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NCT02541799 · ClinicalTrials.gov registry record · Phase 2
Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium
A Phase 2 study, sponsored by University of Iowa.
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
NCT02541799: Completed Phase 2 study, sponsored by University of Iowa.
NCT02541799 is a Phase 2 study that has completed, run by University of Iowa. The registered enrollment target is 130 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02541799, a Phase 2 study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
Study Summary
The investigators hypothesis is that patient comprehension of telemedicine-enabled research informed consent is not inferior to standard face-to-face research informed consent. The procotol will involve a prospective, randomized control trial to test the effectiveness of a telemedicine medium in obtaining research informed consent. Within a single emergency department, the investigators will conduct a simple, low risk randomized trial (single does of oral chlorhexideine to prevent hospital acquired pneumonia among adult patients with expected hospital admission). Prior to being approached for informed consent, potential participants will be randomized in a 1:1 allocation ratio to standard face-to-face consent vs. consent provided by audio-visual telemedicine. After standard clinical care, potential participants will be approached according to their allocation. Comprehension of research informed consent will be the primary outcome, and will be measured using the modified Quality of Informed Consent (QuIC) instrument.
Primary Outcome
Comprehension of research informed consent will be assessed within 30 minutes of approaching participants for study inclusion. The QuIC will be used to assess comprehension of the elements of research informed consent.
Interventions
- PROCEDURE Standard care
- PROCEDURE Audio-visual telemedicine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2015-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
What the finished NCT02541799 record still lists
NCT02541799 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Standard care is the first listed.
NCT02541799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02541799 about?
NCT02541799 is a clinical study titled "Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium". The investigators hypothesis is that patient comprehension of telemedicine-enabled research informed consent is not inferior to standard face-to-face research informed consent. The procotol will involve a prospective, randomized control trial to test the effectiveness of a telemedicine medium in ob...
What is the current status of trial NCT02541799?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2015-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02541799?
The interventions under investigation include: Standard care (PROCEDURE), Audio-visual telemedicine (PROCEDURE).
Who is sponsoring clinical trial NCT02541799?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02541799's enrollment target sits among peer trials
130 543rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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