<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/NCT04480255</url>
  </required_header>
  <id_info>
    <org_study_id>STU00212196</org_study_id>
    <nct_id>NCT04480255</nct_id>
  </id_info>
  <brief_title>NICU2HOME+: Supporting Illinois Families</brief_title>
  <official_title>NICU2HOME+: Supporting Illinois Families of Premature Infants With Smartphone Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Craig Garfield</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Blue Cross Blue Shield</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</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>
      The purpose of this project is to provide a stepwise, methodical approach to developing and&#xD;
      testing the ability of NICU2HOME+ to support diverse Illinois families of premature infants&#xD;
      during and after their NICU stays in an effort to address health equity, improve parenting,&#xD;
      and reduce costs. There are 3 objectives of the study: 1) Identify and assess the&#xD;
      requirements for expansion of NICU2HOME+, a suite of mobile patient education and engagement&#xD;
      applications with EMR integration that is culturally appropriate and customized to the needs&#xD;
      of a diverse population of patients and families to 3 additional level III Illinois NICUS; 2)&#xD;
      develop and deploy NICU2HOME+ to these 3 additional NICUs; and 3)determine if it is effective&#xD;
      in: a) addressing health equity issues, b) improving parenting self-efficacy and&#xD;
      satisfaction, and c) improving NICU outcomes such as a reduced length of stay and lower&#xD;
      readmission rates that result in lower healthcare costs.&#xD;
&#xD;
      All research recruitment and participation will take place in the following spaces:&#xD;
&#xD;
        1. Northwestern Medicine's Central Dupage Hospital (25 N.Winfield Rd., Winfield, IL)- NICU,&#xD;
           Postpartum, and Research Offices&#xD;
&#xD;
        2. Northwest Community Hospital (800 W. Central Rd., Arlington Heights, IL)-&#xD;
           NICU,Postpartum, and Research Offices&#xD;
&#xD;
        3. Rush University Medical Center (Chicago, IL)- NICU, Postpartum, and Research Offices&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose to address the goals of the Affordability Cures Initiative and&#xD;
      promote health equity by developing NICU2HOME+, a smartphone app designed to support NICU&#xD;
      parents in a culturally appropriate manner in community level III NICUs in Illinois and to&#xD;
      include EMR integration. Mobile technology such as NICU2HOME+ offers an innovative way to&#xD;
      reduce costs in two ways. First, parents who are better informed and supported, who feel more&#xD;
      confident and competent in caring for their premature infants, may be more prepared for an&#xD;
      earlier discharge. Second, cost savings may be realized after discharge, if better educated&#xD;
      and more competent parents are less likely to inappropriately visit the ER or their infant's&#xD;
      physicians as they know what to expect and can provide better, more competent care to their&#xD;
      baby. At its center, NICU2HOME+is able to achieve four &quot;rights&quot; of adaptive personalization&#xD;
      and parent-centric care: delivering the &quot;right&quot; information at the &quot;right&quot; time to the&#xD;
      &quot;right&quot; person via the &quot;right&quot; medium. The ultimate goal of this proposal, therefore, is to&#xD;
      develop a scalable, evidence-based.&#xD;
&#xD;
      Participants will be divided into two research groups based on when their infant was born.&#xD;
      The first group, parents of infants born between June 15th and December 31st 2020, will&#xD;
      receive the standard care provided in the NICU. The second group of participants, those with&#xD;
      infants born between January 1 and July 31 2021, will also receive the NICU standard care and&#xD;
      additionally be asked to use a smartphone app related to NICU and at-home care. Participation&#xD;
      in the second groups requires ownership of a smartphone and the ability to use a smartphone&#xD;
      app.&#xD;
&#xD;
      If the participant has been assigned to the first group, the investigators would like both&#xD;
      parents to participate in the study independently and therefore complete individual consent&#xD;
      forms. However, the investigators recognize not all families will have two parents that are&#xD;
      interested or able to participate and ultimately participation from some families will&#xD;
      include only one parent.&#xD;
&#xD;
      As part of the study, participants will be asked to complete four surveys. They will be&#xD;
      administered at the time of admission, infant's discharge from the NICU, fourteen days after&#xD;
      discharge and thirty days after discharge. For those families who have a longer stay in the&#xD;
      NICU, the investigators will ask parents to complete two additional surveys; one 30 days&#xD;
      after admission and one 60 days after admission.Each survey will take approximately five to&#xD;
      ten minutes to complete. The main benefit of participation is that this research that may&#xD;
      help improve the NICU experience for other families in the future. The primary risk of&#xD;
      participation is the potential loss of confidentiality, but strict measures are in place to&#xD;
      minimize the chance of this happening.&#xD;
&#xD;
      In addition, if participants agree to the option at the end of this Consent Form,&#xD;
      participants may or may not be invited to participate in a separate research interview to&#xD;
      take place during the participants NICU stay, around the time of the infant's discharge from&#xD;
      the hospital, or within a year of the transition to home. These optional, voluntary&#xD;
      interviews will be conducted at a time, location and method (phone or in-person) agreed upon&#xD;
      by the parent. All interviews will be conducted with our research staff with experience&#xD;
      interviewing parents of NICU graduates. While the investigators encourage both parents to&#xD;
      participate in order to hear about differences in experiences, one or both parents can&#xD;
