Digital Self-Management Program for Inflammatory Bowel Disease

This study is testing a digital self-management program for people with Inflammatory Bowel Disease (IBD), including Ulcerative Colitis and Crohn's Disease. The program, accessed online or via mobile, aims to help you manage your condition alongside your usual medical care. Researchers want to see if this program can improve your health and quality of life. You might be able to join if you are 18 or older, have an IBD diagnosis, and are experiencing active symptoms and impaired quality of life. This study is currently recruiting about 40 participants. Success for this study means a good number of people join and complete the program, and that they find it acceptable and helpful.

Study design
This interventional study plans to enroll 40 participants. It is not specified if the study is randomized or blinded.
What's involved
You will participate in a 24-week digital self-management program and receive standard care. You will have a baseline assessment of symptoms, and complete questionnaires and visits at 8, 12, and 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study assesses participant completion and assessments up to 24 weeks.

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NCT07456566

Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease

Recruiting
NAAges 18+InterventionalTreatment
University of Michigan
~40 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Digital self-management programStandard Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participant recruitment rate
Measured over 2 years (during the recruitment period)
+3 more outcomes measured
Inflammatory Bowel Diseases
Ulcerative Colitis
Crohn Disease
1 sites across 1 states
Michigan1
  • Shirley Cohen-Mekelburg, MD, MS · PRINCIPAL_INVESTIGATOR · University of Michigan

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Eligibility criteria

Inclusion

Diagnosis of Inflammatory Bowel Disease (IBD) based on conventional clinical, endoscopic, and histopathological criteria, clinically active IBD
Impaired health-related quality of life
Clinically active IBD will be indicated by both a modified Harvey Bradshaw Index (HBI) ≥5 for Crohn's disease (CD) or a Simple Clinical Colitis Activity Index (SCCAI) ≥3 for ulcerative colitis (UC)
Fecal calprotectin \> 250 microgram (ug/g)
Impaired IBD-specific health-related quality of life will be defined as a Short IBD Questionnaire score ≤ 60

Exclusion

Unable to speak and read English
Unable to access the internet regularly by phone or web as this will impair participants ability to engage with the intervention components
Have an ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses
Are planned for imminent surgery
Have short bowel syndrome
Uncontrolled medical or psychiatric disease
  • Participant recruitment rate2 years (during the recruitment period)

    Feasibility will be defined by participant recruitment rate (the proportion of the proposed sample size who enroll to participate in the study over time). The study team hypothesize that the team will achieve a recruitment rate of 10 participants every 3 months.

  • The proportion of enrolled participants that complete the study without dropout24 weeks

    Feasibility will be defined by retention (the proportion enrolled participants who complete the study without dropout). The study team hypothesize that 70% participant retention at 24 weeks,

  • The proportion of study assessments completed by the participant24 weeks

    Feasibility willed be defined by the outcome assessment completion (the proportion of study assessments completed by participant). The study team hypothesize that 70% outcome data collection.

  • Qualitative interviews - self-management program group24 weeks

    Protocol acceptability will be determined based on post-intervention qualitative data. Discussion with participants will be facilitated by questions focusing on feedback about intervention characteristics, including content and functionality (e.g., usability, timing, frequency) and evaluate helpfulness, likes and dislikes, barriers and facilitators to use, and suggestions for improvement.