NCT07210580 · VA Office of Research and Development
Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease
(MBC-IBD)
What this study is about
This research study is addressing issues related to Inflammatory bowel disease (IBD), which is a chronic autoimmune disorder that affects over 60,000 Veterans. With close monitoring and timely treatment adjustment, the investigators can stop the natural progression of IBD, improving health-related quality of life (HRQOL) and reducing flares and hospitalizations.
View original scientific description
This research study is addressing issues related to Inflammatory bowel disease (IBD), which is a chronic autoimmune disorder that affects over 60,000 Veterans. With close monitoring and timely treatment adjustment, the investigators can stop the natural progression of IBD, improving health-related quality of life (HRQOL) and reducing flares and hospitalizations. However, it is difficult to closely monitor Veterans with IBD between clinic visits. There is a critical need for solutions that support close between visit monitoring of Veterans with IBD. The Measurement-Based Care (MBC) for IBD study will take a systematic approach to collect, share, and act on patient reported outcome (PRO) data that can be used to achieve close monitoring. MBC supports patients' in managing their condition and boosting their confidence in their ability to handle their symptoms and disease, and also supports care teams in early recognition of health issues. The investigators will work with both Veterans and their care teams to understand and assess this program so it can be a model for future initiatives.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- receiving IBD care at one of the four sites
- reporting an impaired IBD-specific HRQOL using the Short IBD Questionnaire (SIBDQ\<60, as used by others)
- willingness and ability to participate in study procedures Clinic staff criteria:
- relevant clinic staff (gastroenterologists, advanced practice providers, nurses) involved in MBC in IBD at the four study sites (Ann Arbor, Atlanta, Houston, Portland).
Exclusion criteria
- Veteran Patient Exclusion criteria:
- Presence of an ostomy or ileal-pouch anal anastomosis
- Severe comorbid medical condition that can confound PRO scores and treatment priorities (e.g., cancer, transplant).
- Clinic staff without any experience with MBC in IBD.
Where
- Decatur, Georgia
- Ann Arbor, Michigan
- Portland, Oregon
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations