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

University of Pennsylvania52 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystitis, Interstitial

Interventions

ERICAOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Change in Pain Self Efficacy Scale

Validated measure of self-efficacy. Minimum 0 - Maximum 60; higher score means a better outcome

Time frame: Score at baseline and 6 weeks

Secondary Outcomes

Change in Interstitial Cystitis Symptom Index

Validated measure of IC/BPS symptom severity. Minimum 0 - Maximum 20; higher score means a worse outcome

Time frame: Score at baseline and 6 weeks

Change in Interstitial Cystitis Problem Index

Validated measure of IC/BPS symptoms' impact on quality of life. Minimum 0 - Maximum 16; higher score means a worse outcome

Time frame: Scores at baseline and 6 weeks

Change in Hospital Anxiety and Depression Scale - Anxiety Subscale

Validated measure of anxiety level. Minimum 0 - Maximum 21; higher score means a worse outcome

Time frame: Score at baseline and 6 weeks

Change in Hospital Anxiety and Depression Scale - Depression Subscale

Validated measure of depression level. Minimum 0 - Maximum 21; higher score means a worse outcome

Time frame: Score at baseline and 6 weeks.

Change in Brief Health Care Climate Questionnaire

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

Time frame: Score at baseline and 6 weeks

Data from ClinicalTrials.gov

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