xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06035601</url>
    </required_header>
    <id_info>
      <org_study_id>853917</org_study_id>
      <nct_id>NCT06035601</nct_id>
    </id_info>
    <brief_title>EHR-integrated rUTI Texting Platform</brief_title>
    <official_title>An EHR-integrated Texting Platform to Promote Self-management in Women With Recurrent Urinary Tract Infections</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pennsylvania</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Pennsylvania</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare a texting platform to usual care for recurrent&#xD;
        urinary tract infection (UTI) disease management.&#xD;
  &#xD;
        The main question it aims to answer is:&#xD;
  &#xD;
        • can a texting platform that integrates symptom triage and prevention education improve&#xD;
        patients' sense of self-efficacy in managing recurrent UTIs as compared to usual care?&#xD;
  &#xD;
        Participants enrolled onto the texting platform will:&#xD;
  &#xD;
          -  receive evidence-based clinical guidance for the management of acute symptoms of UTI and&#xD;
  &#xD;
          -  receive regular prevention education.&#xD;
  &#xD;
        Researchers will compare the texting platform to usual care to see if there is any difference&#xD;
        in patients' self-efficacy scores post-intervention.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient self-efficacy</measure>
      <time_frame>3 months</time_frame>
      <description>Stanford self-efficacy for managing chronic disease 6-item score (mean score range 1-10 with mean 1 indicating less self-efficacy)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction: Patient Global Impression of Improvement score</measure>
      <time_frame>3 months</time_frame>
      <description>Patient Global Impression of Improvement score (score range 1-7 with 1 indicating very much better)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare-related quality of life: EQ-5D-5L score</measure>
      <time_frame>3 months</time_frame>
      <description>EQ-5D-5L score (score range 1-5 for each subscale with 1 indicating no problems)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare-related quality of life: Recurrent UTI Impact Questionnaire score</measure>
      <time_frame>3 months</time_frame>
      <description>Recurrent UTI Impact Questionnaire score (score range 0-10 for each subscale with 0 indicating strongly disagree)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare utilization</measure>
      <time_frame>3 months</time_frame>
      <description>Combined number of phone calls, secure messages, telehealth, and/or in-person visits per UTI episode</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Antibiotic prescriptions</measure>
      <time_frame>3 months</time_frame>
      <description>Number of antibiotic prescriptions given for UTI episodes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient medication compliance</measure>
      <time_frame>3 months</time_frame>
      <description>Medication Adherence Self-Report Inventory score (score range 0-100 with 0 indicating no medication usage)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient anxiety level</measure>
      <time_frame>3 months</time_frame>
      <description>Generalized Anxiety Disorder - 7 score (score range 0-21 with 0-4 indicating minimal anxiety)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Recurrent Urinary Tract Infection</condition>
    <arm_group>
      <arm_group_label>Electronic health record (EHR)-integrated texting platform</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>EHR-integrated texting platform</intervention_name>
      <description>An evidence-based algorithm that provides symptom triage and clinical guidance during an episode of acute UTI&#xD;
  Evidence-based prevention education material on recurrent UTIs&#xD;
  5 standing orders for urinalysis and urine culture in the EHR upon enrollment&#xD;
  Standard-of-care management for recurrent UTI</description>
      <arm_group_label>Electronic health record (EHR)-integrated texting platform</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Usual care</intervention_name>
      <description>• Standard-of-care management of recurrent UTI (phone calls and/or secure EHR messages for acute symptoms, and 3 to 6 month in-person visits for check-ins and prevention treatment discussion)</description>
      <arm_group_label>Usual care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provision of signed and dated informed consent form&#xD;
  &#xD;
            -  Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study&#xD;
  &#xD;
            -  Females who currently meet the criteria for recurrent UTIs&#xD;
  &#xD;
            -  Age 18 years or older&#xD;
  &#xD;
            -  Owns a mobile device with text messaging capability&#xD;
  &#xD;
            -  Ability to read and write English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known congenital or acquired anatomical anomaly of the urinary tract system or&#xD;
               neurogenic bladder&#xD;
  &#xD;
            -  History of interstitial cystitis/bladder pain syndrome&#xD;
  &#xD;
            -  History of chronic pelvic pain&#xD;
  &#xD;
            -  History of urinary tract malignancy with or without radiation&#xD;
  &#xD;
            -  On continuous suppressive antibiotics currently&#xD;
  &#xD;
            -  Currently pregnant or within 6 weeks of pregnancy&#xD;
  &#xD;
            -  Inadequately controlled diabetes (HbA1c &gt; 9)&#xD;
  &#xD;
            -  On immunosuppressive or steroid medication currently&#xD;
  &#xD;
            -  Practice of chronic self-catheterization (&gt; 1 year)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Surbhi Agrawal, MD</last_name>
      <phone>2676244438</phone>
      <email>surbhi.agrawal@pennmedicine.upenn.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lily Arya, MD, MS</last_name>
      <email>larya@pennmedicine.upenn.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
      <investigator_full_name>Lily Arya</investigator_full_name>
      <investigator_title>Professor of OBGYN</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Urinary Tract Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06035601
  org study id: 853917
  nct id: NCT06035601
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to compare a texting platform to usual care for recurrent
        urinary tract infection (UTI) disease management.
  
