Self-Management Program for Inflammatory Bowel Disease

Overseen By Kindra Clark-Snustad, DNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Live outside Washington, Recent bowel surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a self-management program for individuals with inflammatory bowel disease (IBD), a condition causing ongoing stomach pain and digestive issues. The program, called the Comprehensive Self-Management Intervention, provides online sessions on topics such as symptom tracking, relaxation, diet, and pain management. Participants will either try this new program or continue with their usual care. It suits those diagnosed with IBD who are currently experiencing symptoms and reside in Washington state. As an unphased trial, this study presents a unique opportunity to explore new methods for managing IBD symptoms and enhancing quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this self-management program is safe for people with inflammatory bowel disease?

Research has shown that the Comprehensive Self-Management (CSM) program is safe for people with irritable bowel syndrome, which shares some similarities with inflammatory bowel disease (IBD). The program includes eight sessions, online support, and weekly check-ins with a registered nurse.

Previous studies found that participants tolerated the CSM program well, with no serious side effects reported. This suggests it might also be safe for people with IBD. However, as the study is ongoing, staying updated on any new safety information is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (IBD) because it empowers patients to take control of their condition in a new way. Unlike typical treatments for IBD, which often involve medication like anti-inflammatory drugs or immunosuppressants, this intervention is delivered online and includes weekly check-ins with a registered nurse. This digital approach offers personalized support and education, aiming to improve patients' self-management skills and overall quality of life. By focusing on self-management, this program could reduce the dependency on medication and enhance long-term health outcomes for individuals with IBD.

What evidence suggests that the Comprehensive Self-Management Intervention is effective for inflammatory bowel disease?

Research has shown that a comprehensive self-management (CSM) program holds promise for individuals with similar health issues. This trial will specifically evaluate the CSM program for inflammatory bowel disease (IBD). The program has proven effective for those with irritable bowel syndrome (IBS), aiding in better symptom management. It teaches skills such as tracking symptoms and using cognitive behavioral techniques, which could also benefit people with IBD. Early studies suggest these skills can help individuals manage their condition more effectively, although more research is needed specifically for IBD. The program's success with IBS patients offers hope for its effectiveness with IBD. ^{1 2 3 4 6}

Who Is on the Research Team?

Kendra Kamp, PHD, RN

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with a healthcare provider's diagnosis of inflammatory bowel disease (IBD), including Crohn's Disease and Ulcerative Colitis, who are currently experiencing symptoms. It's not open to those living outside Washington state or anyone who has had bowel-related surgery in the past month.

Inclusion Criteria

My doctor diagnosed me with inflammatory bowel disease.

I can describe my current health symptoms.

Able to read and write in English

Exclusion Criteria

Live outside of Washington state

I have had surgery related to my bowels in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week comprehensive self-management intervention delivered online with weekly check-ins

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Self-Management Intervention

Trial Overview The study tests a Comprehensive Self-Management (CSM) program adapted from one for irritable bowel syndrome. Over eight sessions, it covers IBD education, symptom tracking, cognitive strategies, relaxation techniques, sleep improvement tips, dietary guidance, and pain management.

How Is the Trial Designed?

Group I: Usual care group Experimental Treatment 1 Intervention

The control group will receive standard care without the comprehensive self-management intervention.

Group II: Comprehensive Self-Management Experimental Treatment 1 Intervention

The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The pilot study is testing a modified comprehensive self-management intervention (CSM-IBD) for individuals with inflammatory bowel disease (IBD), aiming to improve quality of life and manage symptoms over 8 sessions within 8-12 weeks, with initial recruitment showing 4 participants enrolled as of April 2023.

The study will assess the feasibility and acceptability of the CSM-IBD program, with the goal of validating a self-management approach that is culturally appropriate and accessible, particularly for rural and underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial. Kamp, K., Clark-Snustad, K., Yoo, L., et al.[2023]

Self-management interventions for people with inflammatory bowel disease (IBD) have shown the most promise in improving outcomes related to symptoms, psychological well-being, and healthcare resource use, based on a review of 23 studies, including 13 randomized controlled trials.

