N/A
N=657
Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions
Inflammatory Bowel Disease · Behavioral Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT03985800 ↗Enrolled (actual)
657
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: IBD Symptom Severity — 75.9; 79.9; 63.5; 65.0 Score on a scale — p=0.53
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TEAM (Other); TECH (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IBD Symptom Severity |
75.9; 79.9; 63.5; 65.0; 62.3; 64.4 | 0.53 |
| PRIMARY Behavioral Health Symptom Severity |
25.4; 26.2; 18.7; 19.7; 18.0; 19.2 | 0.90 |
| SECONDARY Functional Impairment |
37.6; 38.4; 34.2; 34.7; 33.3; 33.5 | 0.53 |
| SECONDARY IBD-IBS Symptom Severity |
222; 238; 185; 175; 174; 179 | 0.05 |
| SECONDARY Health Care Utilization |
35; 36; 292; 291; 2; 1 | 0.13 |
| SECONDARY Patient Engagement |
161; 157; 174; 178; 178; 178 | 0.37 |
| SECONDARY Quality of Life |
37.7; 35.5; 42.6; 41.4; 43.0; 43.4 | 0.06 |
Summary
A comparative effectiveness study using an individual-level randomized design along with a pragmatic, mixed-methods approach to compare two strategies (e.g. in-person supported care, technology-supported care) all of which include evidence-based components for delivering IBD and BH care. Quantitative (e.g. self-report, electronic health record, process) and qualitative (e.g., interviews) data will be collected across multiple time points during the study period.
Eligibility Criteria
Inclusion Criteria
- Inflammatory Bowel Disease Diagnosis of Crohn's or Ulcerative Colitis. Behavioral health symptoms mild to severe, defined as a score of >= 6 on the Personal Health Questionnaire 4 (PHQ4)
Exclusion Criteria
- Lack of smart phone, and/or are unable to speak, read or understand English at the minimum-required level.
Data sourced from ClinicalTrials.gov (NCT03985800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.