim 2) will compare effectiveness of the DOVE&#xD;
      intervention delivered in standard form (paper brochure) versus mHealth eMOCHA DOVE&#xD;
      application. In Phase 1 women enrolled in a perinatal home visiting program and consenting to&#xD;
      the study, will be randomized to one of the two assessment groups and assessed for IPV at&#xD;
      enrollment, birth and 2 months post birth. Women who are IPV positive (IPV+) at any of the&#xD;
      assessment times will be re-randomized to receive the DOVE intervention by one of the two&#xD;
      approaches. 1600 Medicaid eligible pregnant women in a perinatal home visiting program (800&#xD;
      from urban Baltimore and 800 from rural Virginia) will be recruited for Phase I and 400 IPV+&#xD;
      women (200 from each site) for Phase II. Women participating in Phase 2 will receive 6 home&#xD;
      visit interventions over 6 months. Maternal outcomes related to IPV and mental health and&#xD;
      selected infant outcomes will be collected at enrollment, 3, 6, 12, and 18 months after entry&#xD;
      into Phase 2. Specific Aim 1 will use logistic and linear regression models to examine the&#xD;
      proportion of women experiencing IPV through mHealth technology versus paper and pencil on&#xD;
      the same validated assessments. Specific Aim 2 (comparing effectiveness of two intervention&#xD;
      administrations) will be assessed with logistic and linear regression models for categorical&#xD;
      (proportion abused and premature infants) and continuous outcome variables (e.g. depression,&#xD;
      frequency and severity of physical, psychological, sexual IPV, use of community resources)&#xD;
      respectively. Study findings will assist nurse home visitation programs to use best&#xD;
      approaches for routine assessment of IPV and implement empowerment interventions to reduce&#xD;
      IPV and improve maternal infant health outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2016</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in IPV assessments</measure>
    <time_frame>Screening and at 2 months post-birth.</time_frame>
    <description>Instances of intimate partner violence (IPV).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in use of safety behaviors</measure>
    <time_frame>Baseline and end of study (approximately 18 months post-birth)</time_frame>
    <description>Record the number of pregnant/parenting women using safety behaviors (including mental health and other community resources).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of safety behaviors</measure>
    <time_frame>Baseline and end of study (approximately 18 months post-birth)</time_frame>
    <description>Record the aggregate number of services (including mental health and other community resources).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">433</enrollment>
  <condition>Domestic Violence</condition>
  <condition>Intimate Partner Violence</condition>
  <arm_group>
    <arm_group_label>Standard IPV Assessment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test the effectiveness of the eMOCHA DOVE application using mHealth technology for routine assessment of IPV vs. Pencil and paper.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard DOVE intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The standard DOVE intervention has already been developed and tested (NR009093). The standard DOVE intervention is a brochure based 10 minute intervention that the home visitor reviews with the women. It consists of information about IPV, its effects on pregnancy and infant health, community resources and a plan for individual safety options. For the eMOCHA DOVE intervention, the DOVE 10 minute brochure intervention will be converted from the paper format to a visually colorful interactive presentation loaded into the home visitor device using the eMOCHA application. The format will be completely activated and implemented by the women. She uses small ear buds and a touch screen, so how she responds and interacts with the media enhanced eMOCHA DOVE intervention is private.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard IPV Assessment</intervention_name>
    <description>Test the effectiveness of the eMOCHA DOVE application using mHealth technology for routine assessment of IPV vs. Pencil and paper at enrollment, delivery, and 2 months post birth.</description>
    <arm_group_label>Standard DOVE intervention</arm_group_label>
    <arm_group_label>Standard IPV Assessment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard DOVE Intervention</intervention_name>
    <description>Intervention will be administered via eMOCHA tablet vs. home visitor over 6 sessions in 6 months.</description>
    <arm_group_label>Standard DOVE intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women in Baltimore, Virginia, and Missouri if needed.&#xD;
&#xD;
          -  Speak English or Spanish&#xD;
&#xD;
          -  Eligible for home visitation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who begin participation in a perinatal home visiting program after the baby is&#xD;
             born.&#xD;
&#xD;
          -  Women who do not speak English or Spanish.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Phyllis W Sharps, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University, School of Nursing</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linda Bullock, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University, School of Nursing</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>March 2019</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01688427
org study id: NA_00051481
secondary id: 1R01HD071771-01
nct id: NCT01688427
lead sponsor: 
collaborator: 
has dmc: Yes
This research is being done to test whether mobile technology will reduce possible
      communication barriers between women and their home visitor; to improve assessing for health
      problems that could affect their pregnancy; to help in the delivery of information and
      actions to improve the health of the woman and their child.
