Crohn Disease · Inflammatory Bowel Diseases · Ulcerative Colitis
Digital Self-Management Program for Adults With Inflammatory Bowel Disease
This randomized pilot trial is studying the feasibility and acceptability of adding a 24-week digital self-management program to standard care for adults with clinically active inflammatory bowel disease and impaired health-related quality of life.
Registry title: Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- Digital self-management program or Standard Care
- Design
- Randomized
- Central study contact
- Shirley Cohen-Mekelburg, MD, MS734-845-5735shcohen@med.umich.edu
- Sponsor
- University of Michigan
Research question
Is it feasible and acceptable to add a 24-week digital self-management program to standard care for adults with active inflammatory bowel disease, and what role might the program have in health and health-related quality of life?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older with inflammatory bowel disease, including Crohn disease or ulcerative colitis.
- The study is looking for people whose inflammatory bowel disease is clinically active according to specified symptom-index thresholds.
- The study is looking for people with fecal calprotectin above 250 micrograms per gram and impaired inflammatory bowel disease-specific quality of life.
- Participants must be able to speak and read English and regularly access the internet by phone or web.
- The listed recruiting location is in Ann Arbor, Michigan.
Participation overview
What participation may involve
Participants receive standard care and complete assessments over 24 weeks. Those assigned to the experimental group also receive access to the digital self-management program. What participation may involve: - Complete baseline self-reported and clinician assessments of symptoms. - Allow review of the electronic health record for standard-care inflammatory biomarker measurements. - Complete questionnaires and follow-up activities at weeks 8, 12, and 24. - Participants assigned to the digital-program group may use web or mobile modules supporting symptom and disease self-management. - The digital-program group completes a clinician assessment at week 12 and a final remote visit or video meeting after 24 weeks. - Participants in the digital-program group may take part in a post-intervention qualitative interview about usability, helpfulness, barriers, and suggestions for improvement. Reported participant follow-up and the digital self-management program extend through 24 weeks. The registry reports a baseline assessment and follow-ups at weeks 8, 12, and 24. The digital-program description says the final 24-week activity is a remote visit or video meeting.
Study interventions
What participants may receive or do
- Digital self-management program: Participants assigned to this group may access a 24-week program through the web or a mobile device. Its modules are intended to support symptom and disease management and the development of longer-term self-management habits and skills. The program is provided in addition to standard care, and the registry states that participants may stop using it without penalty to standard inpatient treatment.
- Standard Care: Standard care is provided in both study groups. Reported study activities include a baseline symptom assessment, clinician assessment, electronic health record review for standard-care inflammatory biomarker measurements, questionnaires, and follow-ups at weeks 8, 12, and 24.
Study design
How the comparison works
This is an interventional, randomized, parallel-group pilot trial with an estimated enrollment of 40 participants. It compares standard care with standard care plus a digital self-management program. Participants are randomly assigned to one of two parallel groups. The trial is not blinded. The registry explains that participants and research staff are difficult to blind to the intervention, although the team plans to avoid unnecessary discussion of assignment or hypothesized outcomes with participants and clinicians. The active comparison group receives care as usual. Standard care is also provided to the group using the digital program. No placebo or sham group is listed; the comparison is between standard care alone and standard care plus the digital program.
Reported activities
Procedures and tests
- Baseline self-reported symptom assessment
- Baseline clinician assessment of symptoms
- Electronic health record review for standard-care inflammatory biomarker measurements
- Follow-up self-report questionnaires at weeks 8 and 12 for the digital-program group
- Questionnaires and follow-up visits at weeks 8, 12, and 24 as part of the standard-care intervention description
- Clinician assessment at week 12 for the digital-program group
- Final remote visit or video meeting after 24 weeks for the digital-program group
- Post-intervention qualitative interview for the digital-program group
- A 19-item Theoretical Framework of Acceptability questionnaire at 24 weeks
- A 10-item Treatment Acceptability Adherence Scale at 24 weeks
- Screening may involve confirming symptom-index scores, fecal calprotectin, and inflammatory bowel disease-specific quality-of-life score requirements.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- A diagnosis of inflammatory bowel disease must be based on conventional clinical, endoscopic, and tissue-examination criteria, and the disease must be clinically active.
- The person must have impaired health-related quality of life.
- Clinical activity must be shown by a modified Harvey Bradshaw Index of at least 5 for Crohn disease or a Simple Clinical Colitis Activity Index of at least 3 for ulcerative colitis.
- Fecal calprotectin must be above 250 micrograms per gram.
- The Short Inflammatory Bowel Disease Questionnaire score must be 60 or lower.
Possible reasons someone may not be able to join
- People unable to speak and read English are excluded.
- People without regular internet access by phone or web are excluded because the intervention uses digital components.
- People with an ileostomy, colostomy, ileoanal pouch, or ileorectal anastomosis are excluded.
- People with imminent surgery planned are excluded.
- People with short bowel syndrome are excluded.
- People with uncontrolled medical or psychiatric disease are excluded.
Important unknowns
What the record does not make clear
- Both groups receive standard care, but the registry does not describe which inflammatory bowel disease treatments may continue or whether treatment changes are allowed during the trial.
- The record does not report medication washout or stability requirements.
- The record does not explain how worsening inflammatory bowel disease would be treated during the study.
- Eligibility refers to a diagnosis based partly on endoscopic criteria, but the record does not state whether a new endoscopy is required for screening or follow-up.
- The program is available by web or mobile device and the final activity may be remote, but the record does not state which other assessments require attendance in Ann Arbor.
- The record does not state which research or standard-care costs are covered or billed to insurance.
- The record does not report whether participants are compensated.
- The record does not report reimbursement or support for travel.
