Smartphone-based Self-care Education Program for Women With Interstitial Cystitis: Educational Remote IC Aide (ERICA)

April 19, 2023 updated by: Edward Kim, University of Pennsylvania

Implementation of a Text Message and Multimedia-based Program for Women Newly Diagnosed With Interstitial Cystitis/Bladder Pain Syndrome

To implement and assess clinical efficacy of a text message and multimedia-based program that (i) remotely delivers first- and second-line American Urological Association (AUA) treatments of IC/BPS; (ii) integrates treatment of biological (neuropathic pain, pelvic floor dysfunction), psychological (symptom-related fear and anxiety) and social (barriers in access to care, limited patient-provider communication) domains of IC/BPS; (iii) uses clinically validated messages to provide guidance and support.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Women over 18
  • AUA (American Urological Association) criteria for IC/BPS of "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes"
  • Interested in first- or second-line AUA treatment
  • Negative urinalysis and culture within two months of enrollment
  • English-speaking
  • Own a smartphone with text message and video viewing capability

Exclusion Criteria:

  • Women currently on third line or higher treatments
  • Currently being treated for UTI
  • History of voiding dysfunction such as urinary retention or neurogenic bladder
  • Recent (<6 months) pelvic surgery/pregnancy
  • Prior pelvic malignancy or radiation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERICA
ERICA is a smartphone-based educational program that teaches women newly diagnosed with interstitial cystitis evidence-based strategies to self-manage their symptoms at home. The program is designed to bridge the interval/gap between initial visit where they are diagnosed with interstitial cystitis and follow up visit. Participants received video learning modules via a secure and HIPAA-compliant text messaging system.
Other: ERICA

Over 6 weeks, participants receive evidence-based video learning modules twice a week via a secure and HIPAA-compliant text messaging platform. These modules include: patient education on interstitial cystitis, bladder training, trial of an elimination diet, pelvic floor physical therapy including at-home myofascial trigger point release, guided mindfulness practice, and cognitive behavioral therapy for chronic pain.

At the end of each week, participants receive a check-in message. They also have the opportunity to text questions and concerns, which will be answered using an algorithm-based, clinically validated responses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interstitial Cystitis Problem Index (ICPI)
Time Frame: Change from baseline ICPI at the completion of this 6-week program
O'Leary-Sant Interstitial Cystitis Problem Index Validated questionnaire to assess IC symptom bother.
Change from baseline ICPI at the completion of this 6-week program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

American Urogynecologic Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2021

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 844895

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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