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Specialty Medical Homes for IBD and Behavioral Health Conditions

N/A

Waitlist Available

Led By Eva Szigethy, MD, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Behavioral health symptoms mild to severe, defined as a score of >= 6 on the Personal Health Questionnaire 4 (PHQ4)

Inflammatory Bowel Disease Diagnosis of Crohn's or Ulcerative Colitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up compare at baseline, 6-month and 12-month for any changes

Awards & highlights

Study Summary

This trial will compare two care strategies for people with IBD and BH, including in-person and technology-supported care. Data will be collected over time through self-report, interviews, and electronic health records.

Who is the study for?

This trial is for individuals with Inflammatory Bowel Disease (IBD), such as Crohn's or Ulcerative Colitis, who also have mild to severe behavioral health symptoms. Participants must score at least a 6 on the PHQ4 questionnaire. People without a smartphone or those unable to speak, read, or understand English well enough are not eligible.Check my eligibility

What is being tested?

The study compares two strategies for managing IBD and behavioral health: in-person supported care versus technology-supported care. It uses a randomized design and collects both quantitative data (like self-reports) and qualitative data (such as interviews).See study design

What are the potential side effects?

Since this trial focuses on care strategies rather than medications, it does not list specific side effects like drug trials do. However, participants may experience stress or discomfort related to the interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have mild to severe behavioral health symptoms.

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I have been diagnosed with Crohn's disease or Ulcerative Colitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ compare at baseline, 6-month and 12-month for any changes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~compare at baseline, 6-month and 12-month for any changes

This trial's timeline: 3 weeks for screening, Varies for treatment, and compare at baseline, 6-month and 12-month for any changes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Behavioral Health Symptom Severity

Inflammatory Bowel Disease Symptom Severity

Inflammatory Bowel Disease Symptom Severity-HBI

+1 more

Secondary outcome measures

Functional Impairment

Health Care Utilization

Inflammatory Bowel Diseases

+1 more

Trial Design

2Treatment groups

Active Control

Group I: TEAM-care as usual approachActive Control1 Intervention

Patients will be triaged based on their physical health (PH) and behavioral health (BH) complexity to determine the frequency of in-person visits and how much of these visits will be devoted to medical versus BH issues

Group II: TECH-telehealth approachActive Control1 Intervention

Each patient will have an initial face-to-face visit with the core treatment team described above and undergo the same triage process to determine their PH/BH care needs. Each TECH patient will participate in one face-to-face treatment team visit per year unless more frequent visits are deemed to be medically necessary; however, all other interactions will be conducted via technology-supported modalities

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,719 Previous Clinical Trials

16,341,683 Total Patients Enrolled

Mount Sinai Hospital, New YorkOTHER

33 Previous Clinical Trials

890,140 Total Patients Enrolled

The Cleveland ClinicOTHER

1,026 Previous Clinical Trials

1,365,418 Total Patients Enrolled

Media Library

TEAM Clinical Trial Eligibility Overview. Trial Name: NCT03985800 — N/A

Inflammatory Bowel Disease Research Study Groups: TEAM-care as usual approach, TECH-telehealth approach

Inflammatory Bowel Disease Clinical Trial 2023: TEAM Highlights & Side Effects. Trial Name: NCT03985800 — N/A

TEAM 2023 Treatment Timeline for Medical Study. Trial Name: NCT03985800 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to participate in this clinical research?

"This trial is open to 990 people who are between 18 and 60 years old, have a diagnosis of either Crohn's or Ulcerative colitis, and present mild-to-severe behavioural health symptoms (as indicated by a score of 6+ on the Personal Health Questionnaire 4)."

Answered by AI

Are there any available slots within this investigation for participants?

"Clinicaltrials.gov has confirmed that this medical experiment is actively acquiring patients, with the initial posting having taken place on July 1st 2019 and the most recent update happening September 7th 2022."

Answered by AI

How many participants is the clinical trial recruiting?

"Affirmative. According to clinicaltrials.gov, this medical study is actively enlisting participants with a first posting date of July 1st 2019 and most recent update on September 7th 2022. There are 990 patients that need to be recruited at one research centre."

Answered by AI

What are the intended results from this clinical investigation?

"The primary aim of this study, to be measured at the onset and after half-yearly intervals for up to a year, is evaluating changes in Inflammatory Bowel Disease Symptom Severity. Secondary objectives encompass Health Care Utilization (as assessed by composite scores from Emergency Department visits, unplanned hospitalizations etc.), Functional Impairment (assessed through SF12V2), and Self-Efficacy (measured using the Inflammatory Bowel Disease Self-Efficacy Scale)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions

Eva Szigethy 2019. "Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03985800.

All > Inflammatory Bowel Disease > Ibd