- The record does not state whether participants can continue accessing the digital self-management program after 24 weeks.
Before contacting the site
Questions for the study team
- Which current inflammatory bowel disease medicines may continue, and must treatment doses remain stable?
- Which assessments require an in-person visit in Ann Arbor, and which can be completed remotely?
- Will screening or follow-up require a new endoscopy, stool test, blood test, or other sample?
- What happens if inflammatory bowel disease symptoms worsen or surgery becomes necessary during the study?
- Which costs are covered, could anything be billed to insurance, and is compensation or travel support available?
- How much time do the questionnaires, digital modules, clinician assessments, and qualitative interview usually require?
- Can participants keep access to the digital self-management program after the 24-week study period?
Before changing care
Questions for your gastroenterologist
- Would joining a study that continues standard care require any changes to my current medicines or monitoring?
- How clinically active and stable is my inflammatory bowel disease, and how do my recent symptom scores and fecal calprotectin compare with the study criteria?
- What approved treatment or self-management alternatives should I consider alongside or instead of contacting this study?
- What clinical concerns should I discuss with the research team if my symptoms worsen or surgery becomes necessary?
- How should my gastroenterology team and the research team coordinate laboratory results, symptom assessments, treatment changes, and urgent care?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for inflammatory bowel disease. This research will increase the understanding of the role of a self-management program in improving health and health-related quality of life for patients with inflammatory bowel disease. The study team hypothesizes: * the study will achieve a recruitment rate of 10 participants every 3 months * 70% participant retention at 24 weeks * 70% outcome data collection * 70% intervention completion * high acceptability
Study design and administration
- Organization
- University of Michigan
- Organization class
- Other
- Organization study ID
- HUM00246865
- Lead sponsor
- University of Michigan
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Active Comparator
Standard care
Care as usual
Interventions: Behavioral: Standard Care
Experimental
Standard Care plus digital self-management program
24-week digital self-management program
Interventions: Behavioral: Digital self-management program, Behavioral: Standard Care
Interventions
Behavioral
Digital self-management program
Participants will receive this 24-week digital self-management program that was developed for patients with inflammatory bowel disease in addition to standard care. The program will be accessed through the web or a mobile device and will include different modules that will help support in managing participant's symptoms and disease both in the short-term as well as helping to build habits and skills to support participants in managing disease long-term. Participants are not required to use the self-management program and may stop using it at any time without any penalty to standard inpatient treatment. Additionally, participants will be asked to complete a follow-up self-report questionnaire at week 8 and week 12, and a clinician assessment at week 12. After 24 weeks a final remote visit or video meeting will be completed.
Behavioral
Standard Care
Participants will have baseline assessment of symptoms both based on self-report and a clinician's assessment, and review the electronic health record for standard of care inflammatory biomarker measurements. In addition, questionnaires will be collected and visit completed at 8,12, and 24-week follow-ups.
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (5)
- Diagnosis of Inflammatory Bowel Disease (IBD) based on conventional clinical, endoscopic, and histopathological criteria, clinically active IBDRegistry-derived · unreviewed
- Impaired health-related quality of lifeRegistry-derived · unreviewed
- 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)Registry-derived · unreviewed
- Fecal calprotectin \> 250 microgram (ug/g)Registry-derived · unreviewed
- Impaired IBD-specific health-related quality of life will be defined as a Short IBD Questionnaire score ≤ 60Registry-derived · unreviewed
Exclusion criteria (6)
- Unable to speak and read EnglishRegistry-derived · unreviewed
- Unable to access the internet regularly by phone or web as this will impair participants ability to engage with the intervention componentsRegistry-derived · unreviewed
- Have an ileostomy, colostomy, ileoanal pouch, or ileorectal anastomosesRegistry-derived · unreviewed
- Are planned for imminent surgeryRegistry-derived · unreviewed
- Have short bowel syndromeRegistry-derived · unreviewed
- Uncontrolled medical or psychiatric diseaseRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Participant recruitment rate
Time frame: 2 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.
Primary outcome
The proportion of enrolled participants that complete the study without dropout
Time frame: 24 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,
Primary outcome
The proportion of study assessments completed by the participant
Time frame: 24 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.
Primary outcome
Qualitative interviews - self-management program group
Time frame: 24 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.
Secondary outcome
Theoretical Framework of Acceptability (TFA)
Time frame: 24 weeks
Intervention acceptability will be measured using a 19-item Likert scale questionnaire developed from Sekhon's Theoretical Framework of Acceptability (TFA).TFA is organized into seven domains that are important to assess the acceptability of healthcare interventions from the perspective of those receiving the intervention (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, self-efficacy). The 19-item questionnaire uses a 5-point Likert scale, where responses ranged from 5 (strongly agree) to 1 (strongly disagree). Scores range from 19-95 with higher scores representing higher acceptability.
Secondary outcome
Treatment Acceptability Adherence Scale (TAAS)
Time frame: 24 weeks
The 10-item TAAS was developed to assess both the acceptability of psychological interventions and anticipated adherence. The TAAS uses a 7-point Likert scale (1 = disagree strongly to 7 = agree strongly) for each item. Total scores range from 10 to 70, with higher scores indicating greater acceptability and anticipated adherence.
Secondary outcome
Qualitative interviews - self-management program group
Time frame: 24 weeks
Intervention 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.
Recruiting locations in the United States
University of Micigan
RecruitingAnn Arbor, Michigan, 48109, United States
Shirley Cohen-Mekelburg, MD, MS734-845-5735shcohen@med.umich.edu
Shirley Cohen-Mekelburg, MD, MS
Central study contacts
Registry dates
- First posted
- Mar 6, 2026
- Primary completion
- Mar 2028
- Overall completion
- Mar 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.