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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a self-management program that helps people change their habits can improve health and quality of life. It is for people with active inflammatory bowel disease (IBD), which causes swelling in the digestive tract, and whose health affects their daily life.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have active IBD confirmed by medical exams, a scope exam, and tissue tests.
  • Have a disease activity score of at least 5 on the modified HBI for Crohn’s disease or at least 3 on the SCCAI for ulcerative colitis.
  • Have a stool calprotectin level above 250 micrograms per gram. This test measures signs of swelling in the bowel.
  • Have reduced quality of life from IBD, with a Short IBD Questionnaire score of 60 or less.

Who can't join

  • Cannot speak and read English.
  • Cannot regularly use the internet by phone or computer.
  • Have an ileostomy or colostomy, a surgery that brings the bowel to an opening in the belly.
  • Have an ileoanal pouch or ileorectal connection, surgeries that join the small bowel to the anus or rectum.
  • Have surgery planned soon.
  • Have short bowel syndrome, when the bowel cannot absorb enough nutrients.
  • Have a medical or mental health condition that is not under control.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MI