Inflammatory Bowel Disease (IBD)NCT04345393
Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes
A study testing Digital Transformation Network (DTN) Program in people with Inflammatory Bowel Disease (IBD), run by Icahn School of Medicine at Mount Sinai at 4 sites in United States.
Trial summary
Delivery of healthcare has been traditionally limited to in-person visits or hospitalizations, while patients spend the majority of their time at home or work. Digital Medicine (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- Digital Transformation Network (DTN) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 659 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 May 2022to 24 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed Inflammatory Bowel Disease (IBD) will be enrolled into DTN in stepped-wedge cluster randomized trial
- Age greater than or equal to 18 years
- Ability to speak or understand English or Spanish Language.
Who cannot join
- Condition or disease that, in the opinion of the investigators, may make it exceedingly difficult for the patient to use DTN, including, but not limited to, advanced dementia.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cleveland Clinic
Cleveland, Ohio, 44195-0001
University of California, Davis
Davis, California, 95616
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
RxHealth
Secaucus, New Jersey, 07094
About this study
Delivery of healthcare has been traditionally limited to in-person visits or hospitalizations, while patients spend the majority of their time at home or work. Digital Medicine (e.g. apps, remote monitoring, telemedicine, patient reported outcomes) has the potential to bridge this gap, but the question remains as to how to translate it to mainstream practice while providing individualized recommendations to improve population health across organizations. Through the creation of a Digital Transformation Network (DTN) for Inflammatory Bowel Disease (IBD), the study team plans to reduce digital disparities and scientifically test the impact of these technologies in a clinical trial in three CTSA sites catering to diverse populations and communities.
Read the detailed description
Delivery of healthcare has been traditionally limited to in-person office visits or hospitalizations, while patients spent the majority of their time at home or work. Digital Medicine (e.g. apps, remote monitoring, telemedicine, patient reported outcomes ePRO has the potential to bridge this gap, but it is unclear how to implement in a mainstream clinical practice that can lead to high-level patient and provider adoption. Through the creation of a Digital Transformation Network (DTN) for Inflammatory Bowel Disease (IBD), the study team plans to reduce digital disparities and scientifically address the evidence gap of digital health interventions across populations and communities.
AIM I. Unify existing digital assets (mobile app, ePROs, assessment for digital disparities and behavioral health, referral to IBD home and health education) into an IBD Digital Therapeutics Toolkit and integrate with EHRs at 3 CTSA hubs. Hypothesis: Integration with EHRs will lead to higher adoption by providers and limit disruption of workflow.
AIM II: Establish baseline levels of digital connectivity, disease control, quality of life and care metrics in cohorts at the three IBD centers. Hypothesis: A multipronged approach of assessment through text, phone, an app, and in-person will yield higher adoption.
AIM III. Implement and evaluate precision-matched interventions (digital skills, social determinants, behavioral health, monitoring through apps, and referral to interdisciplinary care) among 1500 patients with IBD using a stepped-wedge, cluster- randomized trial. Hypothesis: Medical homes supported by a unified platform will translate to sustainable improvement in population health outcomes. Analyze the Impact of DTN interventions. The primary outcome will be the improvement of the percentage of patients in DTN in disease control and decrease in urgent care utilization (emergency department visits and hospitalization days) across the three CTSA sites.
AIM IV. Support sustainability and dissemination across CTSA sites. Hypothesis: The patient- centric DTN will be sustainable through alignment with value-based healthcare.
Anticipated Impact: About 2 million Americans suffer from IBD and many more with chronic inflammatory diseases. The study team hopes that this study will help the study team build an evidence-based approach to determine whether digital medicine can engage a diverse group of patients and improve outcomes; and if yes, how it can be reproduced and replicated across different settings to address theT3 and T4 translational gaps.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- Digital Transformation Network (DTN) Program
- Keywords
- IBD, Treat to target, Digital transformation network, Social determinants of health, e-PRO
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Transformation Network (DTN) ProgramBehavioural
Patients will be screened based on ePRO and online assessment tool results to be identified to be eligible for enrollment into the DTN program. The results of ePROs and online assessments will be used to precision match patients to in-person care at the IBD home or to IBDTx care pathways. RxUniverse platform allows the creation of adaptive pathways based on feedback loops that provide relevant on-demand resources based on patient care touch-points. For example, a patient with mild depression or anxiety, maybe offered an online DTx and if not useful, link to telepsychiatry or in-person psychiatry consultation. Patients will transition into the intervention DTN arm at set intervals by site.