      ultimately participate. The purpose of the research interview is to better understand&#xD;
      participants' experience in the NICU and at home as the parent of a premature infant.&#xD;
&#xD;
      Participants will be divided into two research groups based on when their infant was born.&#xD;
      The first group, parents of infants born between July 15th and December 31st 2020, will&#xD;
      receive the standard care provided in the NICU. The second group of participants, those with&#xD;
      infants born between January 1 and July 31 2021, will also receive the NICU standard care and&#xD;
      additionally be asked to use a smartphone app related to NICU and at-home care. Participation&#xD;
      in the second groups requires ownership of a smartphone and the ability to use a smartphone&#xD;
      app.&#xD;
&#xD;
      If a participants are assigned to the first or second groups, the investigators would like&#xD;
      both parents to participate in the study independently and therefore complete individual&#xD;
      consent forms. However, the investigators recognize not all families will have two parents&#xD;
      that are interested or able to participate and ultimately participation from some families&#xD;
      will include only one parent.&#xD;
&#xD;
      As part of the study, participants will be asked to complete four surveys. They will be&#xD;
      administered at the time of admission, infant's discharge from the NICU, fourteen days after&#xD;
      discharge and thirty days after discharge. For those families who have a longer stay in the&#xD;
      NICU, the investigators will ask parents to complete two additional surveys; one 30 days&#xD;
      after admission and one 60 days after admission. Each survey will take approximately five to&#xD;
      ten minutes to complete. The main benefit of participation is that this research that may&#xD;
      help improve the NICU experience for other families in the future. The primary risk of&#xD;
      participation is the potential loss of confidentiality, but strict measures are in place to&#xD;
      minimize the chance of this happening.&#xD;
&#xD;
      In addition, if participants agree to the option at the end of this Consent Form,&#xD;
      participants may or may not be invited to participate in a separate research interview to&#xD;
      take place during the participants' NICU stay, around the time of the participants' infant's&#xD;
      discharge from the hospital, or within a year of the participants transition home. These&#xD;
      optional, voluntary interviews will be conducted at a time, location and method (phone or&#xD;
      in-person) agreed upon by the parent. All interviews will be conducted with our research&#xD;
      staff with experience interviewing parents of NICU graduates. While the investigators&#xD;
      encourage both parents to participate in order to hear about differences in experiences, one&#xD;
      or both parents can ultimately participate. The purpose of the research interview is to&#xD;
      better understand the participants' experience in the NICU and at home as the parent of a&#xD;
      premature infant.&#xD;
&#xD;
      Optional Interview:&#xD;
&#xD;
      In addition to the intervention study, optional qualitative interviews will be conducted with&#xD;
      participants using a maximum variability approach. Interviews will focus on the following:&#xD;
&#xD;
        -  Their overall experience of using the app&#xD;
&#xD;
        -  Educational Content&#xD;
&#xD;
        -  Relationship/communication through app with extended family/friends&#xD;
&#xD;
        -  Readiness for discharge&#xD;
&#xD;
        -  Empowerment, ability to communicate better with doctors and nurses, and being able to&#xD;
           participate in child health care confidently&#xD;
&#xD;
        -  Being ready to go home and did the app help&#xD;
&#xD;
        -  Information, communication and support needs across the NICU stay, discharge and beyond&#xD;
&#xD;
      This voluntary interview will be described to parents at the time of consent. To maintain&#xD;
      confidentiality all subjects will be given a unique study code (PIN) and all information&#xD;
      collected for app development will be linked to that number, not to any other identifier. All&#xD;
      documents that include identifiers will be stored in a locked, secure location that only key&#xD;
      authorized study personnel (e.g. PI, research team members) will have access to.&#xD;
&#xD;
      The interviews will be audio recorded. The recordings will be given an ID number and kept in&#xD;
      locked cabinets and on secure computers. The audio recordings will be transcribed and kept on&#xD;
      password protected computers. (There will be no personal identifiers (such as names) in the&#xD;
      transcribed documents.) After the recordings are transcribed, the audio files will be erased.&#xD;
&#xD;
      Only the people listed on the Authorized Research Personnel list will have access to the&#xD;
      data. All paper data will be kept in locked files and rooms. Electronic data will be kept in&#xD;
      on password- encrypted computers and files with identifying information will be individually&#xD;
      password protected. Names and contact information will be stored only for the purpose of&#xD;
      contacting participants. This information will be stored separately from study data and the&#xD;
      two will only be linked by a study ID, kept in a password protected document. Upon completion&#xD;
      of data collection all name and contact information as will be destroyed by file deletion.&#xD;
      All data collected for this study will be kept in a locked, secure location and anything that&#xD;
      can be destroyed (deleted, shredded, etc.) after it has been coded, will be.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mobile Application Outcome 1</measure>
    <time_frame>2-3 months</time_frame>
    <description>The primary outcome measure understand how the smartphone application improves patient/parent experiences in the NICU. This will be measured through a survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mobile Application Outcome 2</measure>
    <time_frame>2-3 months</time_frame>
