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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
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: 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.

Recruiting Locations

University of Micigan
Ann Arbor, Michigan 48109
Contact:
Shirley Cohen-Mekelburg, MD, MS
734-845-5735
shcohen@med.umich.edu

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

Shirley Cohen-Mekelburg, MD, MS
734-845-5735
shcohen@med.umich.edu