| Study group | Role | What they receive |
|---|---|---|
| Digital Transformation Network (DTN) Program | Experimental | IBD patients at the 3 sites will be sent a message to their Smartphone Receives: Behavioral: Digital Transformation Network (DTN) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants in Disease Control
Proportion of participants in disease control at assessments at end of control period (week 0) and at end of intervention period (week 52). Disease control is defined by normalization of inflammatory markers and ePROs (PRO2<8 and PRO3<13). PRO2 measures stool frequency and bleeding while PRO3 measures the number of liquid or soft stools, abdominal pain and general well-being. Inflammatory markers including Erythrocyte Sedimentation Rate (ESR), C-Reactive Protein (CRP) and Fecal Calprotectin will be dichotomized using cut-offs of <30mm/hr, <5mg/L and <250 μg/g respectively for normal values.
Measured: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Change in Number of Unplanned Acute Care
Change in number of unplanned acute care. Unplanned acute care is defined as the number of ED visits and hospitalizations days 12 months before the intervention and the last 12 months of DTN intervention.
Measured: 12 months before intervention and 12 months after intervention
Secondary outcomes (11)
Northstar Digital Literacy Assessment
For participants who screened positive for needing assistance with digital connectivity and skills. Digital skills and connectivity will be assessed using the Northstar digital literacy assessment. A 17-item rating scale, with full score from 0 to 100, with score 85% or above achieve a passing score.
Measured: week 52
Digital Disparities Module
For participants who screened positive for needing assistance with digital connectivity and skills. The digital disparities module is still in development through SBIR. The digital disparities module will assess the impact of digital disparities module in improving digital skills and access to Internet using previously developed digital disparities assessment instrument. The scale for the digital disparities assessment full scale from 0 - 100 where a higher score indicates the patient has a higher level of disparity in digital connectivity, digital skills and digital usage.
Measured: 1 year after enrollment
Change in Overall Health Numeric Rating Scale [OHNRS]
OHNRS - Full scale from 0 to 10, higher score indicates better health outcomes
Measured: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Change in PROMIS Global Scales
Change in PROMIS Global scales is a 14-item measure that is part of the PROMIS Social Function. The measure refers to social roles, such as work and family responsibilities, and more discretionary social activities, such as leisure activity and relationships with friends. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Measured: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Change in Patient Health Questionnaire (PHQ-4)
The Patient Health Questionnaire (PHQ)-4 s a 4 item inventory. Anxiety subscale from 0-6, depression subscale from 0-6, with full scale from 0-12, higher score indicates more symptoms.
Measured: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Change in Patient Health Questionnaire (PHQ-8)
The Questionnaire Type 9 for Depression (PHQ-8) is a self-administered instrument. Full scale from 0-24, with higher score indicating more severe symptoms. As needed.
Measured: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Change in Generalized Anxiety Disorder Scale (GAD-7)
The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire. Full scale from 0-21, with higher score indicating more symptoms. As needed.
Measured: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Improvement in Mucosal Healing
Improvement in mucosal healing will be defined as the absence of inflammation on endoscopy (scoring systems) or imaging notes collected from EHR.
Measured: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Proportion of Participants With Medication Adherence
Proportion of participants with medication adherence will be assessed with the Visual Analog Scale (VAS) using <80% cut-off to designate non-adherence. Full Scale from 0 to 100 with higher score indicating more adherence.
Measured: End of Control Period (Week 0) and End of Intervention Period (Week 52)
System Usability Scale (SUS)
The system usability scale (SUS) is a 10-item Likert scale questionnaire. The range of scores is from 0 - 100 where a SUS score above 68 is considered average.