    <description>The primary outcome measure will addressing the association of the smartphone application with parenting self-efficacy to improve infants' and parents' health outcomes. This will be measured through a survey.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>2-3 months</time_frame>
    <description>Patient anxiety will be measured through a survey. The response options range from 1 to 4 (Almost never, Sometimes, Often, and Almost always)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Sense of Competence Scale (PSOC)</measure>
    <time_frame>2-3 months</time_frame>
    <description>Self-efficacy will be measured through a survey. The response options range from 1 to 6 (Strongly Disagree to Strongly Agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Edinburgh Postnatal Depression Scale (EPDS)</measure>
    <time_frame>2-3 months</time_frame>
    <description>Depression will be measured through a survey. The response options range from 0 (for example, no, not at all or no, never again) to 3 (for example, yes, most of the time or yes, very often). The total score ranges from 0 to 30, where higher values indicate more severe symptoms of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Press Ganey Questionnaire (PG)</measure>
    <time_frame>2-3 months</time_frame>
    <description>Measures all aspects of patient satisfaction during hospital stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare encounters (HE)</measure>
    <time_frame>2-3 months</time_frame>
    <description>Patient satisfaction of healthcare provider's will be measured through survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rate (RR)</measure>
    <time_frame>2-3 months</time_frame>
    <description>Readmission rates will be measured through a survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User Version of the Mobile Application Rating Scale (uMARS)</measure>
    <time_frame>2-3 months</time_frame>
    <description>Quality and reliability of mobile application will be measured through a survey. All items are rated on a 5-point scale from &quot;1. Inadequate&quot; to &quot;5. Excellent&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perinatal PTSD Questionnaire - Modified (PPQ-M)</measure>
    <time_frame>2-3 months</time_frame>
    <description>Perinatal Post-Traumatic Stress Disorder (PTSD) will be measured through a survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID-19 Impact Scale</measure>
    <time_frame>2-3 months</time_frame>
    <description>Given the uncertainty of the global pandemic, we measuring if COVID will have an impact on the use of the mobile application.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>2-3 months</time_frame>
    <description>Stress will be measured through a survey. The response options range from 1 to 4 (Never Almost; Never Sometimes; Fairly Often; Very Often). The total score ranges from 0 to 16, where higher values indicate more severe symptoms of stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MOS- Social Support Scale (MOS)</measure>
    <time_frame>2-3 months</time_frame>
    <description>Social Support will be measured through a survey. The response options range from 1 to 5 (None of the time - All of the time). The survey consists of four separate social support subscales and an overall functional social support index. A higher score for an individual scale or for the overall support index indicates more support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Behavior (HB)</measure>
    <time_frame>2-3 months</time_frame>
    <description>Health behavior questions relating to physical health, mental health, stress, breastfeeding, and reproductive health will be measured through a survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CDC- Hear Her Campaign</measure>
    <time_frame>2-3 months</time_frame>
    <description>Questions surrounding maternal mortality and morbidity will be asked through a survey.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">413</enrollment>
  <condition>Premature Birth</condition>
  <condition>NICU</condition>
  <condition>Premature</condition>
  <condition>Infant</condition>
  <arm_group>
    <arm_group_label>Group 1: Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Parents of infants born from date July 2020-December 2020</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: NICU2HOME+ app</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Parents of infants born from mid Jan 2021-May2021</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group 1: Standard of Care</intervention_name>
    <description>Those who are in Group 1 will receive the usual care which includes:&#xD;
a welcome packet from the nursing staff&#xD;
access to their infant's medical team including doctors and nurse&#xD;
opportunities to ask any questions and understand the care their baby is receiving through participation in daily work rounds or through setting up family meetings with the medical team.</description>
    <arm_group_label>Group 1: Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group 2: NICU2HOME+ app</intervention_name>
    <description>In addition to the usual care made available to Group 1 as described above, Group 2 parents will receive the smartphone app. Group 2 parents will be asked to download the NICU2HOME app.</description>
    <arm_group_label>Group 2: NICU2HOME+ app</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents (including single parents) of premature infants (&lt;35 weeks) admitted to&#xD;
             Central Dupage Hospital (CDH), Northwest Community Hospital (NCH), and Rush University&#xD;
             Medical Center (RUSH)&#xD;
&#xD;
          -  Infants born prematurely with a gestational age of &lt;35 weeks&#xD;
&#xD;
          -  Minimum stay in NICU of 7 days&#xD;
&#xD;
          -  Competent in English or Spanish (i.e. to fully understand the questions asked in the&#xD;
             surveys)&#xD;
&#xD;
          -  Smartphone owner&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-adults unable to consent/Cognitively Impaired&#xD;
&#xD;
          -  Prisoners or other detained individuals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua Santiago, MA</last_name>
    <role>Study Director</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwest Community Hospital</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centra Dupage Hospital</name>
