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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystitis, Interstitial

Intervention / Treatment
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* Other: ERICA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERICA<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial Cystitis Problem Index (ICPI) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-management, Technology, Text message, Multimedia, Pelvic floor physical therapy, Mindfulness, Cognitive behavioral therapy