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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.
The investigators propose to conduct a comparative effectiveness research (CER) study of two evidence-based, patient-centered approaches implemented within an existing Specialty Medical Home (SMH) model: TEAM, an in-person, multidisciplinary team-based approach delivered at point of care and TECH, a technology-based (digital therapeutics, and telehealth) approach delivered at the patient's convenience with the guidance of health coaches. Both are designed to support care for adult patients with complex, chronic health conditions and behavioral health (BH) disorders, and will be tested in three of the nation's largest and most established SMHs for inflammatory bowel disease (IBD). IBD serves as an exemplary chronic disease model where untreated BH issues have been associated with poor medical outcomes. Primary outcomes are composite scores of measures focused on 1) IBD Symptom Severity, and 2) BH Symptom Severity. IBD Symptom Severity is measured via a composite IBD Complexity Score involving responses to two patient-reported scales: the PROMIS-GI measure and either the Harvey Bradshaw Index (for participants with Crohn's disease) or ulcerative colitis activity index (for participants with ulcerative colitis). BH Symptom Severity was measured utilizing the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS), a composite of two patient-reported scale for measuring anxiety (Generalized Anxiety Disorder scale (GAD-7) and depression (Patient Health Questionnaire depression scale (PHQ-8). Scales are further defined in Results, Outcome Measures.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Start Date
July 1, 2019
Primary Completion Date
March 28, 2025
Completion Date
March 28, 2025
Last Updated
September 3, 2025
657
ACTUAL participants
TEAM
OTHER
TECH
OTHER
Lead Sponsor
University of Pittsburgh
Collaborators
NCT06226883
NCT07207200
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07245394