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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 is a Phase 2 study that has completed, run by University of Iowa. The registered enrollment target is 130 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02541799
The ClinicalTrials.gov registry entry for NCT02541799 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard care is the first listed.
NCT02541799 reports 0 study locations.
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.
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