<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/NCT03305003</url>
  </required_header>
  <id_info>
    <org_study_id>FAM 81-3193</org_study_id>
    <nct_id>NCT03305003</nct_id>
  </id_info>
  <brief_title>Evaluating How a Mobile App Can Improve Prenatal Care</brief_title>
  <official_title>Evaluating How a Mobile App Can Improve Prenatal Care: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry M. Jackson Foundation for the Advancement of Military Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry M. Jackson Foundation for the Advancement of Military Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Throughout the Military Health System, pregnant mothers are issued a spiral-bound guide that&#xD;
      provides week by week information about pregnancy, preventive health messages, appointment&#xD;
      information, and space to record their experiences throughout their pregnancy. When used&#xD;
      accordingly, the evidence-based guide is an effective tool for motivating patients to&#xD;
      participate in their own healthcare and achieve care goals. However, the spiral-bound paper&#xD;
      modality results in patients forgetting the book for appointments or losing it. By testing a&#xD;
      mobile application (app) from the current publication, the MHS leverages the efforts which&#xD;
      created the guide while increasing patient and provider use.&#xD;
&#xD;
      The multisite testing (randomized controlled trial) of a mobile application developed from&#xD;
      the current spiral-bound &quot;Pregnancy and Childbirth: A Goal Oriented Guide to Prenatal Care&quot;&#xD;
      created by the VA and DoD provides an innovative, cost-effective opportunity to improve&#xD;
      provider-patient communication and patient care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was conducted in the women's health and family medicine departments of one&#xD;
      community hospital and two medical centers across three states (Georgia, Nevada, and&#xD;
      Virginia). In this hospital system, women are distributed a spiral notebook at their&#xD;
      obstetric care intake appointment, which generally is scheduled for 8-10 weeks gestation. The&#xD;
      spiral notebook is designed for two purposes: 1) patient education of what happens throughout&#xD;
      pregnancy, and 2) patient record keeping of the patient's own pregnancy experience, including&#xD;
      space for recording weight, blood pressure, and journaling about what they experience between&#xD;
      prenatal appointments. The mobile app used in this study was designed for the same two&#xD;
      purposes and contained identical content, though through a mobile design interface (available&#xD;
      on both Android and iOS platforms). After the pilot study, patient feedback on the mobile app&#xD;
      was used to create a beta version. Notable differences were a feature for users to change&#xD;
      font size, a search function, and weekly reminders. No substantive content changed. This&#xD;
      randomized controlled study had one intervention (mobile application) and one control&#xD;
      (standard of care - spiral notebook) group. The study was approved by the first author's&#xD;
      Institutional Review Board.&#xD;
&#xD;
      At each medical center, the obstetrics intake nurse serially screened new obstetrics patients&#xD;
      for inclusion criteria from May to November 2015. If patients met inclusion criteria, the&#xD;
      nurse invited the patient to talk to a research assistant about the study. Exclusion criteria&#xD;
      included conditions that would elevate the patient's care to complicated obstetrics care&#xD;
      (e.g., cardiovascular disease, diabetes mellitus, renal disorder, etc.). This was intended to&#xD;
      capture a low-risk obstetrics patient population that would follow a standard 4-week pathway&#xD;
      of care, in which patients attend a prenatal appointment once every four weeks during&#xD;
      pregnancy.&#xD;
&#xD;
      The study used pre-assigned block randomization (each block n = 40) to balance the conditions&#xD;
      throughout recruitment. Following consent and baseline measures, participants were randomized&#xD;
      to the two conditions. Providers were blinded to patient participation in the study.&#xD;
&#xD;
      Surveys were completed at four prenatal appointments, 10-12 weeks, 28 weeks, 32 weeks, and 36&#xD;
      weeks gestation. All data collection was conducted with paper-and-pencil surveys in the&#xD;
      clinic, immediately before and following each clinical appointment. At each appointment,&#xD;
      patient weight and blood pressure were also recorded from the patient's electronic medical&#xD;
      record.&#xD;
&#xD;
      At baseline, self-reported measures included demographics, health literacy, and patient&#xD;
      activation. Health literacy was assessed using the self-reported Functional, Communicative,&#xD;
      Critical Health Literacy Scale (Ishikawa, Takeuchi, &amp; Yano, 2008) Patient activation was&#xD;
      assessed with the validated, licensed patient activation measure (PAM) (Greene &amp; Hibbard,&#xD;
      2012; Greene, Hibbard, Sacks, &amp; Overton, 2013; Hibbard, Mahoney, Stockard, &amp; Tusler, 2005;&#xD;
      Hibbard et al., 2004), which uses 13 Likert-type items to create a continuous patient&#xD;
      activation measure on a scale of 0 (not activated) to 100 (most activated). PAM was also&#xD;
      replicated at time 4 (32 week appointment). As a surrogate measure, patient activation was&#xD;
      also assessed at a behavioral level by asking patients at 36 weeks how many mobile apps they&#xD;
      had used throughout their pregnancy.&#xD;
&#xD;
      Use was assessed with three measures. Before each appointment, patients completed two items&#xD;
      regarding use of the education and engagement tool. First they indicated if they had brought&#xD;