      <address>
        <city>Winfield</city>
        <state>Illinois</state>
        <zip>60192</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press (US); 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK11362/</citation>
    <PMID>20669423</PMID>
  </reference>
  <reference>
    <citation>Garfield CF, Lee Y, Kim HN. Paternal and maternal concerns for their very low-birth-weight infants transitioning from the NICU to home. J Perinat Neonatal Nurs. 2014 Oct-Dec;28(4):305-12. doi: 10.1097/JPN.0000000000000021.</citation>
    <PMID>24927295</PMID>
  </reference>
  <reference>
    <citation>Braveman P. What is health equity: and how does a life-course approach take us further toward it? Matern Child Health J. 2014 Feb;18(2):366-72. doi: 10.1007/s10995-013-1226-9.</citation>
    <PMID>23397099</PMID>
  </reference>
  <reference>
    <citation>Blumenshine P, Egerter S, Barclay CJ, Cubbin C, Braveman PA. Socioeconomic disparities in adverse birth outcomes: a systematic review. Am J Prev Med. 2010 Sep;39(3):263-72. doi: 10.1016/j.amepre.2010.05.012.</citation>
    <PMID>20709259</PMID>
  </reference>
  <reference>
    <citation>MacDorman MF. Race and ethnic disparities in fetal mortality, preterm birth, and infant mortality in the United States: an overview. Semin Perinatol. 2011 Aug;35(4):200-8. doi: 10.1053/j.semperi.2011.02.017.</citation>
    <PMID>21798400</PMID>
  </reference>
  <reference>
    <citation>Pew Research Center: Internet Science &amp; Technology. Mobile technology fact sheet. 2018; http://www.pewinternet.org/fact-sheet/mobile/. Accessed January 14, 2019, 2015.</citation>
  </reference>
  <reference>
    <citation>Anderson-Lewis C, Darville G, Mercado RE, Howell S, Di Maggio S. mHealth Technology Use and Implications in Historically Underserved and Minority Populations in the United States: Systematic Literature Review. JMIR Mhealth Uhealth. 2018 Jun 18;6(6):e128. doi: 10.2196/mhealth.8383.</citation>
    <PMID>29914860</PMID>
  </reference>
  <reference>
    <citation>Anoshiravani A, Gaskin G, Kopetsky E, Sandborg C, Longhurst CA. Implementing an Interoperable Personal Health Record in Pediatrics: Lessons Learned at an Academic Children's Hospital. J Particip Med. 2011 Jul 10;3:e30.</citation>
    <PMID>21853160</PMID>
  </reference>
  <reference>
    <citation>Cooper LG, Gooding JS, Gallagher J, Sternesky L, Ledsky R, Berns SD. Impact of a family-centered care initiative on NICU care, staff and families. J Perinatol. 2007 Dec;27 Suppl 2:S32-7. doi: 10.1038/sj.jp.7211840.</citation>
    <PMID>18034178</PMID>
  </reference>
  <reference>
    <citation>De Rouck S, Leys M. Information needs of parents of children admitted to a neonatal intensive care unit: a review of the literature (1990-2008). Patient Educ Couns. 2009 Aug;76(2):159-73. doi: 10.1016/j.pec.2009.01.014. Epub 2009 Mar 24.</citation>
    <PMID>19321288</PMID>
  </reference>
  <reference>
    <citation>Escobar GJ, Joffe S, Gardner MN, Armstrong MA, Folck BF, Carpenter DM. Rehospitalization in the first two weeks after discharge from the neonatal intensive care unit. Pediatrics. 1999 Jul;104(1):e2. doi: 10.1542/peds.104.1.e2.</citation>
    <PMID>10390288</PMID>
  </reference>
  <reference>
    <citation>Garfield CF, Lee YS, Kim HN, Rutsohn J, Kahn JY, Mustanski B, Mohr DC. Supporting Parents of Premature Infants Transitioning from the NICU to Home: A Pilot Randomized Control Trial of a Smartphone Application. Internet Interv. 2016 May;4(Pt 2):131-137. doi: 10.1016/j.invent.2016.05.004. Epub 2016 Jun 4.</citation>
    <PMID>27990350</PMID>
  </reference>
  <reference>
    <citation>Kim HN, Garfield C, Lee YS. Paternal and maternal information and communication technology usage as their very low birth weight infants transition home from the NICU. Int J Hum Comput Interact. 2015;31(1):44-54.</citation>
  </reference>
  <reference>
    <citation>Lee Y, Garfield C, Massey N, Chaysinh S, Hassan S. NICU-2-home: Supporting the transition to home from the neonatal intensive care unit using a mobile application. Conference on Human Factors in Computing Systems; May 7 - 11,</citation>
  </reference>
  <reference>
    <citation>Gilmore L, Cuskelly M. Factor structure of the Parenting Sense of Competence scale using a normative sample. Child Care Health Dev. 2009 Jan;35(1):48-55. doi: 10.1111/j.1365-2214.2008.00867.x. Epub 2008 Oct 22.</citation>
    <PMID>18991983</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>June 1, 2023</last_update_submitted>
  <last_update_submitted_qc>June 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Craig Garfield</investigator_full_name>
    <investigator_title>Professor of Pediatrics; and Attending physician and neonatal hospitalist at the Lurie Children's Hospital of Chicago where he is the Director of Research for the Division</investigator_title>
  </responsible_party>
  <keyword>Premature Infant; NICU</keyword>
  <keyword>Premature Birth</keyword>
  <keyword>Smartphone App</keyword>
  <keyword>NICU</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT04480255/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04480255
org study id: STU00212196
nct id: NCT04480255
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this project is to provide a stepwise, methodical approach to developing and
      testing the ability of NICU2HOME+ to support diverse Illinois families of premature infants
      during and after their NICU stays in an effort to address health equity, improve parenting,
      and reduce costs. There are 3 objectives of the study: 1) Identify and assess the
      requirements for expansion of NICU2HOME+, a suite of mobile patient education and engagement
      applications with EMR integration that is culturally appropriate and customized to the needs
      of a diverse population of patients and families to 3 additional level III Illinois NICUS; 2)
      develop and deploy NICU2HOME+ to these 3 additional NICUs; and 3)determine if it is effective
      in: a) addressing health equity issues, b) improving parenting self-efficacy and
      satisfaction, and c) improving NICU outcomes such as a reduced length of stay and lower
      readmission rates that result in lower healthcare costs.

