<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/NCT04486170</url>
  </required_header>
  <id_info>
    <org_study_id>IRB STUDY 00001865</org_study_id>
    <nct_id>NCT04486170</nct_id>
  </id_info>
  <brief_title>Assessment of Postpartum Education to Improve Compliance</brief_title>
  <official_title>Assessment of Patient Education as a Method of Optimizing Postpartum Care in Women With Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medstar Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medstar Health Research Institute</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>
      This is a prospective single centered randomized control study for postpartum patients&#xD;
      diagnosed with hypertension. Participants that meet inclusion criteria will be approached&#xD;
      while they are inpatient. After enrollment, all study subjects will receive an automated&#xD;
      blood pressure cuff and instructions on how to use it. Study participants in the intervention&#xD;
      group will be provided with educational material. The investigators hypothesize education in&#xD;
      postpartum women with hypertension can improve patient compliance with attendance at&#xD;
      postpartum care appointments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study group: postpartum women with a diagnosis of either chronic hypertension,&#xD;
      gestational hypertension, preeclampsia without severe features, preeclampsia with severe&#xD;
      features, chronic hypertension with superimposed preeclampsia with and without severe&#xD;
      features.&#xD;
&#xD;
      Recruitment: postpartum patients that meet the inclusion criteria will be approached&#xD;
      postpartum while they are still hospitalized. Once the study subjects are enrolled, they will&#xD;
      receive the same automatic blood pressure cuff and basic teaching on how to use it. All study&#xD;
      subjects will be asked to check their blood pressure once a day. The study subjects will be&#xD;
      advised that if systolic blood pressure is &gt; 160 or the diastolic blood pressure &gt;110, the&#xD;
      study subjects are asked to remain seated and repeat the BP measurement in 15 minutes, if&#xD;
      still elevated the study subject will be advised to call labor and delivery or proceed to&#xD;
      labor and delivery triage for further evaluation. All study subjects will be asked to follow&#xD;
      up for a blood pressure check 3-10 days after discharge home. All study subjects will be&#xD;
      weighed prior to discharge.&#xD;
&#xD;
      The study subject is then randomized to the control or intervention group. Both groups will&#xD;
      receive a survey. After the intervention group undergoes the educational component, this will&#xD;
      be the last time the study subjects meet with the investigator.&#xD;
&#xD;
      The data will be collected on an excel spreadsheet. Patient identifiers will be removed once&#xD;
      the study is completed. However, de-identified data may be used for future studies. The&#xD;
      database will be password protected on an excel spreadsheet and secured behind the Medstar&#xD;
      Washington Hospital Center firewall computers. Access to these databases is restricted to the&#xD;
      PI and the co-investigators. The data will be statistically analyzed in order to answer the&#xD;
      primary and secondary outcomes.&#xD;
&#xD;
      Power analysis: At Washington hospital center, the current attendance within 10 day&#xD;
      postpartum follow up appointments is 40% and at the 6 week appointment it is 70%. Based on&#xD;
      this data the investigator wants to evaluate if this postpartum education intervention can&#xD;
      cause a 100% difference in attendance within 10 days postpartum: 40% attendance which is the&#xD;
      current attendance rate (control) versus 80% (goal for the intervention group): enrollment of&#xD;
      46 patients is required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Actual">December 15, 2021</completion_date>
  <primary_completion_date type="Actual">June 25, 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance with postpartum care</measure>
    <time_frame>This outcome will be evaluated within 10 days of discharge</time_frame>
    <description>The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance with postpartum care</measure>
    <time_frame>This outcome will be evaluated within 6 weeks of delivery</time_frame>
    <description>The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of postpartum re-admission for hypertension related concerns</measure>
    <time_frame>This outcome will be evaluated within 6 weeks of delivery</time_frame>
    <description>The investigators will retrospectively review if the study participants are re-admitted for hypertension related concerns</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of postpartum labor and delivery triage visits</measure>
    <time_frame>This outcome will be evaluated within 6 weeks of delivery</time_frame>
    <description>The investigators will retrospectively review if the study participants are evaluated in the labor and delivery triage for hypertension related concerns</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of postpartum emergency department visits</measure>
    <time_frame>This outcome will be evaluated within 6 weeks of delivery</time_frame>
    <description>The investigators will retrospectively review if the study participants are evaluated in the emergency department for hypertension related concerns</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate weight (kg) change</measure>
    <time_frame>This outcome will be evaluated upon hospital admission</time_frame>
    <description>The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate weight (kg) change</measure>
    <time_frame>This outcome will be evaluated upon hospital discharge</time_frame>
    <description>The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate weight (kg) change</measure>
    <time_frame>This outcome will be evaluated within 6 week after delivery</time_frame>
    <description>The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of stroke</measure>
    <time_frame>This outcome will be evaluated within 6 weeks of delivery</time_frame>