      the mobile app/notebook to the appointment with them (yes/no). Then, they reported how&#xD;
      frequently they had used the tool over the past month 1) to look for information and 2) to&#xD;
      record information (never = 0, once = 1, weekly = 4, or daily = 28).&#xD;
&#xD;
      Following each appointment, patients completed five subscales of the validated Prenatal&#xD;
      Interpersonal Processes of Care (PIPC) scale (Wong et al., 2004), including&#xD;
      elicitation/responsiveness to the patient, explanations of care, empowerment,&#xD;
      patient-centered decision making, and emotional support. Responses to each item were&#xD;
      transformed onto a 0 (negative perception) to 100 (positive perception) scale, and items are&#xD;
      averaged to create subscales. Then subscales are averaged to calculate the overall PIPC&#xD;
      scale.&#xD;
&#xD;
      At delivery, outcomes were recorded from the health record: gestational age, birth weight,&#xD;
      and mode of delivery (vaginal or Caesarean section).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">August 30, 2015</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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Portability across time</measure>
    <time_frame>16-20 weeks gestation, 28 weeks gestation, 32 weeks gestation, 36 weeks gestation</time_frame>
    <description>Question if a patient brings tool to appointments and uses it between appointments</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient activation across time</measure>
    <time_frame>8-10 weeks gestation, 32 weeks gestation</time_frame>
    <description>Patient activation, defined as the knowledge, skills, and confidence to self-manage health</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prenatal Interpersonal Processes of Care across time</measure>
    <time_frame>16-20 weeks gestation, 28 weeks gestation, 32 weeks gestation, 36 weeks gestation</time_frame>
    <description>Patient perception of the prenatal providers communicative behavior</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">241</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Communication modality: spiral notebook</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Communication modality: mobile application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spiral notebook</intervention_name>
    <arm_group_label>Communication modality: spiral notebook</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile application</intervention_name>
    <arm_group_label>Communication modality: mobile application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Women (older than 18 years) who initiate obstetrics care (in the Women's Health or Family&#xD;
        Health clinics) at the three sites.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria in this study follow the guidelines for patients who are escalated in&#xD;
        obstetrical care, to include…&#xD;
&#xD;
          1. Cardiovascular disease&#xD;
&#xD;
          2. Cardiac abnormality&#xD;
&#xD;
          3. Diabetes Mellitus - Type I or Type II&#xD;
&#xD;
          4. Renal disorder&#xD;
&#xD;
          5. Uncontrolled hypertension&#xD;
&#xD;
          6. HIV positive&#xD;
&#xD;
          7. Hepatitis B or C positive&#xD;
&#xD;
          8. History of syphilis/RPR positive&#xD;
&#xD;
          9. Uncontrolled thyroid disease&#xD;
&#xD;
         10. History of previous bariatric surgery&#xD;
&#xD;
         11. Hematologic conditional with the exception of mild anemia&#xD;
&#xD;
         12. Cancer: current or recurrent&#xD;
&#xD;
         13. History of seizure disorder or other neurological condition&#xD;
&#xD;
         14. History of lupus or other autoimmune disorder&#xD;
&#xD;
         15. Antiphospholipid syndrome&#xD;
&#xD;
         16. History of transplant&#xD;
&#xD;
         17. History of genetics disease with known effect on pregnancy&#xD;
&#xD;
         18. Chronic pulmonary disease with the exception of well controlled&#xD;
&#xD;
         19. History of inflammatory bowel disease&#xD;
&#xD;
         20. Thromboembolic disease: current or previous&#xD;
&#xD;
         21. Recurrent pregnancy loss&#xD;
&#xD;
         22. History of isoimmunization&#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>
  <reference>
    <citation>Ledford CJW, Canzona MR, Cafferty LA, Hodge JA. Mobile application as a prenatal education and engagement tool: A randomized controlled pilot. Patient Educ Couns. 2016 Apr;99(4):578-582. doi: 10.1016/j.pec.2015.11.006. Epub 2015 Nov 10.</citation>
    <PMID>26610389</PMID>
  </reference>
  <results_reference>
    <citation>Ledford CJW, Womack JJ, Rider HA, Seehusen AB, Conner SJ, Lauters RA, Hodge JA. Unexpected Effects of a System-Distributed Mobile Application in Maternity Care: A Randomized Controlled Trial. Health Educ Behav. 2018 Jun;45(3):323-330. doi: 10.1177/1090198117732110. Epub 2017 Sep 16.</citation>
    <PMID>28918669</PMID>
  </results_reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03305003
org study id: FAM 81-3193
nct id: NCT03305003
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Throughout the Military Health System, pregnant mothers are issued a spiral-bound guide that
      provides week by week information about pregnancy, preventive health messages, appointment
      information, and space to record their experiences throughout their pregnancy. When used
      accordingly, the evidence-based guide is an effective tool for motivating patients to
      participate in their own healthcare and achieve care goals. However, the spiral-bound paper
      modality results in patients forgetting the book for appointments or losing it. By testing a
      mobile application (app) from the current publication, the MHS leverages the efforts which
      created the guide while increasing patient and provider use.