      All research recruitment and participation will take place in the following spaces:

        1. Northwestern Medicine's Central Dupage Hospital (25 N.Winfield Rd., Winfield, IL)- NICU,
           Postpartum, and Research Offices

        2. Northwest Community Hospital (800 W. Central Rd., Arlington Heights, IL)-
           NICU,Postpartum, and Research Offices

        3. Rush University Medical Center (Chicago, IL)- NICU, Postpartum, and Research Offices
The investigators propose to address the goals of the Affordability Cures Initiative and
      promote health equity by developing NICU2HOME+, a smartphone app designed to support NICU
      parents in a culturally appropriate manner in community level III NICUs in Illinois and to
      include EMR integration. Mobile technology such as NICU2HOME+ offers an innovative way to
      reduce costs in two ways. First, parents who are better informed and supported, who feel more
      confident and competent in caring for their premature infants, may be more prepared for an
      earlier discharge. Second, cost savings may be realized after discharge, if better educated
      and more competent parents are less likely to inappropriately visit the ER or their infant's
      physicians as they know what to expect and can provide better, more competent care to their
      baby. At its center, NICU2HOME+is able to achieve four "rights" of adaptive personalization
      and parent-centric care: delivering the "right" information at the "right" time to the
      "right" person via the "right" medium. The ultimate goal of this proposal, therefore, is to
      develop a scalable, evidence-based.