    <description>The investigators will retrospectively review if the study participant suffered a stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of maternal death</measure>
    <time_frame>This outcome will be evaluated within 6 weeks of delivery</time_frame>
    <description>The investigators will retrospectively review maternal death during this study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant satisfaction with postpartum education using likert scale</measure>
    <time_frame>This outcome will be evaluated at time of recruitment, within 48hours</time_frame>
    <description>A likert scale survey will be administered by the investigator to the intervention and control group, the satisfaction score will be compared between both groups. The scale is reported as follows: 1 (Strongly disagree) 2 3 (neutral) 4 5 (strongly agree).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant satisfaction with postpartum education</measure>
    <time_frame>This outcome will be evaluated at time of recruitment, within 48hours</time_frame>
    <description>A survey will be administered by the investigator to the intervention and control group, the satisfaction score will be compared between both groups. The responses are either Yes or No. For most questions, answering yes would be a favorable response.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Hypertension in Pregnancy</condition>
  <condition>Postpartum Preeclampsia</condition>
  <arm_group>
    <arm_group_label>Control group: Current hospital education practices</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive standard of care postpartum educational materials provided by the nursing and resident physician staff. The will be asked to complete a brief questionnaire to determine if they would be interested in receiving education in a video formal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group: Standardized video and pamphlet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects enrolled in the invention group will be shown a 5 minute educational video on hypertension in the postpartum period. The patients will be shown the video on the ipad while they are in the comfort of their room. They will also be provided with a pamphlet with similar information that was discussed in the video. They will also be asked to complete a brief, anonymous survey to assess patient satisfaction with the video shown, no patient identifiers will be collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education provided via a video format</intervention_name>
    <description>The intervention group will be shown a 5 minute educational video on hypertension in the postpartum period. The patients will be shown the video on the ipad while they are in the comfort of their room and the investigator will step outside. At the conclusion of the video, the investigator will return into the patient room and provide a pamphlet with similar information that was discussed in the video for them to take home.</description>
    <arm_group_label>Intervention group: Standardized video and pamphlet</arm_group_label>
    <other_name>Education provided in a pamphlet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postpartum with diagnosis of Hypertension is defined as chronic hypertension,&#xD;
             gestational hypertension, preeclampsia without severe features, preeclampsia with&#xD;
             severe features, chronic hypertension with superimposed preeclampsia with and without&#xD;
             severe features.&#xD;
&#xD;
          -  At least 18 years or older&#xD;
&#xD;
          -  English speaking patient and also able to read in English&#xD;
&#xD;
          -  Plan to receive postpartum care at Washington Hospital Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who do not intend to follow up at Washington Hospital Center&#xD;
&#xD;
          -  Suffered from intrauterine fetal demise&#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>Sara Iqbal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medstar Washington Hospital Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>March 18, 2022</last_update_submitted>
  <last_update_submitted_qc>March 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Hypertension, Pregnancy-Induced</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04486170
org study id: IRB STUDY 00001865
nct id: NCT04486170
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective single centered randomized control study for postpartum patients
      diagnosed with hypertension. Participants that meet inclusion criteria will be approached
      while they are inpatient. After enrollment, all study subjects will receive an automated
      blood pressure cuff and instructions on how to use it. Study participants in the intervention
      group will be provided with educational material. The investigators hypothesize education in
      postpartum women with hypertension can improve patient compliance with attendance at
      postpartum care appointments.
The study group: postpartum women with a diagnosis of either chronic hypertension,
      gestational hypertension, preeclampsia without severe features, preeclampsia with severe
      features, chronic hypertension with superimposed preeclampsia with and without severe
      features.

      Recruitment: postpartum patients that meet the inclusion criteria will be approached
      postpartum while they are still hospitalized. Once the study subjects are enrolled, they will
      receive the same automatic blood pressure cuff and basic teaching on how to use it. All study
      subjects will be asked to check their blood pressure once a day. The study subjects will be
      advised that if systolic blood pressure is > 160 or the diastolic blood pressure >110, the
      study subjects are asked to remain seated and repeat the BP measurement in 15 minutes, if
      still elevated the study subject will be advised to call labor and delivery or proceed to
      labor and delivery triage for further evaluation. All study subjects will be asked to follow
      up for a blood pressure check 3-10 days after discharge home. All study subjects will be
      weighed prior to discharge.

