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

Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial

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 Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Behavioral: Standard Care; Behavioral: Digital self-management program

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shirley Cohen-Mekelburg, MD, MS; Phone Number: 734-845-5735; Email: shcohen@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Micigan
      • Contact: Shirley Cohen-Mekelburg, MD, MS; Phone Number: 734-845-5735; Email: shcohen@med.umich.edu
      • Principal Investigator: Shirley Cohen-Mekelburg, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care; Care as usual	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.
Experimental: Standard Care plus digital self-management program; 24-week digital self-management program	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Theoretical Framework of Acceptability (TFA)	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.	24 weeks
Treatment Acceptability Adherence Scale (TAAS)	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.	24 weeks
Qualitative interviews - self-management program group	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.	24 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Shirley Cohen-Mekelburg, MD, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Randomization; Questionnaires; Standard of care; Digital self-management program
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: HUM00246865; 1K23DK136928-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No