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NCT04614844 · ClinicalTrials.gov registry record · NA

COVID-19 Responsive Intervention: Systems Improvement Simulations (CRI:SIS)

A NA study, sponsored by Yale University.

Completed
Registry status
NA
Development phase
159
Enrollment target

NCT04614844: Completed NA study, sponsored by Yale University.

NCT04614844 is a NA study that has completed, run by Yale University. The registered enrollment target is 159 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04614844, a NA study, has completed, sponsored by Yale University.

COMPLETED
Registry status
NA
Development phase
159 participants
Enrollment target

Study Summary

This will be a randomized control trial assessing the impact of CRI:SIS as a simulation-based preparedness intervention on physician stress levels through changes to heart rate variability (HRV) on shift while caring for COVID-19 patients and post-shift anxiety as measured by the State-Trait Anxiety Inventory (STAI). The aim is to test CRI:SIS to determine its effect on mitigating physician stress on shift and anxiety post-shift related to provision of COVID-19 care

Primary Outcome

The change in physician end-of-shift heart rate variability will be measured using the Hexoskin Smart Shirt. Changes in HRV will be averaged over the two post-intervention shift data collections to control for an anticipated shift-to-shift and patient-to-patient variability in stress response due to patient acuity and workload

Interventions

  • BEHAVIORAL Control
  • BEHAVIORAL Simulation Intervention

Trial Details

FieldValue
Enrollment Target 159 participants
Start Date 2021-01-06
Est. Completion 2022-09-02
Phase NA
Yale University

1,492 total trials

What the finished NCT04614844 record still lists

NCT04614844 is an interventional study that assigns participants to a tested intervention. The registered 159 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 (89% lower).

The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.

NCT04614844 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04614844 about?

NCT04614844 is a clinical study titled "COVID-19 Responsive Intervention: Systems Improvement Simulations (CRI:SIS)". This will be a randomized control trial assessing the impact of CRI:SIS as a simulation-based preparedness intervention on physician stress levels through changes to heart rate variability (HRV) on shift while caring for COVID-19 patients and post-shift anxiety as measured by the State-Trait Anxiety...

What is the current status of trial NCT04614844?

This trial is currently completed. It is a NA study. The enrollment target is 159 participants. The study started on 2021-01-06. Estimated completion is 2022-09-02.

What interventions are being tested in trial NCT04614844?

The interventions under investigation include: Control (BEHAVIORAL), Simulation Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT04614844?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04614844's enrollment target sits among peer trials

159 654th of 2000 higher than 1,347 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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Source: ClinicalTrials.gov NCT04614844, the US trial registry maintained by the National Library of Medicine. NCT04614844 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.