Digital Self-Management for Inflammatory Bowel Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a digital program can help people manage their inflammatory bowel disease (IBD) and improve their daily lives. The researchers aim to determine if combining this digital self-management program with standard care can positively impact how participants feel and manage their condition. Participants will receive either regular care or regular care plus access to the digital self-management program for 24 weeks. Individuals diagnosed with IBD, who experience regular symptoms, and whose quality of life is affected by the condition might be a good fit for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance IBD management and improve quality of life.
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 study team or your doctor.
What prior data suggests that this digital self-management program is safe for individuals with inflammatory bowel disease?
Research has shown that digital self-management programs for inflammatory bowel disease (IBD) are generally safe for participants. For example, a review of several digital health tools used in IBD care found that patients tolerated them well. These programs reported no major side effects, suggesting they are safe to use alongside regular treatment.
One study examined the MyGut digital health monitoring platform, which was added to IBD care without causing harm. This indicates that digital tools can safely complement traditional treatments for IBD.
Overall, existing studies suggest that digital self-management programs pose minimal risk to participants and are safe for managing IBD symptoms.12345Why are researchers excited about this trial?
Researchers are excited about the digital self-management program for inflammatory bowel disease (IBD) because it offers a novel way for patients to actively manage their condition. Unlike traditional treatments like medication or dietary changes, this program empowers patients with digital tools to track symptoms, manage stress, and adjust lifestyle choices in real-time. Additionally, integrating this program with standard care could enhance treatment outcomes by providing personalized support and fostering better patient engagement. This innovative approach has the potential to improve quality of life and long-term disease management for individuals with IBD.
What evidence suggests that this digital self-management program is effective for inflammatory bowel disease?
Research shows that digital self-management programs can help people with inflammatory bowel disease (IBD). In this trial, participants will receive either standard care or standard care plus a digital self-management program. Studies have found that these programs can improve patients' quality of life and reduce symptoms. A review of various studies found that digital health tools aid in managing IBD by promoting regular medication adherence and reducing emergency visits. Another study found that patients using digital tools felt more energetic and healthier overall. These findings suggest that digital self-management could effectively manage IBD symptoms.26789
Who Is on the Research Team?
Shirley Cohen-Mekelburg, MD, MS
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for people diagnosed with Crohn's disease or ulcerative colitis (types of inflammatory bowel disease) who currently have active symptoms and a lower quality of life due to their condition.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage in a 24-week digital self-management program to improve health outcomes for inflammatory bowel disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Digital self-management program
Trial Overview
The study compares a digital self-management program designed to help patients manage their IBD at home, versus standard medical care. Participants are randomly assigned to one of the two groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
24-week digital self-management program
Care as usual
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
Effectiveness of self-management intervention program based ...
Data are collected via self-report online questionnaires, except for disease activity and healthcare resource utilization, which are assessed by ...
Efficacy of digital health technologies in the management ...
In this umbrella review, we investigated the effectiveness of DHT in the care of patients with IBD and identified areas for future research.
Protocol for a Hybrid Effectiveness-Implementation Study
We will assess effectiveness through changes in key outcomes such as health care utilization (eg, emergency visits, hospitalizations), disease ...
Digital Therapeutic Self-Management Intervention in ... - PMC
In inflammatory bowel disease (IBD), 88% of adolescents demonstrate significant medication nonadherence, with approximately 40%–50% missed doses (4). These data ...
A New Digital Health Program for Patients With Inflammatory ...
This study aimed to perform a preliminary program evaluation, analyzing engagement and preliminary effectiveness and the effect on participants' energy levels.
Digital patient-reported outcomes in inflammatory bowel ...
This study aimed to explore hospital clinicians' attitudes towards digital patient-reported outcomes used in the routine care and treatment of inflammatory ...
A Novel Digital Self-management Intervention for Symptoms of ...
This paper aimed to describe the process of developing a supported digital self-management intervention for fatigue, pain, and urgency in IBD
Digital Health Monitoring Platforms Feasible for IBD ...
The MyGut digital health monitoring platform proves feasible and impactful during integration into inflammatory bowel disease care.
Digital Health Technologies for Remote Monitoring and ... - PMC
We performed a systematic review of digital health interventions in the management of patients with inflammatory bowel diseases (IBD) and evaluated its impact.
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