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/NCT05995106</url>
    </required_header>
    <id_info>
      <org_study_id>B-2308-844-302</org_study_id>
      <nct_id>NCT05995106</nct_id>
    </id_info>
    <brief_title>mHealth for Hypertensive Disorder of Pregnancy</brief_title>
    <official_title>Prospective Validation of Usefulness in the Hypertensive Disorder of Pregnancy With Cardiovascular Disease Management Solution Based on Interconnection to Hospital Examination</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seoul National University Hospital</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>
        Objectives: We have developed a cardiovascular disease management application named Heart4U,&#xD;
        with the capability of integrating with the Electronic Medical Records (EMR) system within&#xD;
        the hospital.&#xD;
  &#xD;
        The main goal of this study is to evaluate the clinical effectiveness of a treatment approach&#xD;
        that entails self-management of risk factors through a mobile application among pregnant&#xD;
        individuals diagnosed with hypertensive cardiovascular conditions.&#xD;
  &#xD;
        Methods: Patients assigned to the app group receive assistance from the research team to&#xD;
        install the Heart4U application and familiarize themselves with its usage. Both the app group&#xD;
        and the usual care group continue to receive active treatment as previously administered&#xD;
        (guideline-based prenatal care). Follow-up observations occur at each obstetric examination&#xD;
        prior to delivery and are conducted again at the first month postpartum. The primary endpoint&#xD;
        of observation pertains to the difference in systolic blood pressure between the enrollment&#xD;
        and study completion time points.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Inclusion Criteria:&#xD;
  &#xD;
          -  Diagnosis: 1 or 2&#xD;
  &#xD;
               1. Pregnant women diagnosed with hypertensive disorders of pregnancy at or beyond 12&#xD;
                  weeks of gestation:&#xD;
  &#xD;
                    -  Chronic hypertension: Diagnosed with hypertension within 20 weeks of gestation&#xD;
                       (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently on&#xD;
                       antihypertensive medication.&#xD;
  &#xD;
                    -  Gestational hypertension: Newly diagnosed with hypertension after 20 weeks of&#xD;
                       gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently&#xD;
                       on antihypertensive medication.&#xD;
  &#xD;
                    -  Preeclampsia: Newly diagnosed with hypertension after 20 weeks of gestation&#xD;
                       (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently on&#xD;
                       antihypertensive medication, and presents with proteinuria (300 mg/24 hours or&#xD;
                       urine protein-to-creatinine ratio ≥0.3), thrombocytopenia (less than 100,000&#xD;
                       platelets per microliter), abnormal renal function (creatinine exceeding 1.1&#xD;
                       or doubling of baseline), elevated liver enzymes (twice normal levels),&#xD;
                       neurological symptoms (headache, visual disturbances, seizures, etc.), and/or&#xD;
                       pulmonary edema.&#xD;
  &#xD;
                    -  Superimposed preeclampsia: Diagnosed with hypertension within 20 weeks of&#xD;
                       gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently&#xD;
                       on antihypertensive medication, and experiences symptoms or signs related to&#xD;
                       superimposed preeclampsia.&#xD;
  &#xD;
               2. Pregnant women at elevated risk for hypertensive disorders of pregnancy:&#xD;
  &#xD;
                  Multifetal gestation, obesity, uncontrolled gestational or pre-existing diabetes,&#xD;
                  history of hypertensive disorder of pregnancy leading to preterm birth, presence of&#xD;
                  borderline blood pressure readings during antepartum care (elevated office/clinic&#xD;
                  blood pressure ≥130/80 mm Hg) following a previous diagnosis of&#xD;
                  hypertension-related disorder in a prior pregnancy.&#xD;
  &#xD;
          -  Adult individuals aged 18 years and above who possess a smartphone and are capable of&#xD;
             independently utilizing the application, among pregnant women.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2027</completion_date>
    <primary_completion_date type="Anticipated">August 2026</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>delta SBP</measure>
      <time_frame>between at the time of enrollment and one month postpartum</time_frame>
      <description>Systolic Blood pressure (SBP) difference</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood pressure (systolic, diastolic, mean) trajectory</measure>
      <time_frame>between at the time of enrollment and one month postpartum</time_frame>
      <description>BP measured at each visit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>obstetric outcomes</measure>
      <time_frame>between at the time of enrollment and one month postpartum</time_frame>
      <description>(The use of antihypertensive medication, progression to eclampsia or preeclampsia, pulmonary edema, fetal growth restriction, oligohydramnios, premature placental abruption, preterm birth (delivery between 20 and less than 37 weeks of gestation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body mass index (kg/m2) trajectory</measure>
      <time_frame>between at the time of enrollment and one month postpartum</time_frame>
      <description>BP measured at each visit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>trajectory of the recorded step counts</measure>
      <time_frame>between at the time of enrollment and one month postpartum</time_frame>
