Trial Outcomes & Findings for Smartphone-based Self-care Education Program for Women With Interstitial Cystitis: Educational Remote IC Aide (NCT NCT05260112)

NCT ID: NCT05260112

Last Updated: 2025-01-06

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

Score at baseline and 6 weeks

Results posted on

2025-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	52
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ERICA n=52 Participants 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. 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.
Age, Continuous	41 years n=5 Participants
Sex/Gender, Customized Sex/Gender · Female	49 Participants n=5 Participants
Sex/Gender, Customized Sex/Gender · Non-binary	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants
BMI	23.8 kg/m^2 n=5 Participants
Duration of IC/BPS symptoms in years	4 years n=5 Participants
Duration of IC/BPS diagnosis in years	2.5 years n=5 Participants
Post-menopause	9 Participants n=5 Participants
Prior treatments: Dietary modification	12 Participants n=5 Participants
Prior treatment: Pelvic floor physical therapy	26 Participants n=5 Participants
Prior treatment: Bladder analgesic	34 Participants n=5 Participants
Prior treatment: Pentosan polysulfate sodium	4 Participants n=5 Participants
Prior treatment: Tricyclic antidepressant	13 Participants n=5 Participants
Prior treatment: Antihistamine	18 Participants n=5 Participants
Prior treatment: Psychotherapy	10 Participants n=5 Participants
Prior treatment: Mindfulness practice	16 Participants n=5 Participants
Prior treatment: Yoga	13 Participants n=5 Participants
Prior treatment: Cannabinoids	12 Participants n=5 Participants
Prior treatment: Prescription opioids	3 Participants n=5 Participants
Prior treatment: Bladder instillation	4 Participants n=5 Participants
Prior treatment: Hydrodistention	5 Participants n=5 Participants
Prior treatment: Fulguration of Hunner lesions	2 Participants n=5 Participants
Concomitant conditions: anxiety disorder	35 Participants n=5 Participants
Concomitant conditions: depressive disorder	17 Participants n=5 Participants
Concomitant conditions: anorexia	4 Participants n=5 Participants
Concomitant conditions: endometriosis	8 Participants n=5 Participants
Concomitant conditions: pelvic inflammatory disease	2 Participants n=5 Participants
Concomitant conditions: vulvodynia	8 Participants n=5 Participants
Concomitant conditions: irritable bowel syndrome	13 Participants n=5 Participants
Concomitant conditions: inflammatory bowel disease	2 Participants n=5 Participants
Concomitant conditions: migraine	16 Participants n=5 Participants
Concomitant conditions: fibromyalgia	8 Participants n=5 Participants
Concomitant conditions: chronic low back pain	12 Participants n=5 Participants
Tobacco smoking	5 Participants n=5 Participants
Alcohol Use	27 Participants n=5 Participants
Provider the IC/BPS diagnosis was made by Urogynecologist	30 Participants n=5 Participants
Provider the IC/BPS diagnosis was made by Urologist	18 Participants n=5 Participants
Provider the IC/BPS diagnosis was made by Gynecologist	2 Participants n=5 Participants
Provider the IC/BPS diagnosis was made by Primary Care provider	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Score at baseline and 6 weeks

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

Outcome measures

Outcome measures
Measure	ERICA n=52 Participants 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. 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.
Change in Pain Self Efficacy Scale	10 score on a scale Interval 2.0 to 18.0

SECONDARY outcome

Timeframe: Score at baseline and 6 weeks

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

Outcome measures

Outcome measures
Measure	ERICA n=52 Participants 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. 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.
Change in Interstitial Cystitis Symptom Index	-3 score on a scale Interval -5.0 to -1.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	ERICA n=52 Participants 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. 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.
Change in Interstitial Cystitis Problem Index	-2 score on a scale Interval -5.5 to -0.5

SECONDARY outcome

Timeframe: Score at baseline and 6 weeks

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

Outcome measures

Outcome measures
Measure	ERICA n=52 Participants 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. 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.
Change in Hospital Anxiety and Depression Scale - Anxiety Subscale	-2 score on a scale Interval -3.0 to 0.0

SECONDARY outcome

Timeframe: Score at baseline and 6 weeks.

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

Outcome measures

Outcome measures
Measure	ERICA n=52 Participants 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. 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.
Change in Hospital Anxiety and Depression Scale - Depression Subscale	0 score on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	ERICA n=52 Participants 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. 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.
Change in Brief Health Care Climate Questionnaire	4 score on a scale Interval 1.0 to 9.0

Adverse Events

ERICA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lily Arya, MD

University of Pennsylvania

Phone: 267-785-8024

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place