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EHR-integrated rUTI Texting Platform

Primary Purpose

Recurrent Urinary Tract Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EHR-integrated texting platform
Usual care
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Urinary Tract Infection

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Females who currently meet the criteria for recurrent UTIs Age 18 years or older Owns a mobile device with text messaging capability Ability to read and write English Exclusion Criteria: Known congenital or acquired anatomical anomaly of the urinary tract system or neurogenic bladder History of interstitial cystitis/bladder pain syndrome History of chronic pelvic pain History of urinary tract malignancy with or without radiation On continuous suppressive antibiotics currently Currently pregnant or within 6 weeks of pregnancy Inadequately controlled diabetes (HbA1c > 9) On immunosuppressive or steroid medication currently Practice of chronic self-catheterization (> 1 year)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Electronic health record (EHR)-integrated texting platform

    Usual care

    Arm Description

    Outcomes

    Primary Outcome Measures

    Patient self-efficacy
    Stanford self-efficacy for managing chronic disease 6-item score (mean score range 1-10 with mean 1 indicating less self-efficacy)

    Secondary Outcome Measures

    Patient satisfaction: Patient Global Impression of Improvement score
    Patient Global Impression of Improvement score (score range 1-7 with 1 indicating very much better)
    Healthcare-related quality of life: EQ-5D-5L score
    EQ-5D-5L score (score range 1-5 for each subscale with 1 indicating no problems)
    Healthcare-related quality of life: Recurrent UTI Impact Questionnaire score
    Recurrent UTI Impact Questionnaire score (score range 0-10 for each subscale with 0 indicating strongly disagree)
    Healthcare utilization
    Combined number of phone calls, secure messages, telehealth, and/or in-person visits per UTI episode
    Antibiotic prescriptions
    Number of antibiotic prescriptions given for UTI episodes
    Patient medication compliance
    Medication Adherence Self-Report Inventory score (score range 0-100 with 0 indicating no medication usage)
    Patient anxiety level
    Generalized Anxiety Disorder - 7 score (score range 0-21 with 0-4 indicating minimal anxiety)

    Full Information

    First Posted
    September 6, 2023
    Last Updated
    October 17, 2023
    Sponsor
    University of Pennsylvania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06035601
    Brief Title
    EHR-integrated rUTI Texting Platform
    Official Title
    An EHR-integrated Texting Platform to Promote Self-management in Women With Recurrent Urinary Tract Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 16, 2023 (Anticipated)
    Primary Completion Date
    September 15, 2024 (Anticipated)
    Study Completion Date
    September 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pennsylvania

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Urinary Tract Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Electronic health record (EHR)-integrated texting platform
    Arm Type
    Experimental
    Arm Title
    Usual care
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    EHR-integrated texting platform
    Intervention 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
    Intervention Type
    Other
    Intervention Name(s)
    Usual care
    Intervention 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)
    Primary Outcome Measure Information:
    Title
    Patient self-efficacy
    Description
    Stanford self-efficacy for managing chronic disease 6-item score (mean score range 1-10 with mean 1 indicating less self-efficacy)
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Patient satisfaction: Patient Global Impression of Improvement score
    Description
    Patient Global Impression of Improvement score (score range 1-7 with 1 indicating very much better)
    Time Frame
    3 months
    Title
    Healthcare-related quality of life: EQ-5D-5L score
    Description
    EQ-5D-5L score (score range 1-5 for each subscale with 1 indicating no problems)
    Time Frame
    3 months
    Title
    Healthcare-related quality of life: Recurrent UTI Impact Questionnaire score
    Description
    Recurrent UTI Impact Questionnaire score (score range 0-10 for each subscale with 0 indicating strongly disagree)
    Time Frame
    3 months
    Title
    Healthcare utilization
    Description
    Combined number of phone calls, secure messages, telehealth, and/or in-person visits per UTI episode
    Time Frame
    3 months
    Title
    Antibiotic prescriptions
    Description
    Number of antibiotic prescriptions given for UTI episodes
    Time Frame
    3 months
    Title
    Patient medication compliance
    Description
    Medication Adherence Self-Report Inventory score (score range 0-100 with 0 indicating no medication usage)
    Time Frame
    3 months
    Title
    Patient anxiety level
    Description
    Generalized Anxiety Disorder - 7 score (score range 0-21 with 0-4 indicating minimal anxiety)
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Females who currently meet the criteria for recurrent UTIs Age 18 years or older Owns a mobile device with text messaging capability Ability to read and write English Exclusion Criteria: Known congenital or acquired anatomical anomaly of the urinary tract system or neurogenic bladder History of interstitial cystitis/bladder pain syndrome History of chronic pelvic pain History of urinary tract malignancy with or without radiation On continuous suppressive antibiotics currently Currently pregnant or within 6 weeks of pregnancy Inadequately controlled diabetes (HbA1c > 9) On immunosuppressive or steroid medication currently Practice of chronic self-catheterization (> 1 year)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Surbhi Agrawal, MD
    Phone
    2676244438
    Email
    surbhi.agrawal@pennmedicine.upenn.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lily Arya, MD, MS
    Email
    larya@pennmedicine.upenn.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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