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NCT04305353 · ClinicalTrials.gov registry record · NA
Intensive Care Unit (ICU) Diary Project
A NA study of PTSD and Post ICU Syndrome, sponsored by Tulane University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04305353: Completed NA study of PTSD and Post ICU Syndrome, sponsored by Tulane University School of Medicine.
NCT04305353 is a NA study of PTSD and Post ICU Syndrome that has completed, run by Tulane University School of Medicine. The registered enrollment target is 60 participants, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04305353, a NA study of PTSD and Post ICU Syndrome, has completed, sponsored by Tulane University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, include ICU-related PTSD (post-traumatic stress disorder), depression and anxiety.
Primary Outcome
Revised Impact of Event Scales (IES-R) score, measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. Scores from 1-22 are consistent with mild PTSD, and scores greater than 22 signal clinically significant PTSD symptoms.
Conditions Studied
Interventions
- OTHER Diary (blank journal) plus PTSD psycho-education
- OTHER PTSD psycho-education alone
Study Locations (1)
Louisiana
- Tulane University School of Medicine - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-09-26 |
| Est. Completion | 2020-09-01 |
| Phase | NA |
What the finished NCT04305353 record still lists
NCT04305353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which Diary (blank journal) plus PTSD psycho-education is the first listed.
NCT04305353 reports a single indexed study location in Louisiana.
Frequently Asked Questions
What is clinical trial NCT04305353 about?
NCT04305353 is a clinical study titled "Intensive Care Unit (ICU) Diary Project". Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an interv...
What is the current status of trial NCT04305353?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2017-09-26. Estimated completion is 2020-09-01.
What conditions does trial NCT04305353 study?
This clinical trial studies the following conditions: PTSD, Post ICU Syndrome.
What interventions are being tested in trial NCT04305353?
The interventions under investigation include: Diary (blank journal) plus PTSD psycho-education (OTHER), PTSD psycho-education alone (OTHER).
Who is sponsoring clinical trial NCT04305353?
This trial is sponsored by Tulane University School of Medicine, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04305353 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04305353's enrollment target sits among peer trials
60 87th of 154 higher than 65 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD 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.
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