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EHR-integrated rUTI Texting Platform

Sponsor
University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06035601
Collaborator
(none)
60
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: EHR-integrated texting platform
  • Other: Usual care
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An EHR-integrated Texting Platform to Promote Self-management in Women With Recurrent Urinary Tract Infections
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Sep 15, 2024
Anticipated Study Completion Date :
Sep 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Electronic health record (EHR)-integrated texting platform

Device: EHR-integrated texting platform
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
Active Comparator: Usual care

Other: Usual care
• 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)

Outcome Measures

Primary Outcome Measures

  1. Patient self-efficacy [3 months]

    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

  1. Patient satisfaction: Patient Global Impression of Improvement score [3 months]

    Patient Global Impression of Improvement score (score range 1-7 with 1 indicating very much better)

  2. Healthcare-related quality of life: EQ-5D-5L score [3 months]

    EQ-5D-5L score (score range 1-5 for each subscale with 1 indicating no problems)

  3. Healthcare-related quality of life: Recurrent UTI Impact Questionnaire score [3 months]

    Recurrent UTI Impact Questionnaire score (score range 0-10 for each subscale with 0 indicating strongly disagree)

  4. Healthcare utilization [3 months]

    Combined number of phone calls, secure messages, telehealth, and/or in-person visits per UTI episode

  5. Antibiotic prescriptions [3 months]

    Number of antibiotic prescriptions given for UTI episodes

  6. Patient medication compliance [3 months]

    Medication Adherence Self-Report Inventory score (score range 0-100 with 0 indicating no medication usage)

  7. Patient anxiety level [3 months]

    Generalized Anxiety Disorder - 7 score (score range 0-21 with 0-4 indicating minimal anxiety)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lily Arya, Professor of OBGYN, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT06035601
Other Study ID Numbers:
  • 853917
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Infections
Urinary Tract Infections

Study Results

No Results Posted as of Sep 13, 2023