Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability

Not Applicable

• Conditions: Ulcerative Colitis (UC); Crohn Disease (CD)

• Registration Number: NCT06646757
• Lead Sponsor: University of Pennsylvania

Brief Summary

EMPOWER-IBD aims to identify behavioral interventions to strengthen patients' self-efficacy for self-management as a mechanism to reduce IBD-related disability. This multisite, randomized controlled trial with 16 arms will randomize adults with moderate-to-severe IBD-related disability to a combination of four multimodal behavioral interventions to test their clinical effectiveness in reducing IBD-related disability and improving self-efficacy. The interventions are four existing, publicly available disease-specific self-help resources offered at no cost to the participants: a book, smart app, help center, and peer mentor. Participants will complete online surveys and may engage in virtual focus groups. Participants may receive an honorarium (e-gift card) and/or be entered into a lottery for a giftcards post-survey completion and focus group participation.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-14
• Study First Submitted: 2024-08-21
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. Adults (age ≥ 18 years) with IBD and moderate-to-severe IBD-related (IBD) Disability Index score > 35 26,27)
2. Able to consent, complete surveys, and participate in focus groups in English.

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Exclusion Criteria

1. No/low disability (IBD-DI < 35) on the baseline survey
2. Inability or unwillingness to participate in the interventions
3. Inability to download apps from the Apple AppStore or Google Play store (necessary to engage with the smartapp intervention)
4. Limited English proficiency (necessary because some interventions are currently only offered in English)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in IBD-related disability based on the validated IBD-Disability Index	12 weeks	The study seeks to identify any changes in IBD-related disability pre-post intervention (week 0 and week 12) as measured by the IBD Disability Index (IBD-DI). IBD-related disability is measured by the validated 14-item IBD-disability index (yes-no responses and 1-5 point Likert scales) for limitations across 5 domains of International Classification of Functioning, Health, and Disability. Higher score indicates more disability. Total score ranges from 0-100, interpreted as 0-20 (no disability), 20-35 (mild disability), 35-50 (moderate disability), and 50-100 (severe disability).

Secondary Outcome Measures

Name	Time	Method
Change in IBD Self-efficacy as measured by the IBD Self-Efficacy Scale Wasson Health Confidence Scale	12 weeks	The study seeks to identify any changes in IBD self-efficacy as measured in the 13-item IBD-Self Efficacy Wasson Health Confidence Scale. This is one survey. A higher score indicates more confidence in self-efficacy and health confidence relative to chronic illness. Total score ranges from 0-130

Trial Locations

Locations (1)

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