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NCT03381911 · ClinicalTrials.gov registry record · NA
ECA vs E-Document Explanation
A NA study, sponsored by Boston Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT03381911: Completed NA study, sponsored by Boston Medical Center.
NCT03381911 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03381911, a NA study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study Summary
This study will investigate how consent forms and other health care documents are explained to patients. The findings will be used to create a computer program that can successfully explain consent and other health-related forms to individuals who have difficulty reading and understanding consent forms on their own as a supplement to the normal consent process done in research settings. In a prior study, the investigators delivered a similar protocol, where subjects were first consented and then given a mock consent form (administered in 1 of 3 arms: RA, ECA, or ECA + RA). Subjects in this protocol struggled with the concept of a "mock" consent process, especially after they had just completed a consent process for the study itself. The current protocol, using deception research methods, aims to provide a more pure assessment of ECA consent vs the standard (here, E-consent) by waiving consent and delivering the sham consent as if it were reality. In the context of a protocol that employs deception methods, participants in the current study would be invited as healthy volunteers, and be randomized to 1 of 2 different consent processes to evaluate the relative benefits of different approaches for informed consent. After the knowledge tests have been completed, subjects will undergo a debriefing where they are made fully aware of the deception and its purpose. At that time, subjects will also be given the opportunity to "opt out" and not have their data included in the study results.
Primary Outcome
A knowledge test will be given to assess the subjects' level of comprehension of the informed consent form
Interventions
- OTHER Embodied Conversational Agent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-01-04 |
| Est. Completion | 2018-04-18 |
| Phase | NA |
What the finished NCT03381911 record still lists
NCT03381911 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Embodied Conversational Agent is the first listed.
NCT03381911 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03381911 about?
NCT03381911 is a clinical study titled "ECA vs E-Document Explanation". This study will investigate how consent forms and other health care documents are explained to patients. The findings will be used to create a computer program that can successfully explain consent and other health-related forms to individuals who have difficulty reading and understanding consent fo...
What is the current status of trial NCT03381911?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2018-01-04. Estimated completion is 2018-04-18.
What interventions are being tested in trial NCT03381911?
The interventions under investigation include: Embodied Conversational Agent (OTHER).
Who is sponsoring clinical trial NCT03381911?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03381911's enrollment target sits among peer trials
35 1564th of 2000 higher than 431 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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