While education plays a role in managing IBD, the review highlights that self-management techniques are more effective than education alone, suggesting that IBD specialist nurses could be key in facilitating these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critical review of self-management and educational interventions in inflammatory bowel disease. Barlow, C., Cooke, D., Mulligan, K., et al.[2022]

A systematic review of six studies on self-management interventions for adults with inflammatory bowel disease (IBD) found that most interventions included two of the five key self-management skills, with one intervention incorporating all five skills.

Four studies showed that self-management positively affected disease activity, while two interventions improved disease-specific health-related quality of life (HRQOL), highlighting the potential benefits of self-management strategies in managing IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Self-Management Interventions for Inflammatory Bowel Disease. Conley, S., Redeker, N.[2022]

A systematic review of nine trials involving children and adolescents with inflammatory bowel disease (IBD) found that self-management interventions showed some benefits in areas like disease activity and medication adherence, but results were inconsistent and many studies were underpowered, with most having fewer than 50 participants.

There is a need for clinical consensus on effective self-management strategies for IBD in young patients, as well as adequately powered trials to better understand how to support their self-management effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Self-Management Interventions for Children and Adolescents With Inflammatory Bowel Disease. Tran, L., Mulligan, K.[2020]

The 'flare card' self-management tool was positively received by patients with inflammatory bowel disease (IBD), helping them feel more in control of their condition and improving medication adherence and symptom management.

Over a 10-month period, patients using the 'flare card' showed a significant reduction in both IBD and non-IBD service usage, as well as decreased steroid prescriptions and unscheduled IBD care, indicating its effectiveness in optimizing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a self-management strategy in inflammatory bowel disease (IBD): patient perceptions, clinical outcomes and the impact on service. Squires, SI., Boal, AJ., Lamont, S., et al.[2020]

A comprehensive self-management program combining cognitive behavioral therapy, relaxation techniques, and dietary strategies significantly reduced gastrointestinal symptoms and improved quality of life in patients with irritable bowel syndrome (IBS) over a 13-week period.

One year after completing the program, 94% of participants continued to use at least six strategies from the program, demonstrating lasting behavioral changes and high adherence rates across all strategy categories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Self-Management Irritable Bowel Syndrome Program Produces Sustainable Changes in Behavior After 1 Year. Zia, JK., Barney, P., Cain, KC., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10285620/

Protocol for a Pilot Randomized Controlled Trial - PMC We created a modified CSM intervention tailored to individuals with IBD (CSM-IBD). The CSM-IBD is an 8-session program delivered over 8-12 weeks with check-ins ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05651542

A Comprehensive Self-Management Intervention for ... This study aims to test the feasibility, acceptability, and preliminary efficacy of a comprehensive self-management (CSM) intervention for people with ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37285195/

Protocol for a Pilot Randomized Controlled Trial - PubMed - NIH A validated comprehensive self-management (CSM) intervention is effective for patients with irritable bowel syndrome who can have symptoms ...

4. trialx.com trialx.com/clinical-trials/listings/264973/a-comprehensive-self-management-intervention-for-individuals-with-inflammatory-bowel-disease/

A Comprehensive Self-Management Intervention for ... This study aims to test the feasibility, acceptability, and preliminary efficacy of a comprehensive self-management (CSM) intervention for ...

5. formative.jmir.org formative.jmir.org/2024/1/e43286

Formative Evaluation of a Comprehensive Self-Management ... Although effective self-management interventions exist for individuals with IBS, few have been effectively implemented, and most do not consider ...

6. omicsdi.org omicsdi.org/dataset/biostudies-literature/S-EPMC10285620

S-EPMC10285620 - A Comprehensive Self-Management ... This pilot study will evaluate the feasibility and efficacy of a self-management intervention (a web-based program with weekly check-ins with a registered nurse) ...