Measured: End of Intervention Period (Week 52)
Net Promoter Score
The Net Promoter is a 10 point scale and the full score ranges from -100 to 100 where a higher score translates to higher satisfaction with a product.
Measured: End of Intervention Period (Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start14 May 2022
- Primary completion24 Mar 2025
- Study completion24 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 1. Smartphone, and inform them about the DTN program through a description and embedded video. 2. Including SDH, behavioral health, lack of knowledge of quality metrics, or lack of Smartphone access or connectivity. 3. The IBD home or to IBDTx care pathways. RxUniverse platform allows the creation of adaptive pathways based on feedback loops that provide relevant on-demand resources based on patient care touch-points. 4. Digitally enabled population, or an Interactive Voice Response \[IVR\] for those who are not
- Masking
- None (open label)
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, Northwestern University, RxHealth, University of California, Davis, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Bruce E. Sands, Icahn School of Medicine at Mount Sinai
- Investigators
- Bruce Sands, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345393
- Sponsor's protocol ID
- GCO 18-2481
- Other IDs
- STUDY-21-01875, SSU00171350, U01TR002997, HSR 295476
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2020
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT04345393
- Acronym / sponsor ID
- GCO 18-2481
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- IBD, Treat to target, Digital transformation network, Social determinants of health, e-PRO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, Northwestern University, RxHealth, University of California, Davis, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 14 May 2022 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Posted 20 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Delivery of healthcare has been traditionally limited to in-person visits or hospitalizations, while patients spend the majority of their time at home or work. Digital Medicine (e.g. apps, remote monitoring, telemedicine, patient reported outcomes) has the potential to bridge this gap, but the question remains as to how to translate it to mainstream practice while providing individualized recommendations to improve population health across organizations. Through the creation of a Digital Transformation Network (DTN) for Inflammatory Bowel Disease (IBD), the study team plans to reduce digital disparities and scientifically test the impact of these technologies in a clinical trial in three CTSA sites catering to diverse populations and communities.
Detailed description
Delivery of healthcare has been traditionally limited to in-person office visits or hospitalizations, while patients spent the majority of their time at home or work. Digital Medicine (e.g. apps, remote monitoring, telemedicine, patient reported outcomes ePRO has the potential to bridge this gap, but it is unclear how to implement in a mainstream clinical practice that can lead to high-level patient and provider adoption. Through the creation of a Digital Transformation Network (DTN) for Inflammatory Bowel Disease (IBD), the study team plans to reduce digital disparities and scientifically address the evidence gap of digital health interventions across populations and communities.
AIM I. Unify existing digital assets (mobile app, ePROs, assessment for digital disparities and behavioral health, referral to IBD home and health education) into an IBD Digital Therapeutics Toolkit and integrate with EHRs at 3 CTSA hubs. Hypothesis: Integration with EHRs will lead to higher adoption by providers and limit disruption of workflow.
AIM II: Establish baseline levels of digital connectivity, disease control, quality of life and care metrics in cohorts at the three IBD centers. Hypothesis: A multipronged approach of assessment through text, phone, an app, and in-person will yield higher adoption.
AIM III. Implement and evaluate precision-matched interventions (digital skills, social determinants, behavioral health, monitoring through apps, and referral to interdisciplinary care) among 1500 patients with IBD using a stepped-wedge, cluster- randomized trial. Hypothesis: Medical homes supported by a unified platform will translate to sustainable improvement in population health outcomes. Analyze the Impact of DTN interventions. The primary outcome will be the improvement of the percentage of patients in DTN in disease control and decrease in urgent care utilization (emergency department visits and hospitalization days) across the three CTSA sites.
AIM IV. Support sustainability and dissemination across CTSA sites. Hypothesis: The patient- centric DTN will be sustainable through alignment with value-based healthcare.
