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Clinical Trials/NCT06035601
NCT06035601
Completed
Not Applicable

An EHR-integrated Texting Platform to Promote Self-management in Women With Recurrent Urinary Tract Infections

University of Pennsylvania1 site in 1 country104 target enrollmentMarch 7, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Recurrent Urinary Tract Infection
Sponsor
University of Pennsylvania
Enrollment
104
Locations
1
Primary Endpoint
Rate of unnecessary antibiotics
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

The goal of this clinical trial is to compare a texting platform to usual care for managing recurrent urinary tract infections (UTI).

The main question it aims to answer is:

• can a texting platform that integrates symptom triage and prevention education reduce the rate of unnecessary antibiotics for recurrent UTIs as compared to usual care?

Participants enrolled onto the texting platform will:

• receive evidence-based clinical guidance for the management of symptoms of UTI and receive educational videos on how to prevent UTIs. An important secondary outcome is to determine if the texting platform improves self-efficacy for the management of recurrent UTI.

Registry
clinicaltrials.gov
Start Date
March 7, 2024
End Date
May 31, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lily Arya

Professor of OBGYN

University of Pennsylvania

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
  • Currently receiving care from a provider in Penn Urogynecology or Penn Urology
  • Exclusion criteria:
  • History of known multidrug resistant UTIs
  • History of interstitial cystitis/bladder pain syndrome or current diagnosis of chronic pelvic pain

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Rate of unnecessary antibiotics

Time Frame: 3 months

Antibiotics prescribed for patients when 1) urine culture is negative and/or urine microscopy has pyuria \< 10 WBC/HPF, 2) asymptomatic bacteriuria is present, or 3) there is no urine testing and no urinary symptoms.

Secondary Outcomes

  • Healthcare-related quality of life: Recurrent UTI Impact Questionnaire score(3 months)
  • Antibiotic prescriptions(3 months)
  • Patient self-efficacy(3 months)
  • Healthcare utilization(3 months)
  • Patient medication compliance(3 months)
  • Patient satisfaction: Patient Global Impression of Improvement score(3 months)
  • Healthcare-related quality of life: EQ-5D-5L score(3 months)

Study Sites (1)

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