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

NCT07456566 | Not Yet Recruiting

• 2 other identifiers: HUM002468651K23DK136928-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Keywords

Digital self-management program; Standard of care; Randomization; Questionnaires

Outcome Measures

Primary Outcomes (4)

• Participant recruitment rate

  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.

  2 years (during the recruitment period)

• The proportion of enrolled participants that complete the study without dropout

  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,

  24 weeks

• The proportion of study assessments completed by the participant

  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.

  24 weeks

• Qualitative interviews - self-management program group

  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.

  24 weeks

Secondary Outcomes (3)

• Theoretical Framework of Acceptability (TFA)

  24 weeks

• Treatment Acceptability Adherence Scale (TAAS)

  24 weeks

• Qualitative interviews - self-management program group

  24 weeks

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Care as usual

Behavioral: Standard Care

Standard Care plus digital self-management program

EXPERIMENTAL

24-week digital self-management program

Behavioral: Digital self-management program; Behavioral: Standard Care

Interventions

Digital self-management program BEHAVIORAL

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.

Standard Care plus digital self-management program

Standard Care BEHAVIORAL

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.

Standard Care plus digital self-management program; Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Micigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Shirley Cohen-Mekelburg, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley Cohen-Mekelburg, MD, MS

CONTACT

734-845-5735; shcohen@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It will be difficult to effectively blind the participants and research staff to the intervention, but the study team will avoid unnecessary inquiry about allocation or hypothesized outcomes with participants and clinicians.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)