      Participants will be divided into two research groups based on when their infant was born.
      The first group, parents of infants born between June 15th and December 31st 2020, will
      receive the standard care provided in the NICU. The second group of participants, those with
      infants born between January 1 and July 31 2021, will also receive the NICU standard care and
      additionally be asked to use a smartphone app related to NICU and at-home care. Participation
      in the second groups requires ownership of a smartphone and the ability to use a smartphone
      app.

      If the participant has been assigned to the first group, the investigators would like both
      parents to participate in the study independently and therefore complete individual consent
      forms. However, the investigators recognize not all families will have two parents that are
      interested or able to participate and ultimately participation from some families will
      include only one parent.

      As part of the study, participants will be asked to complete four surveys. They will be
      administered at the time of admission, infant's discharge from the NICU, fourteen days after
      discharge and thirty days after discharge. For those families who have a longer stay in the
      NICU, the investigators will ask parents to complete two additional surveys; one 30 days
      after admission and one 60 days after admission.Each survey will take approximately five to
      ten minutes to complete. The main benefit of participation is that this research that may
      help improve the NICU experience for other families in the future. The primary risk of
      participation is the potential loss of confidentiality, but strict measures are in place to
      minimize the chance of this happening.

      In addition, if participants agree to the option at the end of this Consent Form,
      participants may or may not be invited to participate in a separate research interview to
      take place during the participants NICU stay, around the time of the infant's discharge from
      the hospital, or within a year of the transition to home. These optional, voluntary
      interviews will be conducted at a time, location and method (phone or in-person) agreed upon
      by the parent. All interviews will be conducted with our research staff with experience
      interviewing parents of NICU graduates. While the investigators encourage both parents to
      participate in order to hear about differences in experiences, one or both parents can
      ultimately participate. The purpose of the research interview is to better understand
      participants' experience in the NICU and at home as the parent of a premature infant.

      Participants will be divided into two research groups based on when their infant was born.
      The first group, parents of infants born between July 15th and December 31st 2020, will
      receive the standard care provided in the NICU. The second group of participants, those with
      infants born between January 1 and July 31 2021, will also receive the NICU standard care and
      additionally be asked to use a smartphone app related to NICU and at-home care. Participation
      in the second groups requires ownership of a smartphone and the ability to use a smartphone
      app.

      If a participants are assigned to the first or second groups, the investigators would like
      both parents to participate in the study independently and therefore complete individual
      consent forms. However, the investigators recognize not all families will have two parents
      that are interested or able to participate and ultimately participation from some families
      will include only one parent.

      As part of the study, participants will be asked to complete four surveys. They will be
      administered at the time of admission, infant's discharge from the NICU, fourteen days after
      discharge and thirty days after discharge. For those families who have a longer stay in the
      NICU, the investigators will ask parents to complete two additional surveys; one 30 days
      after admission and one 60 days after admission. Each survey will take approximately five to
      ten minutes to complete. The main benefit of participation is that this research that may
      help improve the NICU experience for other families in the future. The primary risk of
      participation is the potential loss of confidentiality, but strict measures are in place to
      minimize the chance of this happening.

      In addition, if participants agree to the option at the end of this Consent Form,
      participants may or may not be invited to participate in a separate research interview to
      take place during the participants' NICU stay, around the time of the participants' infant's
      discharge from the hospital, or within a year of the participants transition home. These
      optional, voluntary interviews will be conducted at a time, location and method (phone or
      in-person) agreed upon by the parent. All interviews will be conducted with our research
      staff with experience interviewing parents of NICU graduates. While the investigators
      encourage both parents to participate in order to hear about differences in experiences, one
      or both parents can ultimately participate. The purpose of the research interview is to
      better understand the participants' experience in the NICU and at home as the parent of a
      premature infant.

      Optional Interview:

      In addition to the intervention study, optional qualitative interviews will be conducted with
      participants using a maximum variability approach. Interviews will focus on the following:

        -  Their overall experience of using the app

        -  Educational Content

        -  Relationship/communication through app with extended family/friends

        -  Readiness for discharge

        -  Empowerment, ability to communicate better with doctors and nurses, and being able to
           participate in child health care confidently

        -  Being ready to go home and did the app help

        -  Information, communication and support needs across the NICU stay, discharge and beyond

      This voluntary interview will be described to parents at the time of consent. To maintain
      confidentiality all subjects will be given a unique study code (PIN) and all information
      collected for app development will be linked to that number, not to any other identifier. All
      documents that include identifiers will be stored in a locked, secure location that only key
      authorized study personnel (e.g. PI, research team members) will have access to.

      The interviews will be audio recorded. The recordings will be given an ID number and kept in
      locked cabinets and on secure computers. The audio recordings will be transcribed and kept on
      password protected computers. (There will be no personal identifiers (such as names) in the
      transcribed documents.) After the recordings are transcribed, the audio files will be erased.