      <description>on a pedometer application within a mobile phone.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression evaluation questionnaire</measure>
      <time_frame>at the time of enrollment and one month postpartum</time_frame>
      <description>Patient health questionnaires-9, Beck Depression Inventory</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drug compliance</measure>
      <time_frame>at the time of enrollment and one month postpartum</time_frame>
      <description>MMAS scale</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">580</enrollment>
    <condition>Hypertensive Disorder of Pregnancy</condition>
    <condition>Preeclampsia</condition>
    <arm_group>
      <arm_group_label>App Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients assigned to the app group receive assistance from the research team to install the Heart4U application and familiarize themselves with its usage.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The app (n=290) and usual care groups (n-290) continue to receive active treatment as previously administered (guideline-based prenatal care).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Heart4U</intervention_name>
      <description>Mobile app.</description>
      <arm_group_label>App Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis: 1 or 2&#xD;
  &#xD;
                 1. Pregnant women diagnosed with hypertensive disorders of pregnancy at or beyond 12&#xD;
                    weeks of gestation:&#xD;
  &#xD;
                      -  Chronic hypertension: Diagnosed with hypertension within 20 weeks of&#xD;
                         gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently&#xD;
                         on antihypertensive medication.&#xD;
  &#xD;
                      -  Gestational hypertension: Newly diagnosed with hypertension after 20 weeks&#xD;
                         of gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or&#xD;
                         currently on antihypertensive medication.&#xD;
  &#xD;
                      -  Preeclampsia: Newly diagnosed with hypertension after 20 weeks of gestation&#xD;
                         (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently on&#xD;
                         antihypertensive medication, and presents with proteinuria (300 mg/24 hours&#xD;
                         or urine protein-to-creatinine ratio ≥0.3), thrombocytopenia (less than&#xD;
                         100,000 platelets per microliter), abnormal renal function (creatinine&#xD;
                         exceeding 1.1 or doubling of baseline), elevated liver enzymes (twice normal&#xD;
                         levels), neurological symptoms (headache, visual disturbances, seizures,&#xD;
                         etc.), and/or pulmonary edema.&#xD;
  &#xD;
                      -  Superimposed preeclampsia: Diagnosed with hypertension within 20 weeks of&#xD;
                         gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently&#xD;
                         on antihypertensive medication and experiences symptoms or signs related to&#xD;
                         superimposed preeclampsia.&#xD;
  &#xD;
                 2. Pregnant women at elevated risk for hypertensive disorders of pregnancy:&#xD;
  &#xD;
                    Multifetal gestation, obesity, uncontrolled gestational or pre-existing diabetes,&#xD;
                    history of hypertensive disorder of pregnancy leading to preterm birth, presence&#xD;
                    of borderline blood pressure readings during antepartum care (elevated&#xD;
                    office/clinic blood pressure ≥130/80 mm Hg) following a previous diagnosis of&#xD;
                    hypertension-related disorder in a prior pregnancy.&#xD;
  &#xD;
                    , and&#xD;
  &#xD;
            -  Adult individuals aged 18 years and above who possess a smartphone and are capable of&#xD;
               independently utilizing the application among pregnant women.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with evidence of delusions, confusion, or other cognitive disorders.&#xD;
  &#xD;
            -  Patients deemed difficult to conduct this study on by the researchers due to various&#xD;
               reasons.&#xD;
  &#xD;
            -  Cases where device familiarity is significantly low, making data collection&#xD;
               challenging.&#xD;
  &#xD;
            -  Pregnant patients requiring immediate electronic fetal monitoring or maternal&#xD;
               monitoring due to imminent delivery.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jung-Won Suh, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Seoul National University Bundang Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jung-Won Suh, MD</last_name>
      <phone>+821076615931</phone>
      <email>suhjw1@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hye-Jin Kim, RN</last_name>
      <phone>+82317877016</phone>
      <email>kimhj258@gmail.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Kang SH, Baek H, Cho J, Kim S, Hwang H, Lee W, Park JJ, Yoon YE, Yoon CH, Cho YS, Youn TJ, Cho GY, Chae IH, Choi DJ, Yoo S, Suh JW. Management of cardiovascular disease using an mHealth tool: a randomized clinical trial. NPJ Digit Med. 2021 Dec 3;4(1):165. doi: 10.1038/s41746-021-00535-z.</citation>
      <PMID>34862449</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
      <investigator_full_name>Jung-Won Suh</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Toxemia</mesh_term>
      <mesh_term>Pre-Eclampsia</mesh_term>
      <mesh_term>Pregnancy Complications</mesh_term>
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <!-- 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/NCT05995106
  org study id: B-2308-844-302
  nct id: NCT05995106
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objectives: We have developed a cardiovascular disease management application named Heart4U,
        with the capability of integrating with the Electronic Medical Records (EMR) system within
        the hospital.
  
