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

Not Applicable

Completed

• Conditions: Cystitis, Interstitial
• Interventions: Other: ERICA

• Registration Number: NCT05260112
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-05
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-03-02
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Results First Submitted: 2023-06-05
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-15
• Last Update Submitted: 2024-11-15
• Results First Posted: 2025-01-06
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ERICA	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.

Primary Outcome Measures

Name	Time	Method
Change in Pain Self Efficacy Scale	Score at baseline and 6 weeks	Validated measure of self-efficacy. Minimum 0 - Maximum 60; higher score means a better outcome

Secondary Outcome Measures

Name	Time	Method
Change in Interstitial Cystitis Symptom Index	Score at baseline and 6 weeks	Validated measure of IC/BPS symptom severity. Minimum 0 - Maximum 20; higher score means a worse outcome
Change in Hospital Anxiety and Depression Scale - Depression Subscale	Score at baseline and 6 weeks.	Validated measure of depression level. Minimum 0 - Maximum 21; higher score means a worse outcome
Change in Brief Health Care Climate Questionnaire	Score at baseline and 6 weeks	Validated measure patient's perception of quality of and satisfaction with communication and encounter with the health care system. Minimum 6 - Maximum 30; higher score means a better outcome
Change in Interstitial Cystitis Problem Index	Scores at baseline and 6 weeks	Validated measure of IC/BPS symptoms' impact on quality of life. Minimum 0 - Maximum 16; higher score means a worse outcome
Change in Hospital Anxiety and Depression Scale - Anxiety Subscale	Score at baseline and 6 weeks	Validated measure of anxiety level. Minimum 0 - Maximum 21; higher score means a worse outcome

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States