      The multisite testing (randomized controlled trial) of a mobile application developed from
      the current spiral-bound "Pregnancy and Childbirth: A Goal Oriented Guide to Prenatal Care"
      created by the VA and DoD provides an innovative, cost-effective opportunity to improve
      provider-patient communication and patient care.
The study was conducted in the women's health and family medicine departments of one
      community hospital and two medical centers across three states (Georgia, Nevada, and
      Virginia). In this hospital system, women are distributed a spiral notebook at their
      obstetric care intake appointment, which generally is scheduled for 8-10 weeks gestation. The
      spiral notebook is designed for two purposes: 1) patient education of what happens throughout
      pregnancy, and 2) patient record keeping of the patient's own pregnancy experience, including
      space for recording weight, blood pressure, and journaling about what they experience between
      prenatal appointments. The mobile app used in this study was designed for the same two
      purposes and contained identical content, though through a mobile design interface (available
      on both Android and iOS platforms). After the pilot study, patient feedback on the mobile app
      was used to create a beta version. Notable differences were a feature for users to change
      font size, a search function, and weekly reminders. No substantive content changed. This
      randomized controlled study had one intervention (mobile application) and one control
      (standard of care - spiral notebook) group. The study was approved by the first author's
      Institutional Review Board.

      At each medical center, the obstetrics intake nurse serially screened new obstetrics patients
      for inclusion criteria from May to November 2015. If patients met inclusion criteria, the
      nurse invited the patient to talk to a research assistant about the study. Exclusion criteria
      included conditions that would elevate the patient's care to complicated obstetrics care
      (e.g., cardiovascular disease, diabetes mellitus, renal disorder, etc.). This was intended to
      capture a low-risk obstetrics patient population that would follow a standard 4-week pathway
      of care, in which patients attend a prenatal appointment once every four weeks during
      pregnancy.