Anticipated Impact: About 2 million Americans suffer from IBD and many more with chronic inflammatory diseases. The study team hopes that this study will help the study team build an evidence-based approach to determine whether digital medicine can engage a diverse group of patients and improve outcomes; and if yes, how it can be reproduced and replicated across different settings to address theT3 and T4 translational gaps.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1. Smartphone, and inform them about the DTN program through a description and embedded video. 2. Including SDH, behavioral health, lack of knowledge of quality metrics, or lack of Smartphone access or connectivity. 3. The IBD home or to IBDTx care pathways. RxUniverse platform allows the creation of adaptive pathways based on feedback loops that provide relevant on-demand resources based on patient care touch-points. 4. Digitally enabled population, or an Interactive Voice Response [IVR] for those who are not
| Arm | Type | Receives |
|---|---|---|
| Digital Transformation Network (DTN) Program | Experimental | Behavioral: Digital Transformation Network (DTN) ProgramIBD patients at the 3 sites will be sent a message to their Smartphone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with confirmed Inflammatory Bowel Disease (IBD) will be enrolled into DTN in stepped-wedge cluster randomized trial
- Age greater than or equal to 18 years
- Ability to speak or understand English or Spanish Language.
Key exclusion criteria (1 listed)
- Condition or disease that, in the opinion of the investigators, may make it exceedingly difficult for the patient to use DTN, including, but not limited to, advanced dementia.
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 |
|---|---|---|
| Digital Transformation Network (DTN) ProgramPatients will be screened based on ePRO and online assessment tool results to be identified to be eligible for enrollment into the DTN program. The results of ePROs and online assessments will be used to precision match patients to in-person care at the IBD home or to IBDTx care pathways. RxUniverse platform allows the creation of adaptive pathways based on feedback loops that provide relevant on-demand resources based on patient care touch-points. For example, a patient with mild depression or anxiety, maybe offered an online DTx and if not useful, link to telepsychiatry or in-person psychiatry consultation. Patients will transition into the intervention DTN arm at set intervals by site. | Behavioural | Digital Transformation Network (DTN) Program |
Primary outcome
Proportion of Participants in Disease Control
Time frame: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Proportion of participants in disease control at assessments at end of control period (week 0) and at end of intervention period (week 52). Disease control is defined by normalization of inflammatory markers and ePROs (PRO2<8 and PRO3<13). PRO2 measures stool frequency and bleeding while PRO3 measures the number of liquid or soft stools, abdominal pain and general well-being. Inflammatory markers including Erythrocyte Sedimentation Rate (ESR), C-Reactive Protein (CRP) and Fecal Calprotectin will be dichotomized using cut-offs of <30mm/hr, <5mg/L and <250 μg/g respectively for normal values.
Change in Number of Unplanned Acute Care
Time frame: 12 months before intervention and 12 months after intervention
Change in number of unplanned acute care. Unplanned acute care is defined as the number of ED visits and hospitalizations days 12 months before the intervention and the last 12 months of DTN intervention.
11 secondary outcomes
Northstar Digital Literacy Assessment
Time frame: week 52
Digital Disparities Module
Time frame: 1 year after enrollment
Change in Overall Health Numeric Rating Scale [OHNRS]
Time frame: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Change in PROMIS Global Scales
Time frame: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Change in Patient Health Questionnaire (PHQ-4)
Time frame: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Change in Patient Health Questionnaire (PHQ-8)
Time frame: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Change in Generalized Anxiety Disorder Scale (GAD-7)
Time frame: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Improvement in Mucosal Healing
Time frame: End of Control Period (Week 0) and End of Intervention Period (Week 52)
Proportion of Participants With Medication Adherence
Time frame: End of Control Period (Week 0) and End of Intervention Period (Week 52)
System Usability Scale (SUS)
Time frame: End of Intervention Period (Week 52)
Net Promoter Score
Time frame: End of Intervention Period (Week 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- Individual participant dataSharing planned: Yes
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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.
Bruce Sands, MD principal investigator
Icahn School of Medicine at Mount Sinai
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Transformation Network (DTN) Program in people with Inflammatory Bowel Disease (IBD), run by Icahn School of Medicine at Mount Sinai at 4 sites 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 3 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 20 Oct 2026). 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?
Proportion of Participants in Disease Control (time frame: End of Control Period (Week 0) and End of Intervention Period (Week 52)). 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?
On the ClinicalTrials.gov record for NCT04345393, which also lists 1 linked publication.
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 20 Oct 2026.