Inflammatory Bowel DiseaseNCT03985800
Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions
A study testing TEAM and TECH in people with Inflammatory Bowel Disease and Behavioral Symptoms, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inflammatory Bowel Disease, Behavioral Symptoms
- What is being tested?
- TEAM and TECH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 657 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Lack of smart phone, and/or are unable to speak, read or understand English at the minimum-required level.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
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.
- Conditions
- Inflammatory Bowel Disease, Behavioral Symptoms
- Being tested
- TEAM, TECH
- Medical subject headings
- Inflammatory Bowel Diseases, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEAMOther
TEAM incorporates team-based care with traditional in-person clinic visits. The care team includes a gastroenterologist, nurse practitioner, nutritionist, social worker/behavioral health specialist, and a psychologist or psychiatrist.
TECHOther
TECH uses team-based care similar to TEAM, but in-person care is substituted with telemedicine (i.e., video visits and consultations) and digital behavioral health tools.
| Study group | Role | What they receive |
|---|---|---|
| TEAM-care as usual approach | Active comparator | 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. Minor modifications were made to the TEAM approach during the COVID-19 public health emergency to account for reduced face-to-face time without changing the underlying differentiation between the two models of delivering SMH care. Receives: Other: TEAM |
| TECH-telehealth approach | Active comparator | 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 Receives: Other: TECH |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBD Symptom Severity
IBD symptom severity was measured via a composite IBD Complexity Score developed by clinical researchers to quantify both biological and psychosocial domains of IBD within an SMH setting. It includes the sum of patient-reported responses to two scales: the PROMIS GI symptoms scale, evaluating four domains of gastrointestinal symptoms; and disease-specific PRO-2 disease severity indices taken from the Harvey Bradshaw Index (for individuals with Crohn's disease) and Ulcerative Colitis Activity Index (for individuals with ulcerative colitis). The complexity score is calculated by adding the value of the patient's PRO-2 to the cumulative PROMIS-GI score. Lower scores indicate lower symptom severity; higher scores indicate higher symptom severity. The minimum score is 0; the maximum score is open-ended based on patient response. Only the total IBD Complexity Score is reported.
Measured: Compare scores at Baseline, 6-month and 12-month for any changes
Behavioral Health Symptom Severity
Behavioral health symptom severity was measured utilizing the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) - which combines the PHQ-8 and GAD-7 scales - as a composite measure of depression and anxiety. The Patient Health Questionnaire 8-item depression scale (PHQ-8) and 7-item Generalized Anxiety Disorder scale (GAD-7) are among the best validated and most commonly used depression and anxiety measures, respectively. The PHQ-ADS is the sum of the PHQ-8 and GAD-7, where a decrease in scores indicates a decrease in BH symptom severity; a decrease of 3-4 points indicates MCID. Lower scores indicate lower levels of behavioral health symptom severity; higher scores indicate higher symptom severity. The minimum score is 0; the maximum score is 45. Only the total PHQ-ADS is reported.
Measured: Compare at Baseline, 6-month and 12-month for any changes
Secondary outcomes (5)
Functional Impairment
Functional impairment was measured using the validated Short Form 12 Health Survey Version 2 (SF-12v2) which includes 12 items from the Short-Form 36 Health Survey and yields a physical and mental composite score as well as 8 subscale values: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Responses are tallied via a norm-based scoring algorithm provided by the assessment licensing company. Lower scores correspond with poorer health-related functioning; higher scores indicate better health-related functioning. The minimum score is 18.5; the maximum score is 142.6. Only the total composite score (the sum of both the physical and mental scales) is reported.
Measured: Compare at baseline, 6-month and 12-month for any changes
IBD-IBS Symptom Severity
IBD-IBS Symptom Severity was measured using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) to more accurately capture IBD symptom severity for many individuals with IBD, particularly those with inactive IBD but persistent functional GI symptoms (e.g., IBD-IBS). The IBS-SSS scores pain severity, pain frequency, abdominal bloating, bowel satisfaction and interference with life on a 0-100 scale with a total score of 500. A 50-point or more reduction in this score is considered clinically meaningful. Total scores range from 0 to 500 with higher scores indicating more severe symptoms. Answers to all questions are summed to achieve the total score. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) IBS. Only total scores are reported.
Measured: Compare at baseline, 6-month and 12-month for any changes
Health Care Utilization
Health care utilization was captured through EHR data to measure categorical (yes or no) instances of ED visits and inpatient hospitalizations at both 6- and 12-months post-enrollment.
Measured: Compare at baseline, 6-month and 12-months for any changes
Patient Engagement
Patient engagement was measured using the validated IBD Self-Efficacy Scale (IBD-SES) which assesses one's confidence level in managing stress and emotions, managing medical care, managing symptoms and disease, and maintaining remission. The IBD-SES measures self-management activities across four subscales (Stress and Emotions; Medical Care; Symptoms and Disease; Remission), with higher scores indicating greater confidence in self-management. Responses for each question are summed to produce one overall and four subscale scores. The total score range is between 29 and 290, with 29 indicating the lowest level of self-efficacy and 290 indicating the highest. Each item is scored 1-10, with 1 being assigned for responses of "Not confident at all" and a score of 10 assigned for responses of "Totally confident." Only total scores are reported.