        The main question it aims to answer is:
  
        • can a texting platform that integrates symptom triage and prevention education improve
        patients' sense of self-efficacy in managing recurrent UTIs as compared to usual care?
  
        Participants enrolled onto the texting platform will:
  
          -  receive evidence-based clinical guidance for the management of acute symptoms of UTI and
  
          -  receive regular prevention education.
  
        Researchers will compare the texting platform to usual care to see if there is any difference
        in patients' self-efficacy scores post-intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Patient self-efficacy
  time frame: 3 months
  description: Stanford self-efficacy for managing chronic disease 6-item score (mean score range 1-10 with mean 1 indicating less self-efficacy)
  measure: Patient satisfaction: Patient Global Impression of Improvement score
  time frame: 3 months
  description: Patient Global Impression of Improvement score (score range 1-7 with 1 indicating very much better)
  measure: Healthcare-related quality of life: EQ-5D-5L score
  time frame: 3 months
  description: EQ-5D-5L score (score range 1-5 for each subscale with 1 indicating no problems)
  measure: Healthcare-related quality of life: Recurrent UTI Impact Questionnaire score
  time frame: 3 months
  description: Recurrent UTI Impact Questionnaire score (score range 0-10 for each subscale with 0 indicating strongly disagree)
  measure: Healthcare utilization
  time frame: 3 months
  description: Combined number of phone calls, secure messages, telehealth, and/or in-person visits per UTI episode
  measure: Antibiotic prescriptions
  time frame: 3 months
  description: Number of antibiotic prescriptions given for UTI episodes
  measure: Patient medication compliance
  time frame: 3 months
  description: Medication Adherence Self-Report Inventory score (score range 0-100 with 0 indicating no medication usage)
  measure: Patient anxiety level
  time frame: 3 months
  description: Generalized Anxiety Disorder - 7 score (score range 0-21 with 0-4 indicating minimal anxiety)
  arm group label: Electronic health record (EHR)-integrated texting platform
  arm group type: Experimental
  arm group label: Usual care
  arm group type: Active Comparator
  intervention type: Device
  intervention name: EHR-integrated texting platform
  description: An evidence-based algorithm that provides symptom triage and clinical guidance during an episode of acute UTI
  Evidence-based prevention education material on recurrent UTIs
  5 standing orders for urinalysis and urine culture in the EHR upon enrollment
  Standard-of-care management for recurrent UTI
  arm group label: Electronic health record (EHR)-integrated texting platform
  intervention type: Other
  intervention name: Usual care
  description: • Standard-of-care management of recurrent UTI (phone calls and/or secure EHR messages for acute symptoms, and 3 to 6 month in-person visits for check-ins and prevention treatment discussion)
  arm group label: Usual care
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Surbhi Agrawal, MD
  phone: 2676244438
  email: surbhi.agrawal@pennmedicine.upenn.edu
  last name: Lily Arya, MD, MS
  email: larya@pennmedicine.upenn.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Pennsylvania
  investigator full name: Lily Arya
  investigator title: Professor of OBGYN
  mesh term: Infections
  mesh term: Urinary Tract Infections
  sharing ipd: No