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NCT03128671 · ClinicalTrials.gov registry record · NA
Family Automated Voice Reorientation Study
A NA study, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 178
- Enrollment target
NCT03128671: Completed NA study, sponsored by University of Miami.
NCT03128671 is a NA study that has completed, run by University of Miami. The registered enrollment target is 178 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03128671, a NA study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 178 participants
- Enrollment target
Study Summary
This randomized clinical trial tests a cognitive reorientation intervention to prevent delirium in the intensive care unit using scripted audio messages, recorded by the patient's family and played at hourly intervals during daytime hours, to provide information about the ICU environment to the patient (the Family Automated Voice Reorientation intervention, FAVoR). The investigators hypothesize that providing ongoing orientation to the ICU environment through recorded audio messages in a voice familiar to the patient will enable the patient to more accurately interpret the environment and reduce risk of delirium. Increasing awareness of daytime by cuing patients during waking hours may also improve day/night orientation, nighttime sleep/rest, and further reduce risk of delirium.
Primary Outcome
Delirium will be assessed by study personnel, blinded to the group assignment, using Confusion Assessment Method-Intensive Care Unit (CAM-ICU)
Interventions
- BEHAVIORAL FAVoR Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2017-05-19 |
| Est. Completion | 2021-05-17 |
| Phase | NA |
What the finished NCT03128671 record still lists
NCT03128671 is an interventional study that assigns participants to a tested intervention. The registered 178 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 (87% lower).
The record links to 0 conditions, and to 1 intervention - of which FAVoR Intervention is the first listed.
NCT03128671 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03128671 about?
NCT03128671 is a clinical study titled "Family Automated Voice Reorientation Study". This randomized clinical trial tests a cognitive reorientation intervention to prevent delirium in the intensive care unit using scripted audio messages, recorded by the patient's family and played at hourly intervals during daytime hours, to provide information about the ICU environment to the pati...
What is the current status of trial NCT03128671?
This trial is currently completed. It is a NA study. The enrollment target is 178 participants. The study started on 2017-05-19. Estimated completion is 2021-05-17.
What interventions are being tested in trial NCT03128671?
The interventions under investigation include: FAVoR Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03128671?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03128671's enrollment target sits among peer trials
178 604th of 2000 higher than 1,397 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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