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NCT04345393 · ClinicalTrials.gov registry record · NA
Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 543
- Enrollment target
NCT04345393: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT04345393 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 543 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04345393, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 543 participants
- Enrollment target
Study 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.
Primary Outcome
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 val
Interventions
- BEHAVIORAL Digital Transformation Network (DTN) Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 543 participants |
| Start Date | 2022-05-14 |
| Est. Completion | 2025-03-24 |
| Phase | NA |
What the finished NCT04345393 record still lists
NCT04345393 is an interventional study that assigns participants to a tested intervention. The registered 543 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which Digital Transformation Network (DTN) Program is the first listed.
NCT04345393 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04345393 about?
NCT04345393 is a clinical study titled "Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes". 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 quest...
What is the current status of trial NCT04345393?
This trial is currently completed. It is a NA study. The enrollment target is 543 participants. The study started on 2022-05-14. Estimated completion is 2025-03-24.
What interventions are being tested in trial NCT04345393?
The interventions under investigation include: Digital Transformation Network (DTN) Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT04345393?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04345393's enrollment target sits among peer trials
543 186th of 2000 higher than 1,814 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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