        The main goal of this study is to evaluate the clinical effectiveness of a treatment approach
        that entails self-management of risk factors through a mobile application among pregnant
        individuals diagnosed with hypertensive cardiovascular conditions.
  
        Methods: Patients assigned to the app group receive assistance from the research team to
        install the Heart4U application and familiarize themselves with its usage. Both the app group
        and the usual care group continue to receive active treatment as previously administered
        (guideline-based prenatal care). Follow-up observations occur at each obstetric examination
        prior to delivery and are conducted again at the first month postpartum. The primary endpoint
        of observation pertains to the difference in systolic blood pressure between the enrollment
        and study completion time points.
  Inclusion Criteria:
  
          -  Diagnosis: 1 or 2
  
               1. Pregnant women diagnosed with hypertensive disorders of pregnancy at or beyond 12
                  weeks of gestation:
  
                    -  Chronic hypertension: Diagnosed with hypertension within 20 weeks of gestation
                       (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently on
                       antihypertensive medication.
  
                    -  Gestational hypertension: Newly diagnosed with hypertension after 20 weeks of
                       gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently
                       on antihypertensive medication.
  
                    -  Preeclampsia: Newly diagnosed with hypertension after 20 weeks of gestation
                       (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently on
                       antihypertensive medication, and presents with proteinuria (300 mg/24 hours or
                       urine protein-to-creatinine ratio ≥0.3), thrombocytopenia (less than 100,000
                       platelets per microliter), abnormal renal function (creatinine exceeding 1.1
                       or doubling of baseline), elevated liver enzymes (twice normal levels),
                       neurological symptoms (headache, visual disturbances, seizures, etc.), and/or
                       pulmonary edema.
  
                    -  Superimposed preeclampsia: Diagnosed with hypertension within 20 weeks of
                       gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently
                       on antihypertensive medication, and experiences symptoms or signs related to
                       superimposed preeclampsia.
  
               2. Pregnant women at elevated risk for hypertensive disorders of pregnancy:
  
                  Multifetal gestation, obesity, uncontrolled gestational or pre-existing diabetes,
                  history of hypertensive disorder of pregnancy leading to preterm birth, presence of
                  borderline blood pressure readings during antepartum care (elevated office/clinic
                  blood pressure ≥130/80 mm Hg) following a previous diagnosis of
                  hypertension-related disorder in a prior pregnancy.
  
          -  Adult individuals aged 18 years and above who possess a smartphone and are capable of
             independently utilizing the application, among pregnant women.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: delta SBP
  time frame: between at the time of enrollment and one month postpartum
  description: Systolic Blood pressure (SBP) difference
  measure: Blood pressure (systolic, diastolic, mean) trajectory
  time frame: between at the time of enrollment and one month postpartum
  description: BP measured at each visit
  measure: obstetric outcomes
  time frame: between at the time of enrollment and one month postpartum
  description: (The use of antihypertensive medication, progression to eclampsia or preeclampsia, pulmonary edema, fetal growth restriction, oligohydramnios, premature placental abruption, preterm birth (delivery between 20 and less than 37 weeks of gestation)
  measure: Body mass index (kg/m2) trajectory
  time frame: between at the time of enrollment and one month postpartum
  description: BP measured at each visit
  measure: trajectory of the recorded step counts
  time frame: between at the time of enrollment and one month postpartum
  description: on a pedometer application within a mobile phone.
  measure: Depression evaluation questionnaire
  time frame: at the time of enrollment and one month postpartum
  description: Patient health questionnaires-9, Beck Depression Inventory
  measure: Drug compliance
  time frame: at the time of enrollment and one month postpartum
  description: MMAS scale
  arm group label: App Group
  arm group type: Experimental
  description: Patients assigned to the app group receive assistance from the research team to install the Heart4U application and familiarize themselves with its usage.
  arm group label: Usual Care Group
  arm group type: No Intervention
  description: The app (n=290) and usual care groups (n-290) continue to receive active treatment as previously administered (guideline-based prenatal care).
  intervention type: Other
  intervention name: Heart4U
  description: Mobile app.
  arm group label: App Group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jung-Won Suh, MD
  role: Principal Investigator
  affiliation: Seoul National University Bundang Hospital
  last name: Jung-Won Suh, MD
  phone: +821076615931
  email: suhjw1@gmail.com
  last name: Hye-Jin Kim, RN
  phone: +82317877016
  email: kimhj258@gmail.com
  citation: Kang SH, Baek H, Cho J, Kim S, Hwang H, Lee W, Park JJ, Yoon YE, Yoon CH, Cho YS, Youn TJ, Cho GY, Chae IH, Choi DJ, Yoo S, Suh JW. Management of cardiovascular disease using an mHealth tool: a randomized clinical trial. NPJ Digit Med. 2021 Dec 3;4(1):165. doi: 10.1038/s41746-021-00535-z.
  PMID: 34862449
  responsible party type: Principal Investigator
  investigator affiliation: Seoul National University Hospital
  investigator full name: Jung-Won Suh
  investigator title: Professor
  mesh term: Toxemia
  mesh term: Pre-Eclampsia
  mesh term: Pregnancy Complications
  mesh term: Hypertension