      Only the people listed on the Authorized Research Personnel list will have access to the
      data. All paper data will be kept in locked files and rooms. Electronic data will be kept in
      on password- encrypted computers and files with identifying information will be individually
      password protected. Names and contact information will be stored only for the purpose of
      contacting participants. This information will be stored separately from study data and the
      two will only be linked by a study ID, kept in a password protected document. Upon completion
      of data collection all name and contact information as will be destroyed by file deletion.
      All data collected for this study will be kept in a locked, secure location and anything that
      can be destroyed (deleted, shredded, etc.) after it has been coded, will be.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Mobile Application Outcome 1
time frame: 2-3 months
description: The primary outcome measure understand how the smartphone application improves patient/parent experiences in the NICU. This will be measured through a survey.
measure: Mobile Application Outcome 2
time frame: 2-3 months
description: The primary outcome measure will addressing the association of the smartphone application with parenting self-efficacy to improve infants' and parents' health outcomes. This will be measured through a survey.
measure: State-Trait Anxiety Inventory (STAI)
time frame: 2-3 months
description: Patient anxiety will be measured through a survey. The response options range from 1 to 4 (Almost never, Sometimes, Often, and Almost always)
measure: Parenting Sense of Competence Scale (PSOC)
time frame: 2-3 months
description: Self-efficacy will be measured through a survey. The response options range from 1 to 6 (Strongly Disagree to Strongly Agree)
measure: Edinburgh Postnatal Depression Scale (EPDS)
time frame: 2-3 months
description: Depression will be measured through a survey. The response options range from 0 (for example, no, not at all or no, never again) to 3 (for example, yes, most of the time or yes, very often). The total score ranges from 0 to 30, where higher values indicate more severe symptoms of depression.
measure: Press Ganey Questionnaire (PG)
time frame: 2-3 months
description: Measures all aspects of patient satisfaction during hospital stay.
measure: Healthcare encounters (HE)
time frame: 2-3 months
description: Patient satisfaction of healthcare provider's will be measured through survey.
measure: Readmission rate (RR)
time frame: 2-3 months
description: Readmission rates will be measured through a survey.
measure: User Version of the Mobile Application Rating Scale (uMARS)
time frame: 2-3 months
description: Quality and reliability of mobile application will be measured through a survey. All items are rated on a 5-point scale from "1. Inadequate" to "5. Excellent"
measure: Perinatal PTSD Questionnaire - Modified (PPQ-M)
time frame: 2-3 months
description: Perinatal Post-Traumatic Stress Disorder (PTSD) will be measured through a survey.
measure: COVID-19 Impact Scale
time frame: 2-3 months
description: Given the uncertainty of the global pandemic, we measuring if COVID will have an impact on the use of the mobile application.
measure: Perceived Stress Scale (PSS)
time frame: 2-3 months
description: Stress will be measured through a survey. The response options range from 1 to 4 (Never Almost; Never Sometimes; Fairly Often; Very Often). The total score ranges from 0 to 16, where higher values indicate more severe symptoms of stress.
measure: MOS- Social Support Scale (MOS)
time frame: 2-3 months
description: Social Support will be measured through a survey. The response options range from 1 to 5 (None of the time - All of the time). The survey consists of four separate social support subscales and an overall functional social support index. A higher score for an individual scale or for the overall support index indicates more support.
measure: Health Behavior (HB)
time frame: 2-3 months
description: Health behavior questions relating to physical health, mental health, stress, breastfeeding, and reproductive health will be measured through a survey.
measure: CDC- Hear Her Campaign
time frame: 2-3 months
description: Questions surrounding maternal mortality and morbidity will be asked through a survey.
arm group label: Group 1: Standard of Care
arm group type: Active Comparator
description: Parents of infants born from date July 2020-December 2020
arm group label: Group 2: NICU2HOME+ app
arm group type: Active Comparator
description: Parents of infants born from mid Jan 2021-May2021
intervention type: Other
intervention name: Group 1: Standard of Care
description: Those who are in Group 1 will receive the usual care which includes:
