Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammato… (NCT07456566) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease
United States40 participantsStarted 2026-06
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participant recruitment rate
Timeframe: 2 years (during the recruitment period)
2
The proportion of enrolled participants that complete the study without dropout
Timeframe: 24 weeks
3
The proportion of study assessments completed by the participant
Timeframe: 24 weeks
4
Qualitative interviews - self-management program group