Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes

NCT04345393 | Completed

• 3 other identifiers: GCO 18-2481STUDY-21-01875SSU00171350
• Study Type: interventional
• Target: 543
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

IBD; Treat to target; Digital transformation network; Social determinants of health; e-PRO

Outcome Measures

Primary Outcomes (2)

• Number of Participants in Disease Control

  Number of participants in disease control. 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 \<50 μg/g respectively for normal values.

  1 year after enrollment

• Change in Number of Unplanned Acute Care

  Change in number of unplanned acute care 1 year after enrollment as compared to baseline. 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.

  baseline

Secondary Outcomes (12)

• Northstar Digital Literacy Assessment

  1 year after enrollment

• Digital Disparities Module

  1 year after enrollment

• Overall Health Numeric Rating Scale [OHNRS]

  1 year after enrollment

• PROMIS Global scales

  1 year after enrollment

• Patient Health Questionnaire (PHQ-4)

  1 year after enrollment

Study Arms (2)

Digital Transformation Network (DTN) Program

EXPERIMENTAL

IBD patients at the 3 sites will be sent a message to their Smartphone

Behavioral: Digital Transformation Network (DTN) Program

Control Arm

ACTIVE COMPARATOR

Patients will enter the control group once they initially complete the ePRO and online assessment tools. They will remain in the control group, and then at set intervals each site will transition these patients into the DTN intervention arm.

Behavioral: Digital Transformation Network (DTN) Program

Interventions

Digital Transformation Network (DTN) Program BEHAVIORAL

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.

Control Arm; Digital Transformation Network (DTN) Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• The Cleveland Clinic: collaborator
• Northwestern University: collaborator
• RxHealth: collaborator
• University of California, Davis: collaborator

Study Sites (4)

University of California, Davis

Davis, California, 95616, United States

Location

RxHealth

Secaucus, New Jersey, 07094, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195-0001, United States

Location

Related Publications (1)

• 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.

  PMID: 40243391 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

dystrobrevin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Bruce Sands, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: April 14, 2020
• Study Start: May 14, 2022
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (4)