      The study used pre-assigned block randomization (each block n = 40) to balance the conditions
      throughout recruitment. Following consent and baseline measures, participants were randomized
      to the two conditions. Providers were blinded to patient participation in the study.

      Surveys were completed at four prenatal appointments, 10-12 weeks, 28 weeks, 32 weeks, and 36
      weeks gestation. All data collection was conducted with paper-and-pencil surveys in the
      clinic, immediately before and following each clinical appointment. At each appointment,
      patient weight and blood pressure were also recorded from the patient's electronic medical
      record.

      At baseline, self-reported measures included demographics, health literacy, and patient
      activation. Health literacy was assessed using the self-reported Functional, Communicative,
      Critical Health Literacy Scale (Ishikawa, Takeuchi, & Yano, 2008) Patient activation was
      assessed with the validated, licensed patient activation measure (PAM) (Greene & Hibbard,
      2012; Greene, Hibbard, Sacks, & Overton, 2013; Hibbard, Mahoney, Stockard, & Tusler, 2005;
      Hibbard et al., 2004), which uses 13 Likert-type items to create a continuous patient
      activation measure on a scale of 0 (not activated) to 100 (most activated). PAM was also
      replicated at time 4 (32 week appointment). As a surrogate measure, patient activation was
      also assessed at a behavioral level by asking patients at 36 weeks how many mobile apps they
      had used throughout their pregnancy.

      Use was assessed with three measures. Before each appointment, patients completed two items
      regarding use of the education and engagement tool. First they indicated if they had brought
      the mobile app/notebook to the appointment with them (yes/no). Then, they reported how
      frequently they had used the tool over the past month 1) to look for information and 2) to
      record information (never = 0, once = 1, weekly = 4, or daily = 28).

      Following each appointment, patients completed five subscales of the validated Prenatal
      Interpersonal Processes of Care (PIPC) scale (Wong et al., 2004), including
      elicitation/responsiveness to the patient, explanations of care, empowerment,
      patient-centered decision making, and emotional support. Responses to each item were
      transformed onto a 0 (negative perception) to 100 (positive perception) scale, and items are
      averaged to create subscales. Then subscales are averaged to calculate the overall PIPC
      scale.

      At delivery, outcomes were recorded from the health record: gestational age, birth weight,
      and mode of delivery (vaginal or Caesarean section).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Care Provider)
measure: Portability across time
time frame: 16-20 weeks gestation, 28 weeks gestation, 32 weeks gestation, 36 weeks gestation
description: Question if a patient brings tool to appointments and uses it between appointments
measure: Patient activation across time
time frame: 8-10 weeks gestation, 32 weeks gestation
description: Patient activation, defined as the knowledge, skills, and confidence to self-manage health
measure: Prenatal Interpersonal Processes of Care across time
time frame: 16-20 weeks gestation, 28 weeks gestation, 32 weeks gestation, 36 weeks gestation
description: Patient perception of the prenatal providers communicative behavior
arm group label: Communication modality: spiral notebook
arm group type: Active Comparator
arm group label: Communication modality: mobile application
arm group type: Experimental
intervention type: Other
intervention name: Spiral notebook
arm group label: Communication modality: spiral notebook
intervention type: Other
intervention name: Mobile application
arm group label: Communication modality: mobile application
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
citation: Ledford CJW, Canzona MR, Cafferty LA, Hodge JA. Mobile application as a prenatal education and engagement tool: A randomized controlled pilot. Patient Educ Couns. 2016 Apr;99(4):578-582. doi: 10.1016/j.pec.2015.11.006. Epub 2015 Nov 10.
PMID: 26610389
citation: Ledford CJW, Womack JJ, Rider HA, Seehusen AB, Conner SJ, Lauters RA, Hodge JA. Unexpected Effects of a System-Distributed Mobile Application in Maternity Care: A Randomized Controlled Trial. Health Educ Behav. 2018 Jun;45(3):323-330. doi: 10.1177/1090198117732110. Epub 2017 Sep 16.
PMID: 28918669
responsible party type: Sponsor
sharing ipd: No