Measured: Compare at baseline, 6-month and 12-month for any changes
Quality of Life
Quality of life was evaluated using the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ), a validated tool which measures physical, social, and emotional health-related quality of life (QOL) for patients with Crohn's disease and ulcerative colitis. On a 7-point scale, lower scores correspond with a lower perceived QOL, while higher scores represent a higher perceived QOL. Responses for each question are summed for a total score between 10 and 70, with 10 reflecting poor QOL and 70 reflecting high QOL. Each item is scored 1-7, with 1 being assigned for responses indicating the highest severity of symptoms, and 7 being assigned for those reflecting the lowest severity of symptoms. Only total scores are reported.
Measured: Compare at baseline, 6-month and 12-month for any changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Jul 2019
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between technology interventions and in-person interventions.
- Masking
- None (open label)
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, New York, The Cleveland Clinic, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Eva Szigethy, University of Pittsburgh
- Investigators
- Eva Szigethy, MD, PhD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985800
- Sponsor's protocol ID
- STUDY19020176
- Other IDs
- IHS-2017C3-8930
- Status last verified
- Aug 2025
- First submitted
- 28 May 2019
- Last updated
- 3 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared. Data is shared at the aggregate level
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions
- ClinicalTrials.gov ID
- NCT03985800
- Acronym / sponsor ID
- STUDY19020176
- Conditions
- Inflammatory Bowel Disease, Behavioral Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 657 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, New York, The Cleveland Clinic, Patient-Centered Outcomes Research Institute
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Posted 3 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison between technology interventions and in-person interventions.
| Arm | Type | Receives |
|---|---|---|
| TEAM-care as usual approach | Active comparator | Other: TEAMPatients 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. Minor modifications were made to the TEAM approach during the COVID-19 public health emergency to account for reduced face-to-face time without changing the underlying differentiation between the two models of delivering SMH care. |
| TECH-telehealth approach | Active comparator | Other: TECHEach 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Lack of smart phone, and/or are unable to speak, read or understand English at the minimum-required level.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEAMTEAM incorporates team-based care with traditional in-person clinic visits. The care team includes a gastroenterologist, nurse practitioner, nutritionist, social worker/behavioral health specialist, and a psychologist or psychiatrist. | Other | TEAM-care as usual approach |
| TECHTECH uses team-based care similar to TEAM, but in-person care is substituted with telemedicine (i.e., video visits and consultations) and digital behavioral health tools. | Other | TECH-telehealth approach |
Primary outcome
IBD Symptom Severity
Time frame: Compare scores at Baseline, 6-month and 12-month for any changes
IBD symptom severity was measured via a composite IBD Complexity Score developed by clinical researchers to quantify both biological and psychosocial domains of IBD within an SMH setting. It includes the sum of patient-reported responses to two scales: the PROMIS GI symptoms scale, evaluating four domains of gastrointestinal symptoms; and disease-specific PRO-2 disease severity indices taken from the Harvey Bradshaw Index (for individuals with Crohn's disease) and Ulcerative Colitis Activity Index (for individuals with ulcerative colitis). The complexity score is calculated by adding the value of the patient's PRO-2 to the cumulative PROMIS-GI score. Lower scores indicate lower symptom severity; higher scores indicate higher symptom severity. The minimum score is 0; the maximum score is open-ended based on patient response. Only the total IBD Complexity Score is reported.
Behavioral Health Symptom Severity
Time frame: Compare at Baseline, 6-month and 12-month for any changes
Behavioral health symptom severity was measured utilizing the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) - which combines the PHQ-8 and GAD-7 scales - as a composite measure of depression and anxiety. The Patient Health Questionnaire 8-item depression scale (PHQ-8) and 7-item Generalized Anxiety Disorder scale (GAD-7) are among the best validated and most commonly used depression and anxiety measures, respectively. The PHQ-ADS is the sum of the PHQ-8 and GAD-7, where a decrease in scores indicates a decrease in BH symptom severity; a decrease of 3-4 points indicates MCID. Lower scores indicate lower levels of behavioral health symptom severity; higher scores indicate higher symptom severity. The minimum score is 0; the maximum score is 45. Only the total PHQ-ADS is reported.
5 secondary outcomes
Functional Impairment
Time frame: Compare at baseline, 6-month and 12-month for any changes
IBD-IBS Symptom Severity
Time frame: Compare at baseline, 6-month and 12-month for any changes
Health Care Utilization
Time frame: Compare at baseline, 6-month and 12-months for any changes
Patient Engagement
Time frame: Compare at baseline, 6-month and 12-month for any changes
Quality of Life
Time frame: Compare at baseline, 6-month and 12-month for any changes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared. Data is shared at the aggregate level
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Szigethy, MD, PhD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAM and TECH in people with Inflammatory Bowel Disease and Behavioral Symptoms, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBD Symptom Severity (time frame: Compare scores at Baseline, 6-month and 12-month for any changes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.