a welcome packet from the nursing staff
access to their infant's medical team including doctors and nurse
opportunities to ask any questions and understand the care their baby is receiving through participation in daily work rounds or through setting up family meetings with the medical team.
arm group label: Group 1: Standard of Care
intervention type: Other
intervention name: Group 2: NICU2HOME+ app
description: In addition to the usual care made available to Group 1 as described above, Group 2 parents will receive the smartphone app. Group 2 parents will be asked to download the NICU2HOME app.
arm group label: Group 2: NICU2HOME+ app
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joshua Santiago, MA
role: Study Director
affiliation: Northwestern University
facility: 
facility: 
facility: 
country: United States
citation: Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press (US); 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK11362/
PMID: 20669423
citation: Garfield CF, Lee Y, Kim HN. Paternal and maternal concerns for their very low-birth-weight infants transitioning from the NICU to home. J Perinat Neonatal Nurs. 2014 Oct-Dec;28(4):305-12. doi: 10.1097/JPN.0000000000000021.
PMID: 24927295
citation: Braveman P. What is health equity: and how does a life-course approach take us further toward it? Matern Child Health J. 2014 Feb;18(2):366-72. doi: 10.1007/s10995-013-1226-9.
PMID: 23397099
citation: Blumenshine P, Egerter S, Barclay CJ, Cubbin C, Braveman PA. Socioeconomic disparities in adverse birth outcomes: a systematic review. Am J Prev Med. 2010 Sep;39(3):263-72. doi: 10.1016/j.amepre.2010.05.012.
PMID: 20709259
citation: MacDorman MF. Race and ethnic disparities in fetal mortality, preterm birth, and infant mortality in the United States: an overview. Semin Perinatol. 2011 Aug;35(4):200-8. doi: 10.1053/j.semperi.2011.02.017.
PMID: 21798400
citation: Pew Research Center: Internet Science & Technology. Mobile technology fact sheet. 2018; http://www.pewinternet.org/fact-sheet/mobile/. Accessed January 14, 2019, 2015.
citation: Anderson-Lewis C, Darville G, Mercado RE, Howell S, Di Maggio S. mHealth Technology Use and Implications in Historically Underserved and Minority Populations in the United States: Systematic Literature Review. JMIR Mhealth Uhealth. 2018 Jun 18;6(6):e128. doi: 10.2196/mhealth.8383.
PMID: 29914860
citation: Anoshiravani A, Gaskin G, Kopetsky E, Sandborg C, Longhurst CA. Implementing an Interoperable Personal Health Record in Pediatrics: Lessons Learned at an Academic Children's Hospital. J Particip Med. 2011 Jul 10;3:e30.
PMID: 21853160
citation: Cooper LG, Gooding JS, Gallagher J, Sternesky L, Ledsky R, Berns SD. Impact of a family-centered care initiative on NICU care, staff and families. J Perinatol. 2007 Dec;27 Suppl 2:S32-7. doi: 10.1038/sj.jp.7211840.
PMID: 18034178
citation: De Rouck S, Leys M. Information needs of parents of children admitted to a neonatal intensive care unit: a review of the literature (1990-2008). Patient Educ Couns. 2009 Aug;76(2):159-73. doi: 10.1016/j.pec.2009.01.014. Epub 2009 Mar 24.
PMID: 19321288
citation: Escobar GJ, Joffe S, Gardner MN, Armstrong MA, Folck BF, Carpenter DM. Rehospitalization in the first two weeks after discharge from the neonatal intensive care unit. Pediatrics. 1999 Jul;104(1):e2. doi: 10.1542/peds.104.1.e2.
PMID: 10390288
citation: Garfield CF, Lee YS, Kim HN, Rutsohn J, Kahn JY, Mustanski B, Mohr DC. Supporting Parents of Premature Infants Transitioning from the NICU to Home: A Pilot Randomized Control Trial of a Smartphone Application. Internet Interv. 2016 May;4(Pt 2):131-137. doi: 10.1016/j.invent.2016.05.004. Epub 2016 Jun 4.
PMID: 27990350
citation: Kim HN, Garfield C, Lee YS. Paternal and maternal information and communication technology usage as their very low birth weight infants transition home from the NICU. Int J Hum Comput Interact. 2015;31(1):44-54.
citation: Lee Y, Garfield C, Massey N, Chaysinh S, Hassan S. NICU-2-home: Supporting the transition to home from the neonatal intensive care unit using a mobile application. Conference on Human Factors in Computing Systems; May 7 - 11,
citation: Gilmore L, Cuskelly M. Factor structure of the Parenting Sense of Competence scale using a normative sample. Child Care Health Dev. 2009 Jan;35(1):48-55. doi: 10.1111/j.1365-2214.2008.00867.x. Epub 2008 Oct 22.
PMID: 18991983
responsible party type: Sponsor-Investigator
investigator affiliation: Northwestern University
investigator full name: Craig Garfield
investigator title: Professor of Pediatrics; and Attending physician and neonatal hospitalist at the Lurie Children's Hospital of Chicago where he is the Director of Research for the Division
mesh term: Premature Birth
sharing ipd: No
provided document: 