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

Official title

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

Overview

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

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 s
• 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.

Primary outcome measures

• Participant recruitment rate [Time frame: 2 years (during the recruitment period)]
• The proportion of enrolled participants that complete the study without dropout [Time frame: 24 weeks]
• The proportion of study assessments completed by the participant [Time frame: 24 weeks]
• Qualitative interviews - self-management program group [Time frame: 24 weeks]

Secondary outcome measures (3)

• Theoretical Framework of Acceptability (TFA) [Time frame: 24 weeks]
• Treatment Acceptability Adherence Scale (TAAS) [Time frame: 24 weeks]
• Qualitative interviews - self-management program group [Time frame: 24 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Micigan — Ann Arbor

Identifiers

NCT: NCT07456566 · HUM00246865 · 1K23DK136928-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