Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 803
- 试验地点
- 2
- 主要终点
- Change in IBD-related disability based on the validated IBD-Disability Index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age ≥ 18 years) with IBD and moderate-to-severe IBD-related (IBD) Disability Index score > 35 26,27)
- •Able to consent, complete surveys, and participate in focus groups in English.
排除标准
- •No/low disability (IBD-DI < 35) on the baseline survey
- •Inability or unwillingness to participate in the interventions
- •Inability to download apps from the Apple AppStore or Google Play store (necessary to engage with the smartapp intervention)
- •Limited English proficiency (necessary because some interventions are currently only offered in English)
研究组 & 干预措施
Arm 1
No resource provision
Arm 2
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: PEER (Behavioral)
Arm 3
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
干预措施: HELP (Behavioral)
Arm 4
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: HELP (Behavioral)
Arm 4
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: PEER (Behavioral)
Arm 5
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
干预措施: CBT (Behavioral)
Arm 6
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: CBT (Behavioral)
Arm 6
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: PEER (Behavioral)
Arm 7
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
干预措施: CBT (Behavioral)
Arm 7
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
干预措施: HELP (Behavioral)
Arm 8
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: CBT (Behavioral)
Arm 8
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: HELP (Behavioral)
Arm 8
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: PEER (Behavioral)
Arm 10
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: PEER (Behavioral)
Arm 11
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
干预措施: HELP (Behavioral)
Arm 12
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: HELP (Behavioral)
Arm 12
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: PEER (Behavioral)
Arm 13
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
干预措施: CBT (Behavioral)
Arm 14
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: CBT (Behavioral)
Arm 14
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: PEER (Behavioral)
Arm 13
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
干预措施: APP (Behavioral)
Arm 15
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
干预措施: CBT (Behavioral)
Arm 15
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
干预措施: HELP (Behavioral)
Arm 16
- My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
- "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
- IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
- Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: PEER (Behavioral)
Arm 16
- My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
- "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
- IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
- Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: CBT (Behavioral)
Arm 16
- My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
- "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
- IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
- Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: HELP (Behavioral)
Arm 10
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: APP (Behavioral)
Arm 14
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: APP (Behavioral)
Arm 12
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: APP (Behavioral)
Arm 16
- My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
- "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
- IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
- Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation
干预措施: APP (Behavioral)
Arm 15
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
"Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
干预措施: APP (Behavioral)
Arm 11
My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
干预措施: APP (Behavioral)
Arm 9
1) My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
干预措施: APP (Behavioral)
结局指标
主要结局
Change in IBD-related disability based on the validated IBD-Disability Index
时间窗: 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).
次要结局
- Change in IBD self-efficacy as measured by the IBD Self-Efficacy Scale Wasson Health Confidence Scale(12 weeks)