This study addresses PA-11-104 calling for Reducing Health Disparities among Minority and
      Underserved Children. The Institute of Medicine, World Health Organization and Centers for
      Disease Control and Prevention recognize that prenatal home visitation, which improves the
      well-being of mother and children, presents an opportunity to provide early intervention to
      reduce intimate partner violence (IPV) and the impact the exposure has on the children. Major
      challenges for nurses and other home visitors (HV) are to accurately identify abused women
      and facilitate their accessing resources needed to change their situation. HVs often find it
      difficult to assess and intervene for IPV in the intimacy of home settings. The use of
      mHealth technology may increase the sensitivity of screening instruments and reduce
      communication barriers between HVs and clients regarding IPV, as well as enhance
      implementation of IPV interventions and allow for a more standard delivery of an
      intervention. Building on the successful trial testing the DOVE IPV intervention in prenatal
      home visiting programs (NR009093), the investigators propose to test mHealth technology using
      an open-source application, eMOCHA, to improve assessment of IPV and to deliver the DOVE
      intervention. The proposed eMOCHA DOVE study will first (Specific Aim/Phase 1) compare
      sensitivity and specificity of two different approaches for IPV assessment; paper and pencil
      versus the eMOCHA mHealth technology. Phase 2 (Aim 2) will compare effectiveness of the DOVE
      intervention delivered in standard form (paper brochure) versus mHealth eMOCHA DOVE
      application. In Phase 1 women enrolled in a perinatal home visiting program and consenting to
      the study, will be randomized to one of the two assessment groups and assessed for IPV at
      enrollment, birth and 2 months post birth. Women who are IPV positive (IPV+) at any of the
      assessment times will be re-randomized to receive the DOVE intervention by one of the two
      approaches. 1600 Medicaid eligible pregnant women in a perinatal home visiting program (800
      from urban Baltimore and 800 from rural Virginia) will be recruited for Phase I and 400 IPV+
      women (200 from each site) for Phase II. Women participating in Phase 2 will receive 6 home
      visit interventions over 6 months. Maternal outcomes related to IPV and mental health and
      selected infant outcomes will be collected at enrollment, 3, 6, 12, and 18 months after entry
      into Phase 2. Specific Aim 1 will use logistic and linear regression models to examine the
      proportion of women experiencing IPV through mHealth technology versus paper and pencil on
      the same validated assessments. Specific Aim 2 (comparing effectiveness of two intervention
      administrations) will be assessed with logistic and linear regression models for categorical
      (proportion abused and premature infants) and continuous outcome variables (e.g. depression,
      frequency and severity of physical, psychological, sexual IPV, use of community resources)
      respectively. Study findings will assist nurse home visitation programs to use best
      approaches for routine assessment of IPV and implement empowerment interventions to reduce
      IPV and improve maternal infant health outcomes.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in IPV assessments
time frame: Screening and at 2 months post-birth.
description: Instances of intimate partner violence (IPV).
measure: Change in use of safety behaviors
time frame: Baseline and end of study (approximately 18 months post-birth)
description: Record the number of pregnant/parenting women using safety behaviors (including mental health and other community resources).
measure: Change in number of safety behaviors
time frame: Baseline and end of study (approximately 18 months post-birth)
description: Record the aggregate number of services (including mental health and other community resources).
arm group label: Standard IPV Assessment
arm group type: Experimental
description: Test the effectiveness of the eMOCHA DOVE application using mHealth technology for routine assessment of IPV vs. Pencil and paper.
arm group label: Standard DOVE intervention
arm group type: Experimental
description: The standard DOVE intervention has already been developed and tested (NR009093). The standard DOVE intervention is a brochure based 10 minute intervention that the home visitor reviews with the women. It consists of information about IPV, its effects on pregnancy and infant health, community resources and a plan for individual safety options. For the eMOCHA DOVE intervention, the DOVE 10 minute brochure intervention will be converted from the paper format to a visually colorful interactive presentation loaded into the home visitor device using the eMOCHA application. The format will be completely activated and implemented by the women. She uses small ear buds and a touch screen, so how she responds and interacts with the media enhanced eMOCHA DOVE intervention is private.
intervention type: Behavioral
intervention name: Standard IPV Assessment
description: Test the effectiveness of the eMOCHA DOVE application using mHealth technology for routine assessment of IPV vs. Pencil and paper at enrollment, delivery, and 2 months post birth.
arm group label: Standard DOVE intervention
arm group label: Standard IPV Assessment
intervention type: Behavioral
intervention name: Standard DOVE Intervention
description: Intervention will be administered via eMOCHA tablet vs. home visitor over 6 sessions in 6 months.
arm group label: Standard DOVE intervention
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Phyllis W Sharps, PhD
role: Principal Investigator
affiliation: Johns Hopkins University, School of Nursing
last name: Linda Bullock, PhD, RN
role: Principal Investigator
affiliation: University of Virginia
facility: 
country: United States
responsible party type: Sponsor