      The study subject is then randomized to the control or intervention group. Both groups will
      receive a survey. After the intervention group undergoes the educational component, this will
      be the last time the study subjects meet with the investigator.

      The data will be collected on an excel spreadsheet. Patient identifiers will be removed once
      the study is completed. However, de-identified data may be used for future studies. The
      database will be password protected on an excel spreadsheet and secured behind the Medstar
      Washington Hospital Center firewall computers. Access to these databases is restricted to the
      PI and the co-investigators. The data will be statistically analyzed in order to answer the
      primary and secondary outcomes.

      Power analysis: At Washington hospital center, the current attendance within 10 day
      postpartum follow up appointments is 40% and at the 6 week appointment it is 70%. Based on
      this data the investigator wants to evaluate if this postpartum education intervention can
      cause a 100% difference in attendance within 10 days postpartum: 40% attendance which is the
      current attendance rate (control) versus 80% (goal for the intervention group): enrollment of
      46 patients is required.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Compliance with postpartum care
time frame: This outcome will be evaluated within 10 days of discharge
description: The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment
measure: Compliance with postpartum care
time frame: This outcome will be evaluated within 6 weeks of delivery
description: The investigators will perform a retrospective chart review to determine if the study participant attended the postpartum BP check appointment
measure: Incidence of postpartum re-admission for hypertension related concerns
time frame: This outcome will be evaluated within 6 weeks of delivery
description: The investigators will retrospectively review if the study participants are re-admitted for hypertension related concerns
measure: Incidence of postpartum labor and delivery triage visits
time frame: This outcome will be evaluated within 6 weeks of delivery
description: The investigators will retrospectively review if the study participants are evaluated in the labor and delivery triage for hypertension related concerns
measure: Incidence of postpartum emergency department visits
time frame: This outcome will be evaluated within 6 weeks of delivery
description: The investigators will retrospectively review if the study participants are evaluated in the emergency department for hypertension related concerns
measure: Evaluate weight (kg) change
time frame: This outcome will be evaluated upon hospital admission
description: The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
measure: Evaluate weight (kg) change
time frame: This outcome will be evaluated upon hospital discharge
description: The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
measure: Evaluate weight (kg) change
time frame: This outcome will be evaluated within 6 week after delivery
description: The investigators will retrospectively compare the participants weight upon delivery admission to weight upon discharge and within 6 weeks of delivery
measure: Incidence of stroke
time frame: This outcome will be evaluated within 6 weeks of delivery
description: The investigators will retrospectively review if the study participant suffered a stroke
measure: Incidence of maternal death
time frame: This outcome will be evaluated within 6 weeks of delivery
description: The investigators will retrospectively review maternal death during this study period
measure: Participant satisfaction with postpartum education using likert scale
time frame: This outcome will be evaluated at time of recruitment, within 48hours
description: A likert scale survey will be administered by the investigator to the intervention and control group, the satisfaction score will be compared between both groups. The scale is reported as follows: 1 (Strongly disagree) 2 3 (neutral) 4 5 (strongly agree).
measure: Participant satisfaction with postpartum education
time frame: This outcome will be evaluated at time of recruitment, within 48hours
description: A survey will be administered by the investigator to the intervention and control group, the satisfaction score will be compared between both groups. The responses are either Yes or No. For most questions, answering yes would be a favorable response.
arm group label: Control group: Current hospital education practices
arm group type: No Intervention
description: The control group will receive standard of care postpartum educational materials provided by the nursing and resident physician staff. The will be asked to complete a brief questionnaire to determine if they would be interested in receiving education in a video formal.
arm group label: Intervention group: Standardized video and pamphlet
arm group type: Experimental
description: The subjects enrolled in the invention group will be shown a 5 minute educational video on hypertension in the postpartum period. The patients will be shown the video on the ipad while they are in the comfort of their room. They will also be provided with a pamphlet with similar information that was discussed in the video. They will also be asked to complete a brief, anonymous survey to assess patient satisfaction with the video shown, no patient identifiers will be collected.
intervention type: Other
intervention name: Education provided via a video format
description: The intervention group will be shown a 5 minute educational video on hypertension in the postpartum period. The patients will be shown the video on the ipad while they are in the comfort of their room and the investigator will step outside. At the conclusion of the video, the investigator will return into the patient room and provide a pamphlet with similar information that was discussed in the video for them to take home.
arm group label: Intervention group: Standardized video and pamphlet
other name: Education provided in a pamphlet
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sara Iqbal, MD
role: Principal Investigator
affiliation: Medstar Washington Hospital Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pre-Eclampsia
mesh term: Hypertension, Pregnancy-Induced
mesh term: Hypertension
sharing ipd: No